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1Northwest Center forPublic Health Practice
PRACTICAL ETHICAL amp LEGAL INFORMATION
FOR DISASTER MENTAL HEALTH RESEARCHERS
2Northwest Center forPublic Health Practice
CHILD AND FAMILY
DISASTER RESEARCH
TRAINING AND
EDUCATION
3Northwest Center forPublic Health Practice
Principal Investigators
bull Betty Pfefferbaum MD JD University of Oklahoma Health Sciences
Center
bull Alan M Steinberg PhD University of California Los Angeles
bull Robert S Pynoos MD MPHUniversity of California Los Angeles
bull John Fairbank PhDDuke University
4Northwest Center forPublic Health Practice
Federal Sponsors
bull NIMH National Institute of Mental Health
bull NINR National Institute of Nursing Research
bull SAMHSA Substance Abuse and Mental Health Services Administration
5Northwest Center forPublic Health Practice
Randal Beaton PhD EMTAdoptedadapted from John A Call PhD JDCrisis Management
Consultants
6Northwest Center forPublic Health Practice
CASE EXAMPLE
7Northwest Center forPublic Health Practice
You are working in a shelter after a hurricane and another mental health volunteer asks you to help her gather some
survivors together for a group CISD session She instructs you to go down the row of cots and select survivors
particularly families with children who appear upset and instruct them to assemble in a secluded corner of the gym
where some chairs have been set up The session is to begin in about an hour
What are the issues What should you do
8Northwest Center forPublic Health Practice
bull Provide practical legal amp ethical information for front-line post-disaster mental health researchers (and practitioners)
Purpose
9Northwest Center forPublic Health Practice
bull Appreciate the ethical and legal aspects of different phases and different types of disasters
bull Understand some of the legal amp ethical issues impacting both disaster mental health services and disaster mental health researchers
Goals
10Northwest Center forPublic Health Practice
Objectives
bull Develop competencies in recognizingbull Ethical issues involving standard of
practice informed consent confidentiality record keeping and supervision in the
provision of disaster mental health services
bull Legal issues involving professional liability licensure and HIPAA in the provision of disaster mental health services
11Northwest Center forPublic Health Practice
Objectives
bull Develop competencies in appreciatingbull The impact of statesrsquo disaster related statutes
on the provision of disaster mental health services amp research
bull The impact of federal statutes (eg HIPAA) when conducting disaster mental health research
bull The policies and guidelines that IRBs consider in approving human subject participation in disaster research
12Northwest Center forPublic Health Practice
Review Basic Disaster Concepts
bull Disasters have temporal phases
bull Disasters typology
The phase and type of disaster interact with legal and ethical parameters
13Northwest Center forPublic Health Practice
Psychosocial Phases of a Disaster
From Zunin amp Myers (2000)
14Northwest Center forPublic Health Practice
Types Of Disasters
bull Human made vs Natural disaster
bull Human made-neglect vs terrorism
bull Immediate vs Prolonged disaster
bull Natural-Hurricane vs pandemic
bull Terrorism-Bioterrorism vs explosion
15Northwest Center forPublic Health Practice
Legal and
Ethical Issues
16Northwest Center forPublic Health Practice
Questions
bull Do all professional ethical rules apply to mental health professionals during the chaos and confusion characteristic of the impact or heroic phase of a disaster
17Northwest Center forPublic Health Practice
CASE EXAMPLE
18Northwest Center forPublic Health Practice
You are working in a shelter after a hurricane and another mental health volunteer asks you to help her gather some survivors
together for a group CISD session She instructs you to go down the row of cots and select survivors particularly families with
children who appear upset and instruct them to assemble in a secluded corner of the gym where some chairs have been set
up The session is to begin in about an hour
What are the issues What should you do
19Northwest Center forPublic Health Practice
Issues
bull Standard of Practice At this juncture there really is no community standard
20Northwest Center forPublic Health Practice
NIMH Guidance(2002)
bull Early brief focused intervention can reduce stress
bull Selected cognitive behavioral approaches may help ASD PTSD amp depression
httpwwwnimhnihgovpublicatmassviolencepdf
21Northwest Center forPublic Health Practice
NIMH Guidance (2002)
bull Early intervention in form of recitals of events and emotions do not consistently help ie CISD is not necessarily helpful
bull No evidence that EMDR as an early intervention as treatment of choice over other practices
22Northwest Center forPublic Health Practice
APA Ethical RulesGuidelines for Psychologists
bull APA Ethical Rule sect 201 amp ASPPB Code of Conduct sect III (A) (4)
bull Psychologists provides services within the boundaries of their competence
bull In emerging areas psychologists nevertheless take reasonable steps to ensure competence
American Psychological Association Code of Ethics httpwwwapaorgethicscode2002html
23Northwest Center forPublic Health Practice
APA Rule- Emergency Provision
bull APA Ethical Rule sect 202
bull Psychologists may provide services for which they have not been trained in emergency situations- Would this rule apply to the disillusionment phase of a disaster (Days or weeks following a disaster)
24Northwest Center forPublic Health Practice
Analysis
bull Standard of Practice
bull So if there is none what is the Disaster Mental Health Professional supposed to do
25Northwest Center forPublic Health Practice
Recommended Guideline
ASPPB Code of Conduct III(A)(4)statesmdashrdquoengage in ongoing consultation amp inform clients of the innovative nature amp known risks of the servicerdquo
Association of State and Provincial Boards of Psychology Code of Conduct available at
httpwwwokgovOSBEPdocumentsASPPB_Code_of_Conduct_20055B15Dpdf
26Northwest Center forPublic Health Practice
Issues
bull Informed Consent
bull Itrsquos required but how do I get it
27Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull Psychologists must obtain informed consent before providing services
bull For persons who are legally incapable of giving informed consent (eg children) psychologists must obtain informed assent
Exemplar of Informed Assent Form for child mental health study Claremont Grad School httpwwwcgueduincludeInformed_AssentFormdoc
28Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull For services for which generally recognized techniques have yet not been established psychologists inform the client of the developing nature amp potential risks of the procedure
29Northwest Center forPublic Health Practice
Analysis
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sectIII (D) (1)
bull Informed consent includes discussion of nature amp course of treatment fees involvement of third parties limits to confidentiality and the provision of sufficient opportunity for the client to ask questions
30Northwest Center forPublic Health Practice
NCPTSD Guidance
bull Introduce yourself with your name and title and describe your role Ask permission to talk to them and explain your objective of finding out whether there is anything you can do to make things easier or helping with ways to help themselves feel betterhellipWhen making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission When speaking with a child in distress when no adult is present it is important to find a parent or caregiver to let them know about your role and seek permission
National Center for PTSD Guidance for mental health providers in acute phase httpwwwncptsdvagovncmainindexjsp
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
2Northwest Center forPublic Health Practice
CHILD AND FAMILY
DISASTER RESEARCH
TRAINING AND
EDUCATION
3Northwest Center forPublic Health Practice
Principal Investigators
bull Betty Pfefferbaum MD JD University of Oklahoma Health Sciences
Center
bull Alan M Steinberg PhD University of California Los Angeles
bull Robert S Pynoos MD MPHUniversity of California Los Angeles
bull John Fairbank PhDDuke University
4Northwest Center forPublic Health Practice
Federal Sponsors
bull NIMH National Institute of Mental Health
bull NINR National Institute of Nursing Research
bull SAMHSA Substance Abuse and Mental Health Services Administration
5Northwest Center forPublic Health Practice
Randal Beaton PhD EMTAdoptedadapted from John A Call PhD JDCrisis Management
Consultants
6Northwest Center forPublic Health Practice
CASE EXAMPLE
7Northwest Center forPublic Health Practice
You are working in a shelter after a hurricane and another mental health volunteer asks you to help her gather some
survivors together for a group CISD session She instructs you to go down the row of cots and select survivors
particularly families with children who appear upset and instruct them to assemble in a secluded corner of the gym
where some chairs have been set up The session is to begin in about an hour
What are the issues What should you do
8Northwest Center forPublic Health Practice
bull Provide practical legal amp ethical information for front-line post-disaster mental health researchers (and practitioners)
Purpose
9Northwest Center forPublic Health Practice
bull Appreciate the ethical and legal aspects of different phases and different types of disasters
bull Understand some of the legal amp ethical issues impacting both disaster mental health services and disaster mental health researchers
Goals
10Northwest Center forPublic Health Practice
Objectives
bull Develop competencies in recognizingbull Ethical issues involving standard of
practice informed consent confidentiality record keeping and supervision in the
provision of disaster mental health services
bull Legal issues involving professional liability licensure and HIPAA in the provision of disaster mental health services
11Northwest Center forPublic Health Practice
Objectives
bull Develop competencies in appreciatingbull The impact of statesrsquo disaster related statutes
on the provision of disaster mental health services amp research
bull The impact of federal statutes (eg HIPAA) when conducting disaster mental health research
bull The policies and guidelines that IRBs consider in approving human subject participation in disaster research
12Northwest Center forPublic Health Practice
Review Basic Disaster Concepts
bull Disasters have temporal phases
bull Disasters typology
The phase and type of disaster interact with legal and ethical parameters
13Northwest Center forPublic Health Practice
Psychosocial Phases of a Disaster
From Zunin amp Myers (2000)
14Northwest Center forPublic Health Practice
Types Of Disasters
bull Human made vs Natural disaster
bull Human made-neglect vs terrorism
bull Immediate vs Prolonged disaster
bull Natural-Hurricane vs pandemic
bull Terrorism-Bioterrorism vs explosion
15Northwest Center forPublic Health Practice
Legal and
Ethical Issues
16Northwest Center forPublic Health Practice
Questions
bull Do all professional ethical rules apply to mental health professionals during the chaos and confusion characteristic of the impact or heroic phase of a disaster
17Northwest Center forPublic Health Practice
CASE EXAMPLE
18Northwest Center forPublic Health Practice
You are working in a shelter after a hurricane and another mental health volunteer asks you to help her gather some survivors
together for a group CISD session She instructs you to go down the row of cots and select survivors particularly families with
children who appear upset and instruct them to assemble in a secluded corner of the gym where some chairs have been set
up The session is to begin in about an hour
What are the issues What should you do
19Northwest Center forPublic Health Practice
Issues
bull Standard of Practice At this juncture there really is no community standard
20Northwest Center forPublic Health Practice
NIMH Guidance(2002)
bull Early brief focused intervention can reduce stress
bull Selected cognitive behavioral approaches may help ASD PTSD amp depression
httpwwwnimhnihgovpublicatmassviolencepdf
21Northwest Center forPublic Health Practice
NIMH Guidance (2002)
bull Early intervention in form of recitals of events and emotions do not consistently help ie CISD is not necessarily helpful
bull No evidence that EMDR as an early intervention as treatment of choice over other practices
22Northwest Center forPublic Health Practice
APA Ethical RulesGuidelines for Psychologists
bull APA Ethical Rule sect 201 amp ASPPB Code of Conduct sect III (A) (4)
bull Psychologists provides services within the boundaries of their competence
bull In emerging areas psychologists nevertheless take reasonable steps to ensure competence
American Psychological Association Code of Ethics httpwwwapaorgethicscode2002html
23Northwest Center forPublic Health Practice
APA Rule- Emergency Provision
bull APA Ethical Rule sect 202
bull Psychologists may provide services for which they have not been trained in emergency situations- Would this rule apply to the disillusionment phase of a disaster (Days or weeks following a disaster)
24Northwest Center forPublic Health Practice
Analysis
bull Standard of Practice
bull So if there is none what is the Disaster Mental Health Professional supposed to do
25Northwest Center forPublic Health Practice
Recommended Guideline
ASPPB Code of Conduct III(A)(4)statesmdashrdquoengage in ongoing consultation amp inform clients of the innovative nature amp known risks of the servicerdquo
Association of State and Provincial Boards of Psychology Code of Conduct available at
httpwwwokgovOSBEPdocumentsASPPB_Code_of_Conduct_20055B15Dpdf
26Northwest Center forPublic Health Practice
Issues
bull Informed Consent
bull Itrsquos required but how do I get it
27Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull Psychologists must obtain informed consent before providing services
bull For persons who are legally incapable of giving informed consent (eg children) psychologists must obtain informed assent
Exemplar of Informed Assent Form for child mental health study Claremont Grad School httpwwwcgueduincludeInformed_AssentFormdoc
28Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull For services for which generally recognized techniques have yet not been established psychologists inform the client of the developing nature amp potential risks of the procedure
29Northwest Center forPublic Health Practice
Analysis
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sectIII (D) (1)
bull Informed consent includes discussion of nature amp course of treatment fees involvement of third parties limits to confidentiality and the provision of sufficient opportunity for the client to ask questions
30Northwest Center forPublic Health Practice
NCPTSD Guidance
bull Introduce yourself with your name and title and describe your role Ask permission to talk to them and explain your objective of finding out whether there is anything you can do to make things easier or helping with ways to help themselves feel betterhellipWhen making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission When speaking with a child in distress when no adult is present it is important to find a parent or caregiver to let them know about your role and seek permission
National Center for PTSD Guidance for mental health providers in acute phase httpwwwncptsdvagovncmainindexjsp
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
3Northwest Center forPublic Health Practice
Principal Investigators
bull Betty Pfefferbaum MD JD University of Oklahoma Health Sciences
Center
bull Alan M Steinberg PhD University of California Los Angeles
bull Robert S Pynoos MD MPHUniversity of California Los Angeles
bull John Fairbank PhDDuke University
4Northwest Center forPublic Health Practice
Federal Sponsors
bull NIMH National Institute of Mental Health
bull NINR National Institute of Nursing Research
bull SAMHSA Substance Abuse and Mental Health Services Administration
5Northwest Center forPublic Health Practice
Randal Beaton PhD EMTAdoptedadapted from John A Call PhD JDCrisis Management
Consultants
6Northwest Center forPublic Health Practice
CASE EXAMPLE
7Northwest Center forPublic Health Practice
You are working in a shelter after a hurricane and another mental health volunteer asks you to help her gather some
survivors together for a group CISD session She instructs you to go down the row of cots and select survivors
particularly families with children who appear upset and instruct them to assemble in a secluded corner of the gym
where some chairs have been set up The session is to begin in about an hour
What are the issues What should you do
8Northwest Center forPublic Health Practice
bull Provide practical legal amp ethical information for front-line post-disaster mental health researchers (and practitioners)
Purpose
9Northwest Center forPublic Health Practice
bull Appreciate the ethical and legal aspects of different phases and different types of disasters
bull Understand some of the legal amp ethical issues impacting both disaster mental health services and disaster mental health researchers
Goals
10Northwest Center forPublic Health Practice
Objectives
bull Develop competencies in recognizingbull Ethical issues involving standard of
practice informed consent confidentiality record keeping and supervision in the
provision of disaster mental health services
bull Legal issues involving professional liability licensure and HIPAA in the provision of disaster mental health services
11Northwest Center forPublic Health Practice
Objectives
bull Develop competencies in appreciatingbull The impact of statesrsquo disaster related statutes
on the provision of disaster mental health services amp research
bull The impact of federal statutes (eg HIPAA) when conducting disaster mental health research
bull The policies and guidelines that IRBs consider in approving human subject participation in disaster research
12Northwest Center forPublic Health Practice
Review Basic Disaster Concepts
bull Disasters have temporal phases
bull Disasters typology
The phase and type of disaster interact with legal and ethical parameters
13Northwest Center forPublic Health Practice
Psychosocial Phases of a Disaster
From Zunin amp Myers (2000)
14Northwest Center forPublic Health Practice
Types Of Disasters
bull Human made vs Natural disaster
bull Human made-neglect vs terrorism
bull Immediate vs Prolonged disaster
bull Natural-Hurricane vs pandemic
bull Terrorism-Bioterrorism vs explosion
15Northwest Center forPublic Health Practice
Legal and
Ethical Issues
16Northwest Center forPublic Health Practice
Questions
bull Do all professional ethical rules apply to mental health professionals during the chaos and confusion characteristic of the impact or heroic phase of a disaster
17Northwest Center forPublic Health Practice
CASE EXAMPLE
18Northwest Center forPublic Health Practice
You are working in a shelter after a hurricane and another mental health volunteer asks you to help her gather some survivors
together for a group CISD session She instructs you to go down the row of cots and select survivors particularly families with
children who appear upset and instruct them to assemble in a secluded corner of the gym where some chairs have been set
up The session is to begin in about an hour
What are the issues What should you do
19Northwest Center forPublic Health Practice
Issues
bull Standard of Practice At this juncture there really is no community standard
20Northwest Center forPublic Health Practice
NIMH Guidance(2002)
bull Early brief focused intervention can reduce stress
bull Selected cognitive behavioral approaches may help ASD PTSD amp depression
httpwwwnimhnihgovpublicatmassviolencepdf
21Northwest Center forPublic Health Practice
NIMH Guidance (2002)
bull Early intervention in form of recitals of events and emotions do not consistently help ie CISD is not necessarily helpful
bull No evidence that EMDR as an early intervention as treatment of choice over other practices
22Northwest Center forPublic Health Practice
APA Ethical RulesGuidelines for Psychologists
bull APA Ethical Rule sect 201 amp ASPPB Code of Conduct sect III (A) (4)
bull Psychologists provides services within the boundaries of their competence
bull In emerging areas psychologists nevertheless take reasonable steps to ensure competence
American Psychological Association Code of Ethics httpwwwapaorgethicscode2002html
23Northwest Center forPublic Health Practice
APA Rule- Emergency Provision
bull APA Ethical Rule sect 202
bull Psychologists may provide services for which they have not been trained in emergency situations- Would this rule apply to the disillusionment phase of a disaster (Days or weeks following a disaster)
24Northwest Center forPublic Health Practice
Analysis
bull Standard of Practice
bull So if there is none what is the Disaster Mental Health Professional supposed to do
25Northwest Center forPublic Health Practice
Recommended Guideline
ASPPB Code of Conduct III(A)(4)statesmdashrdquoengage in ongoing consultation amp inform clients of the innovative nature amp known risks of the servicerdquo
Association of State and Provincial Boards of Psychology Code of Conduct available at
httpwwwokgovOSBEPdocumentsASPPB_Code_of_Conduct_20055B15Dpdf
26Northwest Center forPublic Health Practice
Issues
bull Informed Consent
bull Itrsquos required but how do I get it
27Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull Psychologists must obtain informed consent before providing services
bull For persons who are legally incapable of giving informed consent (eg children) psychologists must obtain informed assent
Exemplar of Informed Assent Form for child mental health study Claremont Grad School httpwwwcgueduincludeInformed_AssentFormdoc
28Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull For services for which generally recognized techniques have yet not been established psychologists inform the client of the developing nature amp potential risks of the procedure
29Northwest Center forPublic Health Practice
Analysis
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sectIII (D) (1)
bull Informed consent includes discussion of nature amp course of treatment fees involvement of third parties limits to confidentiality and the provision of sufficient opportunity for the client to ask questions
30Northwest Center forPublic Health Practice
NCPTSD Guidance
bull Introduce yourself with your name and title and describe your role Ask permission to talk to them and explain your objective of finding out whether there is anything you can do to make things easier or helping with ways to help themselves feel betterhellipWhen making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission When speaking with a child in distress when no adult is present it is important to find a parent or caregiver to let them know about your role and seek permission
National Center for PTSD Guidance for mental health providers in acute phase httpwwwncptsdvagovncmainindexjsp
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
4Northwest Center forPublic Health Practice
Federal Sponsors
bull NIMH National Institute of Mental Health
bull NINR National Institute of Nursing Research
bull SAMHSA Substance Abuse and Mental Health Services Administration
5Northwest Center forPublic Health Practice
Randal Beaton PhD EMTAdoptedadapted from John A Call PhD JDCrisis Management
Consultants
6Northwest Center forPublic Health Practice
CASE EXAMPLE
7Northwest Center forPublic Health Practice
You are working in a shelter after a hurricane and another mental health volunteer asks you to help her gather some
survivors together for a group CISD session She instructs you to go down the row of cots and select survivors
particularly families with children who appear upset and instruct them to assemble in a secluded corner of the gym
where some chairs have been set up The session is to begin in about an hour
What are the issues What should you do
8Northwest Center forPublic Health Practice
bull Provide practical legal amp ethical information for front-line post-disaster mental health researchers (and practitioners)
Purpose
9Northwest Center forPublic Health Practice
bull Appreciate the ethical and legal aspects of different phases and different types of disasters
bull Understand some of the legal amp ethical issues impacting both disaster mental health services and disaster mental health researchers
Goals
10Northwest Center forPublic Health Practice
Objectives
bull Develop competencies in recognizingbull Ethical issues involving standard of
practice informed consent confidentiality record keeping and supervision in the
provision of disaster mental health services
bull Legal issues involving professional liability licensure and HIPAA in the provision of disaster mental health services
11Northwest Center forPublic Health Practice
Objectives
bull Develop competencies in appreciatingbull The impact of statesrsquo disaster related statutes
on the provision of disaster mental health services amp research
bull The impact of federal statutes (eg HIPAA) when conducting disaster mental health research
bull The policies and guidelines that IRBs consider in approving human subject participation in disaster research
12Northwest Center forPublic Health Practice
Review Basic Disaster Concepts
bull Disasters have temporal phases
bull Disasters typology
The phase and type of disaster interact with legal and ethical parameters
13Northwest Center forPublic Health Practice
Psychosocial Phases of a Disaster
From Zunin amp Myers (2000)
14Northwest Center forPublic Health Practice
Types Of Disasters
bull Human made vs Natural disaster
bull Human made-neglect vs terrorism
bull Immediate vs Prolonged disaster
bull Natural-Hurricane vs pandemic
bull Terrorism-Bioterrorism vs explosion
15Northwest Center forPublic Health Practice
Legal and
Ethical Issues
16Northwest Center forPublic Health Practice
Questions
bull Do all professional ethical rules apply to mental health professionals during the chaos and confusion characteristic of the impact or heroic phase of a disaster
17Northwest Center forPublic Health Practice
CASE EXAMPLE
18Northwest Center forPublic Health Practice
You are working in a shelter after a hurricane and another mental health volunteer asks you to help her gather some survivors
together for a group CISD session She instructs you to go down the row of cots and select survivors particularly families with
children who appear upset and instruct them to assemble in a secluded corner of the gym where some chairs have been set
up The session is to begin in about an hour
What are the issues What should you do
19Northwest Center forPublic Health Practice
Issues
bull Standard of Practice At this juncture there really is no community standard
20Northwest Center forPublic Health Practice
NIMH Guidance(2002)
bull Early brief focused intervention can reduce stress
bull Selected cognitive behavioral approaches may help ASD PTSD amp depression
httpwwwnimhnihgovpublicatmassviolencepdf
21Northwest Center forPublic Health Practice
NIMH Guidance (2002)
bull Early intervention in form of recitals of events and emotions do not consistently help ie CISD is not necessarily helpful
bull No evidence that EMDR as an early intervention as treatment of choice over other practices
22Northwest Center forPublic Health Practice
APA Ethical RulesGuidelines for Psychologists
bull APA Ethical Rule sect 201 amp ASPPB Code of Conduct sect III (A) (4)
bull Psychologists provides services within the boundaries of their competence
bull In emerging areas psychologists nevertheless take reasonable steps to ensure competence
American Psychological Association Code of Ethics httpwwwapaorgethicscode2002html
23Northwest Center forPublic Health Practice
APA Rule- Emergency Provision
bull APA Ethical Rule sect 202
bull Psychologists may provide services for which they have not been trained in emergency situations- Would this rule apply to the disillusionment phase of a disaster (Days or weeks following a disaster)
24Northwest Center forPublic Health Practice
Analysis
bull Standard of Practice
bull So if there is none what is the Disaster Mental Health Professional supposed to do
25Northwest Center forPublic Health Practice
Recommended Guideline
ASPPB Code of Conduct III(A)(4)statesmdashrdquoengage in ongoing consultation amp inform clients of the innovative nature amp known risks of the servicerdquo
Association of State and Provincial Boards of Psychology Code of Conduct available at
httpwwwokgovOSBEPdocumentsASPPB_Code_of_Conduct_20055B15Dpdf
26Northwest Center forPublic Health Practice
Issues
bull Informed Consent
bull Itrsquos required but how do I get it
27Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull Psychologists must obtain informed consent before providing services
bull For persons who are legally incapable of giving informed consent (eg children) psychologists must obtain informed assent
Exemplar of Informed Assent Form for child mental health study Claremont Grad School httpwwwcgueduincludeInformed_AssentFormdoc
28Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull For services for which generally recognized techniques have yet not been established psychologists inform the client of the developing nature amp potential risks of the procedure
29Northwest Center forPublic Health Practice
Analysis
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sectIII (D) (1)
bull Informed consent includes discussion of nature amp course of treatment fees involvement of third parties limits to confidentiality and the provision of sufficient opportunity for the client to ask questions
30Northwest Center forPublic Health Practice
NCPTSD Guidance
bull Introduce yourself with your name and title and describe your role Ask permission to talk to them and explain your objective of finding out whether there is anything you can do to make things easier or helping with ways to help themselves feel betterhellipWhen making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission When speaking with a child in distress when no adult is present it is important to find a parent or caregiver to let them know about your role and seek permission
National Center for PTSD Guidance for mental health providers in acute phase httpwwwncptsdvagovncmainindexjsp
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
5Northwest Center forPublic Health Practice
Randal Beaton PhD EMTAdoptedadapted from John A Call PhD JDCrisis Management
Consultants
6Northwest Center forPublic Health Practice
CASE EXAMPLE
7Northwest Center forPublic Health Practice
You are working in a shelter after a hurricane and another mental health volunteer asks you to help her gather some
survivors together for a group CISD session She instructs you to go down the row of cots and select survivors
particularly families with children who appear upset and instruct them to assemble in a secluded corner of the gym
where some chairs have been set up The session is to begin in about an hour
What are the issues What should you do
8Northwest Center forPublic Health Practice
bull Provide practical legal amp ethical information for front-line post-disaster mental health researchers (and practitioners)
Purpose
9Northwest Center forPublic Health Practice
bull Appreciate the ethical and legal aspects of different phases and different types of disasters
bull Understand some of the legal amp ethical issues impacting both disaster mental health services and disaster mental health researchers
Goals
10Northwest Center forPublic Health Practice
Objectives
bull Develop competencies in recognizingbull Ethical issues involving standard of
practice informed consent confidentiality record keeping and supervision in the
provision of disaster mental health services
bull Legal issues involving professional liability licensure and HIPAA in the provision of disaster mental health services
11Northwest Center forPublic Health Practice
Objectives
bull Develop competencies in appreciatingbull The impact of statesrsquo disaster related statutes
on the provision of disaster mental health services amp research
bull The impact of federal statutes (eg HIPAA) when conducting disaster mental health research
bull The policies and guidelines that IRBs consider in approving human subject participation in disaster research
12Northwest Center forPublic Health Practice
Review Basic Disaster Concepts
bull Disasters have temporal phases
bull Disasters typology
The phase and type of disaster interact with legal and ethical parameters
13Northwest Center forPublic Health Practice
Psychosocial Phases of a Disaster
From Zunin amp Myers (2000)
14Northwest Center forPublic Health Practice
Types Of Disasters
bull Human made vs Natural disaster
bull Human made-neglect vs terrorism
bull Immediate vs Prolonged disaster
bull Natural-Hurricane vs pandemic
bull Terrorism-Bioterrorism vs explosion
15Northwest Center forPublic Health Practice
Legal and
Ethical Issues
16Northwest Center forPublic Health Practice
Questions
bull Do all professional ethical rules apply to mental health professionals during the chaos and confusion characteristic of the impact or heroic phase of a disaster
17Northwest Center forPublic Health Practice
CASE EXAMPLE
18Northwest Center forPublic Health Practice
You are working in a shelter after a hurricane and another mental health volunteer asks you to help her gather some survivors
together for a group CISD session She instructs you to go down the row of cots and select survivors particularly families with
children who appear upset and instruct them to assemble in a secluded corner of the gym where some chairs have been set
up The session is to begin in about an hour
What are the issues What should you do
19Northwest Center forPublic Health Practice
Issues
bull Standard of Practice At this juncture there really is no community standard
20Northwest Center forPublic Health Practice
NIMH Guidance(2002)
bull Early brief focused intervention can reduce stress
bull Selected cognitive behavioral approaches may help ASD PTSD amp depression
httpwwwnimhnihgovpublicatmassviolencepdf
21Northwest Center forPublic Health Practice
NIMH Guidance (2002)
bull Early intervention in form of recitals of events and emotions do not consistently help ie CISD is not necessarily helpful
bull No evidence that EMDR as an early intervention as treatment of choice over other practices
22Northwest Center forPublic Health Practice
APA Ethical RulesGuidelines for Psychologists
bull APA Ethical Rule sect 201 amp ASPPB Code of Conduct sect III (A) (4)
bull Psychologists provides services within the boundaries of their competence
bull In emerging areas psychologists nevertheless take reasonable steps to ensure competence
American Psychological Association Code of Ethics httpwwwapaorgethicscode2002html
23Northwest Center forPublic Health Practice
APA Rule- Emergency Provision
bull APA Ethical Rule sect 202
bull Psychologists may provide services for which they have not been trained in emergency situations- Would this rule apply to the disillusionment phase of a disaster (Days or weeks following a disaster)
24Northwest Center forPublic Health Practice
Analysis
bull Standard of Practice
bull So if there is none what is the Disaster Mental Health Professional supposed to do
25Northwest Center forPublic Health Practice
Recommended Guideline
ASPPB Code of Conduct III(A)(4)statesmdashrdquoengage in ongoing consultation amp inform clients of the innovative nature amp known risks of the servicerdquo
Association of State and Provincial Boards of Psychology Code of Conduct available at
httpwwwokgovOSBEPdocumentsASPPB_Code_of_Conduct_20055B15Dpdf
26Northwest Center forPublic Health Practice
Issues
bull Informed Consent
bull Itrsquos required but how do I get it
27Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull Psychologists must obtain informed consent before providing services
bull For persons who are legally incapable of giving informed consent (eg children) psychologists must obtain informed assent
Exemplar of Informed Assent Form for child mental health study Claremont Grad School httpwwwcgueduincludeInformed_AssentFormdoc
28Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull For services for which generally recognized techniques have yet not been established psychologists inform the client of the developing nature amp potential risks of the procedure
29Northwest Center forPublic Health Practice
Analysis
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sectIII (D) (1)
bull Informed consent includes discussion of nature amp course of treatment fees involvement of third parties limits to confidentiality and the provision of sufficient opportunity for the client to ask questions
30Northwest Center forPublic Health Practice
NCPTSD Guidance
bull Introduce yourself with your name and title and describe your role Ask permission to talk to them and explain your objective of finding out whether there is anything you can do to make things easier or helping with ways to help themselves feel betterhellipWhen making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission When speaking with a child in distress when no adult is present it is important to find a parent or caregiver to let them know about your role and seek permission
National Center for PTSD Guidance for mental health providers in acute phase httpwwwncptsdvagovncmainindexjsp
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
6Northwest Center forPublic Health Practice
CASE EXAMPLE
7Northwest Center forPublic Health Practice
You are working in a shelter after a hurricane and another mental health volunteer asks you to help her gather some
survivors together for a group CISD session She instructs you to go down the row of cots and select survivors
particularly families with children who appear upset and instruct them to assemble in a secluded corner of the gym
where some chairs have been set up The session is to begin in about an hour
What are the issues What should you do
8Northwest Center forPublic Health Practice
bull Provide practical legal amp ethical information for front-line post-disaster mental health researchers (and practitioners)
Purpose
9Northwest Center forPublic Health Practice
bull Appreciate the ethical and legal aspects of different phases and different types of disasters
bull Understand some of the legal amp ethical issues impacting both disaster mental health services and disaster mental health researchers
Goals
10Northwest Center forPublic Health Practice
Objectives
bull Develop competencies in recognizingbull Ethical issues involving standard of
practice informed consent confidentiality record keeping and supervision in the
provision of disaster mental health services
bull Legal issues involving professional liability licensure and HIPAA in the provision of disaster mental health services
11Northwest Center forPublic Health Practice
Objectives
bull Develop competencies in appreciatingbull The impact of statesrsquo disaster related statutes
on the provision of disaster mental health services amp research
bull The impact of federal statutes (eg HIPAA) when conducting disaster mental health research
bull The policies and guidelines that IRBs consider in approving human subject participation in disaster research
12Northwest Center forPublic Health Practice
Review Basic Disaster Concepts
bull Disasters have temporal phases
bull Disasters typology
The phase and type of disaster interact with legal and ethical parameters
13Northwest Center forPublic Health Practice
Psychosocial Phases of a Disaster
From Zunin amp Myers (2000)
14Northwest Center forPublic Health Practice
Types Of Disasters
bull Human made vs Natural disaster
bull Human made-neglect vs terrorism
bull Immediate vs Prolonged disaster
bull Natural-Hurricane vs pandemic
bull Terrorism-Bioterrorism vs explosion
15Northwest Center forPublic Health Practice
Legal and
Ethical Issues
16Northwest Center forPublic Health Practice
Questions
bull Do all professional ethical rules apply to mental health professionals during the chaos and confusion characteristic of the impact or heroic phase of a disaster
17Northwest Center forPublic Health Practice
CASE EXAMPLE
18Northwest Center forPublic Health Practice
You are working in a shelter after a hurricane and another mental health volunteer asks you to help her gather some survivors
together for a group CISD session She instructs you to go down the row of cots and select survivors particularly families with
children who appear upset and instruct them to assemble in a secluded corner of the gym where some chairs have been set
up The session is to begin in about an hour
What are the issues What should you do
19Northwest Center forPublic Health Practice
Issues
bull Standard of Practice At this juncture there really is no community standard
20Northwest Center forPublic Health Practice
NIMH Guidance(2002)
bull Early brief focused intervention can reduce stress
bull Selected cognitive behavioral approaches may help ASD PTSD amp depression
httpwwwnimhnihgovpublicatmassviolencepdf
21Northwest Center forPublic Health Practice
NIMH Guidance (2002)
bull Early intervention in form of recitals of events and emotions do not consistently help ie CISD is not necessarily helpful
bull No evidence that EMDR as an early intervention as treatment of choice over other practices
22Northwest Center forPublic Health Practice
APA Ethical RulesGuidelines for Psychologists
bull APA Ethical Rule sect 201 amp ASPPB Code of Conduct sect III (A) (4)
bull Psychologists provides services within the boundaries of their competence
bull In emerging areas psychologists nevertheless take reasonable steps to ensure competence
American Psychological Association Code of Ethics httpwwwapaorgethicscode2002html
23Northwest Center forPublic Health Practice
APA Rule- Emergency Provision
bull APA Ethical Rule sect 202
bull Psychologists may provide services for which they have not been trained in emergency situations- Would this rule apply to the disillusionment phase of a disaster (Days or weeks following a disaster)
24Northwest Center forPublic Health Practice
Analysis
bull Standard of Practice
bull So if there is none what is the Disaster Mental Health Professional supposed to do
25Northwest Center forPublic Health Practice
Recommended Guideline
ASPPB Code of Conduct III(A)(4)statesmdashrdquoengage in ongoing consultation amp inform clients of the innovative nature amp known risks of the servicerdquo
Association of State and Provincial Boards of Psychology Code of Conduct available at
httpwwwokgovOSBEPdocumentsASPPB_Code_of_Conduct_20055B15Dpdf
26Northwest Center forPublic Health Practice
Issues
bull Informed Consent
bull Itrsquos required but how do I get it
27Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull Psychologists must obtain informed consent before providing services
bull For persons who are legally incapable of giving informed consent (eg children) psychologists must obtain informed assent
Exemplar of Informed Assent Form for child mental health study Claremont Grad School httpwwwcgueduincludeInformed_AssentFormdoc
28Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull For services for which generally recognized techniques have yet not been established psychologists inform the client of the developing nature amp potential risks of the procedure
29Northwest Center forPublic Health Practice
Analysis
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sectIII (D) (1)
bull Informed consent includes discussion of nature amp course of treatment fees involvement of third parties limits to confidentiality and the provision of sufficient opportunity for the client to ask questions
30Northwest Center forPublic Health Practice
NCPTSD Guidance
bull Introduce yourself with your name and title and describe your role Ask permission to talk to them and explain your objective of finding out whether there is anything you can do to make things easier or helping with ways to help themselves feel betterhellipWhen making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission When speaking with a child in distress when no adult is present it is important to find a parent or caregiver to let them know about your role and seek permission
National Center for PTSD Guidance for mental health providers in acute phase httpwwwncptsdvagovncmainindexjsp
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
7Northwest Center forPublic Health Practice
You are working in a shelter after a hurricane and another mental health volunteer asks you to help her gather some
survivors together for a group CISD session She instructs you to go down the row of cots and select survivors
particularly families with children who appear upset and instruct them to assemble in a secluded corner of the gym
where some chairs have been set up The session is to begin in about an hour
What are the issues What should you do
8Northwest Center forPublic Health Practice
bull Provide practical legal amp ethical information for front-line post-disaster mental health researchers (and practitioners)
Purpose
9Northwest Center forPublic Health Practice
bull Appreciate the ethical and legal aspects of different phases and different types of disasters
bull Understand some of the legal amp ethical issues impacting both disaster mental health services and disaster mental health researchers
Goals
10Northwest Center forPublic Health Practice
Objectives
bull Develop competencies in recognizingbull Ethical issues involving standard of
practice informed consent confidentiality record keeping and supervision in the
provision of disaster mental health services
bull Legal issues involving professional liability licensure and HIPAA in the provision of disaster mental health services
11Northwest Center forPublic Health Practice
Objectives
bull Develop competencies in appreciatingbull The impact of statesrsquo disaster related statutes
on the provision of disaster mental health services amp research
bull The impact of federal statutes (eg HIPAA) when conducting disaster mental health research
bull The policies and guidelines that IRBs consider in approving human subject participation in disaster research
12Northwest Center forPublic Health Practice
Review Basic Disaster Concepts
bull Disasters have temporal phases
bull Disasters typology
The phase and type of disaster interact with legal and ethical parameters
13Northwest Center forPublic Health Practice
Psychosocial Phases of a Disaster
From Zunin amp Myers (2000)
14Northwest Center forPublic Health Practice
Types Of Disasters
bull Human made vs Natural disaster
bull Human made-neglect vs terrorism
bull Immediate vs Prolonged disaster
bull Natural-Hurricane vs pandemic
bull Terrorism-Bioterrorism vs explosion
15Northwest Center forPublic Health Practice
Legal and
Ethical Issues
16Northwest Center forPublic Health Practice
Questions
bull Do all professional ethical rules apply to mental health professionals during the chaos and confusion characteristic of the impact or heroic phase of a disaster
17Northwest Center forPublic Health Practice
CASE EXAMPLE
18Northwest Center forPublic Health Practice
You are working in a shelter after a hurricane and another mental health volunteer asks you to help her gather some survivors
together for a group CISD session She instructs you to go down the row of cots and select survivors particularly families with
children who appear upset and instruct them to assemble in a secluded corner of the gym where some chairs have been set
up The session is to begin in about an hour
What are the issues What should you do
19Northwest Center forPublic Health Practice
Issues
bull Standard of Practice At this juncture there really is no community standard
20Northwest Center forPublic Health Practice
NIMH Guidance(2002)
bull Early brief focused intervention can reduce stress
bull Selected cognitive behavioral approaches may help ASD PTSD amp depression
httpwwwnimhnihgovpublicatmassviolencepdf
21Northwest Center forPublic Health Practice
NIMH Guidance (2002)
bull Early intervention in form of recitals of events and emotions do not consistently help ie CISD is not necessarily helpful
bull No evidence that EMDR as an early intervention as treatment of choice over other practices
22Northwest Center forPublic Health Practice
APA Ethical RulesGuidelines for Psychologists
bull APA Ethical Rule sect 201 amp ASPPB Code of Conduct sect III (A) (4)
bull Psychologists provides services within the boundaries of their competence
bull In emerging areas psychologists nevertheless take reasonable steps to ensure competence
American Psychological Association Code of Ethics httpwwwapaorgethicscode2002html
23Northwest Center forPublic Health Practice
APA Rule- Emergency Provision
bull APA Ethical Rule sect 202
bull Psychologists may provide services for which they have not been trained in emergency situations- Would this rule apply to the disillusionment phase of a disaster (Days or weeks following a disaster)
24Northwest Center forPublic Health Practice
Analysis
bull Standard of Practice
bull So if there is none what is the Disaster Mental Health Professional supposed to do
25Northwest Center forPublic Health Practice
Recommended Guideline
ASPPB Code of Conduct III(A)(4)statesmdashrdquoengage in ongoing consultation amp inform clients of the innovative nature amp known risks of the servicerdquo
Association of State and Provincial Boards of Psychology Code of Conduct available at
httpwwwokgovOSBEPdocumentsASPPB_Code_of_Conduct_20055B15Dpdf
26Northwest Center forPublic Health Practice
Issues
bull Informed Consent
bull Itrsquos required but how do I get it
27Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull Psychologists must obtain informed consent before providing services
bull For persons who are legally incapable of giving informed consent (eg children) psychologists must obtain informed assent
Exemplar of Informed Assent Form for child mental health study Claremont Grad School httpwwwcgueduincludeInformed_AssentFormdoc
28Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull For services for which generally recognized techniques have yet not been established psychologists inform the client of the developing nature amp potential risks of the procedure
29Northwest Center forPublic Health Practice
Analysis
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sectIII (D) (1)
bull Informed consent includes discussion of nature amp course of treatment fees involvement of third parties limits to confidentiality and the provision of sufficient opportunity for the client to ask questions
30Northwest Center forPublic Health Practice
NCPTSD Guidance
bull Introduce yourself with your name and title and describe your role Ask permission to talk to them and explain your objective of finding out whether there is anything you can do to make things easier or helping with ways to help themselves feel betterhellipWhen making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission When speaking with a child in distress when no adult is present it is important to find a parent or caregiver to let them know about your role and seek permission
National Center for PTSD Guidance for mental health providers in acute phase httpwwwncptsdvagovncmainindexjsp
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
8Northwest Center forPublic Health Practice
bull Provide practical legal amp ethical information for front-line post-disaster mental health researchers (and practitioners)
Purpose
9Northwest Center forPublic Health Practice
bull Appreciate the ethical and legal aspects of different phases and different types of disasters
bull Understand some of the legal amp ethical issues impacting both disaster mental health services and disaster mental health researchers
Goals
10Northwest Center forPublic Health Practice
Objectives
bull Develop competencies in recognizingbull Ethical issues involving standard of
practice informed consent confidentiality record keeping and supervision in the
provision of disaster mental health services
bull Legal issues involving professional liability licensure and HIPAA in the provision of disaster mental health services
11Northwest Center forPublic Health Practice
Objectives
bull Develop competencies in appreciatingbull The impact of statesrsquo disaster related statutes
on the provision of disaster mental health services amp research
bull The impact of federal statutes (eg HIPAA) when conducting disaster mental health research
bull The policies and guidelines that IRBs consider in approving human subject participation in disaster research
12Northwest Center forPublic Health Practice
Review Basic Disaster Concepts
bull Disasters have temporal phases
bull Disasters typology
The phase and type of disaster interact with legal and ethical parameters
13Northwest Center forPublic Health Practice
Psychosocial Phases of a Disaster
From Zunin amp Myers (2000)
14Northwest Center forPublic Health Practice
Types Of Disasters
bull Human made vs Natural disaster
bull Human made-neglect vs terrorism
bull Immediate vs Prolonged disaster
bull Natural-Hurricane vs pandemic
bull Terrorism-Bioterrorism vs explosion
15Northwest Center forPublic Health Practice
Legal and
Ethical Issues
16Northwest Center forPublic Health Practice
Questions
bull Do all professional ethical rules apply to mental health professionals during the chaos and confusion characteristic of the impact or heroic phase of a disaster
17Northwest Center forPublic Health Practice
CASE EXAMPLE
18Northwest Center forPublic Health Practice
You are working in a shelter after a hurricane and another mental health volunteer asks you to help her gather some survivors
together for a group CISD session She instructs you to go down the row of cots and select survivors particularly families with
children who appear upset and instruct them to assemble in a secluded corner of the gym where some chairs have been set
up The session is to begin in about an hour
What are the issues What should you do
19Northwest Center forPublic Health Practice
Issues
bull Standard of Practice At this juncture there really is no community standard
20Northwest Center forPublic Health Practice
NIMH Guidance(2002)
bull Early brief focused intervention can reduce stress
bull Selected cognitive behavioral approaches may help ASD PTSD amp depression
httpwwwnimhnihgovpublicatmassviolencepdf
21Northwest Center forPublic Health Practice
NIMH Guidance (2002)
bull Early intervention in form of recitals of events and emotions do not consistently help ie CISD is not necessarily helpful
bull No evidence that EMDR as an early intervention as treatment of choice over other practices
22Northwest Center forPublic Health Practice
APA Ethical RulesGuidelines for Psychologists
bull APA Ethical Rule sect 201 amp ASPPB Code of Conduct sect III (A) (4)
bull Psychologists provides services within the boundaries of their competence
bull In emerging areas psychologists nevertheless take reasonable steps to ensure competence
American Psychological Association Code of Ethics httpwwwapaorgethicscode2002html
23Northwest Center forPublic Health Practice
APA Rule- Emergency Provision
bull APA Ethical Rule sect 202
bull Psychologists may provide services for which they have not been trained in emergency situations- Would this rule apply to the disillusionment phase of a disaster (Days or weeks following a disaster)
24Northwest Center forPublic Health Practice
Analysis
bull Standard of Practice
bull So if there is none what is the Disaster Mental Health Professional supposed to do
25Northwest Center forPublic Health Practice
Recommended Guideline
ASPPB Code of Conduct III(A)(4)statesmdashrdquoengage in ongoing consultation amp inform clients of the innovative nature amp known risks of the servicerdquo
Association of State and Provincial Boards of Psychology Code of Conduct available at
httpwwwokgovOSBEPdocumentsASPPB_Code_of_Conduct_20055B15Dpdf
26Northwest Center forPublic Health Practice
Issues
bull Informed Consent
bull Itrsquos required but how do I get it
27Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull Psychologists must obtain informed consent before providing services
bull For persons who are legally incapable of giving informed consent (eg children) psychologists must obtain informed assent
Exemplar of Informed Assent Form for child mental health study Claremont Grad School httpwwwcgueduincludeInformed_AssentFormdoc
28Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull For services for which generally recognized techniques have yet not been established psychologists inform the client of the developing nature amp potential risks of the procedure
29Northwest Center forPublic Health Practice
Analysis
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sectIII (D) (1)
bull Informed consent includes discussion of nature amp course of treatment fees involvement of third parties limits to confidentiality and the provision of sufficient opportunity for the client to ask questions
30Northwest Center forPublic Health Practice
NCPTSD Guidance
bull Introduce yourself with your name and title and describe your role Ask permission to talk to them and explain your objective of finding out whether there is anything you can do to make things easier or helping with ways to help themselves feel betterhellipWhen making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission When speaking with a child in distress when no adult is present it is important to find a parent or caregiver to let them know about your role and seek permission
National Center for PTSD Guidance for mental health providers in acute phase httpwwwncptsdvagovncmainindexjsp
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
9Northwest Center forPublic Health Practice
bull Appreciate the ethical and legal aspects of different phases and different types of disasters
bull Understand some of the legal amp ethical issues impacting both disaster mental health services and disaster mental health researchers
Goals
10Northwest Center forPublic Health Practice
Objectives
bull Develop competencies in recognizingbull Ethical issues involving standard of
practice informed consent confidentiality record keeping and supervision in the
provision of disaster mental health services
bull Legal issues involving professional liability licensure and HIPAA in the provision of disaster mental health services
11Northwest Center forPublic Health Practice
Objectives
bull Develop competencies in appreciatingbull The impact of statesrsquo disaster related statutes
on the provision of disaster mental health services amp research
bull The impact of federal statutes (eg HIPAA) when conducting disaster mental health research
bull The policies and guidelines that IRBs consider in approving human subject participation in disaster research
12Northwest Center forPublic Health Practice
Review Basic Disaster Concepts
bull Disasters have temporal phases
bull Disasters typology
The phase and type of disaster interact with legal and ethical parameters
13Northwest Center forPublic Health Practice
Psychosocial Phases of a Disaster
From Zunin amp Myers (2000)
14Northwest Center forPublic Health Practice
Types Of Disasters
bull Human made vs Natural disaster
bull Human made-neglect vs terrorism
bull Immediate vs Prolonged disaster
bull Natural-Hurricane vs pandemic
bull Terrorism-Bioterrorism vs explosion
15Northwest Center forPublic Health Practice
Legal and
Ethical Issues
16Northwest Center forPublic Health Practice
Questions
bull Do all professional ethical rules apply to mental health professionals during the chaos and confusion characteristic of the impact or heroic phase of a disaster
17Northwest Center forPublic Health Practice
CASE EXAMPLE
18Northwest Center forPublic Health Practice
You are working in a shelter after a hurricane and another mental health volunteer asks you to help her gather some survivors
together for a group CISD session She instructs you to go down the row of cots and select survivors particularly families with
children who appear upset and instruct them to assemble in a secluded corner of the gym where some chairs have been set
up The session is to begin in about an hour
What are the issues What should you do
19Northwest Center forPublic Health Practice
Issues
bull Standard of Practice At this juncture there really is no community standard
20Northwest Center forPublic Health Practice
NIMH Guidance(2002)
bull Early brief focused intervention can reduce stress
bull Selected cognitive behavioral approaches may help ASD PTSD amp depression
httpwwwnimhnihgovpublicatmassviolencepdf
21Northwest Center forPublic Health Practice
NIMH Guidance (2002)
bull Early intervention in form of recitals of events and emotions do not consistently help ie CISD is not necessarily helpful
bull No evidence that EMDR as an early intervention as treatment of choice over other practices
22Northwest Center forPublic Health Practice
APA Ethical RulesGuidelines for Psychologists
bull APA Ethical Rule sect 201 amp ASPPB Code of Conduct sect III (A) (4)
bull Psychologists provides services within the boundaries of their competence
bull In emerging areas psychologists nevertheless take reasonable steps to ensure competence
American Psychological Association Code of Ethics httpwwwapaorgethicscode2002html
23Northwest Center forPublic Health Practice
APA Rule- Emergency Provision
bull APA Ethical Rule sect 202
bull Psychologists may provide services for which they have not been trained in emergency situations- Would this rule apply to the disillusionment phase of a disaster (Days or weeks following a disaster)
24Northwest Center forPublic Health Practice
Analysis
bull Standard of Practice
bull So if there is none what is the Disaster Mental Health Professional supposed to do
25Northwest Center forPublic Health Practice
Recommended Guideline
ASPPB Code of Conduct III(A)(4)statesmdashrdquoengage in ongoing consultation amp inform clients of the innovative nature amp known risks of the servicerdquo
Association of State and Provincial Boards of Psychology Code of Conduct available at
httpwwwokgovOSBEPdocumentsASPPB_Code_of_Conduct_20055B15Dpdf
26Northwest Center forPublic Health Practice
Issues
bull Informed Consent
bull Itrsquos required but how do I get it
27Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull Psychologists must obtain informed consent before providing services
bull For persons who are legally incapable of giving informed consent (eg children) psychologists must obtain informed assent
Exemplar of Informed Assent Form for child mental health study Claremont Grad School httpwwwcgueduincludeInformed_AssentFormdoc
28Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull For services for which generally recognized techniques have yet not been established psychologists inform the client of the developing nature amp potential risks of the procedure
29Northwest Center forPublic Health Practice
Analysis
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sectIII (D) (1)
bull Informed consent includes discussion of nature amp course of treatment fees involvement of third parties limits to confidentiality and the provision of sufficient opportunity for the client to ask questions
30Northwest Center forPublic Health Practice
NCPTSD Guidance
bull Introduce yourself with your name and title and describe your role Ask permission to talk to them and explain your objective of finding out whether there is anything you can do to make things easier or helping with ways to help themselves feel betterhellipWhen making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission When speaking with a child in distress when no adult is present it is important to find a parent or caregiver to let them know about your role and seek permission
National Center for PTSD Guidance for mental health providers in acute phase httpwwwncptsdvagovncmainindexjsp
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
10Northwest Center forPublic Health Practice
Objectives
bull Develop competencies in recognizingbull Ethical issues involving standard of
practice informed consent confidentiality record keeping and supervision in the
provision of disaster mental health services
bull Legal issues involving professional liability licensure and HIPAA in the provision of disaster mental health services
11Northwest Center forPublic Health Practice
Objectives
bull Develop competencies in appreciatingbull The impact of statesrsquo disaster related statutes
on the provision of disaster mental health services amp research
bull The impact of federal statutes (eg HIPAA) when conducting disaster mental health research
bull The policies and guidelines that IRBs consider in approving human subject participation in disaster research
12Northwest Center forPublic Health Practice
Review Basic Disaster Concepts
bull Disasters have temporal phases
bull Disasters typology
The phase and type of disaster interact with legal and ethical parameters
13Northwest Center forPublic Health Practice
Psychosocial Phases of a Disaster
From Zunin amp Myers (2000)
14Northwest Center forPublic Health Practice
Types Of Disasters
bull Human made vs Natural disaster
bull Human made-neglect vs terrorism
bull Immediate vs Prolonged disaster
bull Natural-Hurricane vs pandemic
bull Terrorism-Bioterrorism vs explosion
15Northwest Center forPublic Health Practice
Legal and
Ethical Issues
16Northwest Center forPublic Health Practice
Questions
bull Do all professional ethical rules apply to mental health professionals during the chaos and confusion characteristic of the impact or heroic phase of a disaster
17Northwest Center forPublic Health Practice
CASE EXAMPLE
18Northwest Center forPublic Health Practice
You are working in a shelter after a hurricane and another mental health volunteer asks you to help her gather some survivors
together for a group CISD session She instructs you to go down the row of cots and select survivors particularly families with
children who appear upset and instruct them to assemble in a secluded corner of the gym where some chairs have been set
up The session is to begin in about an hour
What are the issues What should you do
19Northwest Center forPublic Health Practice
Issues
bull Standard of Practice At this juncture there really is no community standard
20Northwest Center forPublic Health Practice
NIMH Guidance(2002)
bull Early brief focused intervention can reduce stress
bull Selected cognitive behavioral approaches may help ASD PTSD amp depression
httpwwwnimhnihgovpublicatmassviolencepdf
21Northwest Center forPublic Health Practice
NIMH Guidance (2002)
bull Early intervention in form of recitals of events and emotions do not consistently help ie CISD is not necessarily helpful
bull No evidence that EMDR as an early intervention as treatment of choice over other practices
22Northwest Center forPublic Health Practice
APA Ethical RulesGuidelines for Psychologists
bull APA Ethical Rule sect 201 amp ASPPB Code of Conduct sect III (A) (4)
bull Psychologists provides services within the boundaries of their competence
bull In emerging areas psychologists nevertheless take reasonable steps to ensure competence
American Psychological Association Code of Ethics httpwwwapaorgethicscode2002html
23Northwest Center forPublic Health Practice
APA Rule- Emergency Provision
bull APA Ethical Rule sect 202
bull Psychologists may provide services for which they have not been trained in emergency situations- Would this rule apply to the disillusionment phase of a disaster (Days or weeks following a disaster)
24Northwest Center forPublic Health Practice
Analysis
bull Standard of Practice
bull So if there is none what is the Disaster Mental Health Professional supposed to do
25Northwest Center forPublic Health Practice
Recommended Guideline
ASPPB Code of Conduct III(A)(4)statesmdashrdquoengage in ongoing consultation amp inform clients of the innovative nature amp known risks of the servicerdquo
Association of State and Provincial Boards of Psychology Code of Conduct available at
httpwwwokgovOSBEPdocumentsASPPB_Code_of_Conduct_20055B15Dpdf
26Northwest Center forPublic Health Practice
Issues
bull Informed Consent
bull Itrsquos required but how do I get it
27Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull Psychologists must obtain informed consent before providing services
bull For persons who are legally incapable of giving informed consent (eg children) psychologists must obtain informed assent
Exemplar of Informed Assent Form for child mental health study Claremont Grad School httpwwwcgueduincludeInformed_AssentFormdoc
28Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull For services for which generally recognized techniques have yet not been established psychologists inform the client of the developing nature amp potential risks of the procedure
29Northwest Center forPublic Health Practice
Analysis
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sectIII (D) (1)
bull Informed consent includes discussion of nature amp course of treatment fees involvement of third parties limits to confidentiality and the provision of sufficient opportunity for the client to ask questions
30Northwest Center forPublic Health Practice
NCPTSD Guidance
bull Introduce yourself with your name and title and describe your role Ask permission to talk to them and explain your objective of finding out whether there is anything you can do to make things easier or helping with ways to help themselves feel betterhellipWhen making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission When speaking with a child in distress when no adult is present it is important to find a parent or caregiver to let them know about your role and seek permission
National Center for PTSD Guidance for mental health providers in acute phase httpwwwncptsdvagovncmainindexjsp
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
11Northwest Center forPublic Health Practice
Objectives
bull Develop competencies in appreciatingbull The impact of statesrsquo disaster related statutes
on the provision of disaster mental health services amp research
bull The impact of federal statutes (eg HIPAA) when conducting disaster mental health research
bull The policies and guidelines that IRBs consider in approving human subject participation in disaster research
12Northwest Center forPublic Health Practice
Review Basic Disaster Concepts
bull Disasters have temporal phases
bull Disasters typology
The phase and type of disaster interact with legal and ethical parameters
13Northwest Center forPublic Health Practice
Psychosocial Phases of a Disaster
From Zunin amp Myers (2000)
14Northwest Center forPublic Health Practice
Types Of Disasters
bull Human made vs Natural disaster
bull Human made-neglect vs terrorism
bull Immediate vs Prolonged disaster
bull Natural-Hurricane vs pandemic
bull Terrorism-Bioterrorism vs explosion
15Northwest Center forPublic Health Practice
Legal and
Ethical Issues
16Northwest Center forPublic Health Practice
Questions
bull Do all professional ethical rules apply to mental health professionals during the chaos and confusion characteristic of the impact or heroic phase of a disaster
17Northwest Center forPublic Health Practice
CASE EXAMPLE
18Northwest Center forPublic Health Practice
You are working in a shelter after a hurricane and another mental health volunteer asks you to help her gather some survivors
together for a group CISD session She instructs you to go down the row of cots and select survivors particularly families with
children who appear upset and instruct them to assemble in a secluded corner of the gym where some chairs have been set
up The session is to begin in about an hour
What are the issues What should you do
19Northwest Center forPublic Health Practice
Issues
bull Standard of Practice At this juncture there really is no community standard
20Northwest Center forPublic Health Practice
NIMH Guidance(2002)
bull Early brief focused intervention can reduce stress
bull Selected cognitive behavioral approaches may help ASD PTSD amp depression
httpwwwnimhnihgovpublicatmassviolencepdf
21Northwest Center forPublic Health Practice
NIMH Guidance (2002)
bull Early intervention in form of recitals of events and emotions do not consistently help ie CISD is not necessarily helpful
bull No evidence that EMDR as an early intervention as treatment of choice over other practices
22Northwest Center forPublic Health Practice
APA Ethical RulesGuidelines for Psychologists
bull APA Ethical Rule sect 201 amp ASPPB Code of Conduct sect III (A) (4)
bull Psychologists provides services within the boundaries of their competence
bull In emerging areas psychologists nevertheless take reasonable steps to ensure competence
American Psychological Association Code of Ethics httpwwwapaorgethicscode2002html
23Northwest Center forPublic Health Practice
APA Rule- Emergency Provision
bull APA Ethical Rule sect 202
bull Psychologists may provide services for which they have not been trained in emergency situations- Would this rule apply to the disillusionment phase of a disaster (Days or weeks following a disaster)
24Northwest Center forPublic Health Practice
Analysis
bull Standard of Practice
bull So if there is none what is the Disaster Mental Health Professional supposed to do
25Northwest Center forPublic Health Practice
Recommended Guideline
ASPPB Code of Conduct III(A)(4)statesmdashrdquoengage in ongoing consultation amp inform clients of the innovative nature amp known risks of the servicerdquo
Association of State and Provincial Boards of Psychology Code of Conduct available at
httpwwwokgovOSBEPdocumentsASPPB_Code_of_Conduct_20055B15Dpdf
26Northwest Center forPublic Health Practice
Issues
bull Informed Consent
bull Itrsquos required but how do I get it
27Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull Psychologists must obtain informed consent before providing services
bull For persons who are legally incapable of giving informed consent (eg children) psychologists must obtain informed assent
Exemplar of Informed Assent Form for child mental health study Claremont Grad School httpwwwcgueduincludeInformed_AssentFormdoc
28Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull For services for which generally recognized techniques have yet not been established psychologists inform the client of the developing nature amp potential risks of the procedure
29Northwest Center forPublic Health Practice
Analysis
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sectIII (D) (1)
bull Informed consent includes discussion of nature amp course of treatment fees involvement of third parties limits to confidentiality and the provision of sufficient opportunity for the client to ask questions
30Northwest Center forPublic Health Practice
NCPTSD Guidance
bull Introduce yourself with your name and title and describe your role Ask permission to talk to them and explain your objective of finding out whether there is anything you can do to make things easier or helping with ways to help themselves feel betterhellipWhen making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission When speaking with a child in distress when no adult is present it is important to find a parent or caregiver to let them know about your role and seek permission
National Center for PTSD Guidance for mental health providers in acute phase httpwwwncptsdvagovncmainindexjsp
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
12Northwest Center forPublic Health Practice
Review Basic Disaster Concepts
bull Disasters have temporal phases
bull Disasters typology
The phase and type of disaster interact with legal and ethical parameters
13Northwest Center forPublic Health Practice
Psychosocial Phases of a Disaster
From Zunin amp Myers (2000)
14Northwest Center forPublic Health Practice
Types Of Disasters
bull Human made vs Natural disaster
bull Human made-neglect vs terrorism
bull Immediate vs Prolonged disaster
bull Natural-Hurricane vs pandemic
bull Terrorism-Bioterrorism vs explosion
15Northwest Center forPublic Health Practice
Legal and
Ethical Issues
16Northwest Center forPublic Health Practice
Questions
bull Do all professional ethical rules apply to mental health professionals during the chaos and confusion characteristic of the impact or heroic phase of a disaster
17Northwest Center forPublic Health Practice
CASE EXAMPLE
18Northwest Center forPublic Health Practice
You are working in a shelter after a hurricane and another mental health volunteer asks you to help her gather some survivors
together for a group CISD session She instructs you to go down the row of cots and select survivors particularly families with
children who appear upset and instruct them to assemble in a secluded corner of the gym where some chairs have been set
up The session is to begin in about an hour
What are the issues What should you do
19Northwest Center forPublic Health Practice
Issues
bull Standard of Practice At this juncture there really is no community standard
20Northwest Center forPublic Health Practice
NIMH Guidance(2002)
bull Early brief focused intervention can reduce stress
bull Selected cognitive behavioral approaches may help ASD PTSD amp depression
httpwwwnimhnihgovpublicatmassviolencepdf
21Northwest Center forPublic Health Practice
NIMH Guidance (2002)
bull Early intervention in form of recitals of events and emotions do not consistently help ie CISD is not necessarily helpful
bull No evidence that EMDR as an early intervention as treatment of choice over other practices
22Northwest Center forPublic Health Practice
APA Ethical RulesGuidelines for Psychologists
bull APA Ethical Rule sect 201 amp ASPPB Code of Conduct sect III (A) (4)
bull Psychologists provides services within the boundaries of their competence
bull In emerging areas psychologists nevertheless take reasonable steps to ensure competence
American Psychological Association Code of Ethics httpwwwapaorgethicscode2002html
23Northwest Center forPublic Health Practice
APA Rule- Emergency Provision
bull APA Ethical Rule sect 202
bull Psychologists may provide services for which they have not been trained in emergency situations- Would this rule apply to the disillusionment phase of a disaster (Days or weeks following a disaster)
24Northwest Center forPublic Health Practice
Analysis
bull Standard of Practice
bull So if there is none what is the Disaster Mental Health Professional supposed to do
25Northwest Center forPublic Health Practice
Recommended Guideline
ASPPB Code of Conduct III(A)(4)statesmdashrdquoengage in ongoing consultation amp inform clients of the innovative nature amp known risks of the servicerdquo
Association of State and Provincial Boards of Psychology Code of Conduct available at
httpwwwokgovOSBEPdocumentsASPPB_Code_of_Conduct_20055B15Dpdf
26Northwest Center forPublic Health Practice
Issues
bull Informed Consent
bull Itrsquos required but how do I get it
27Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull Psychologists must obtain informed consent before providing services
bull For persons who are legally incapable of giving informed consent (eg children) psychologists must obtain informed assent
Exemplar of Informed Assent Form for child mental health study Claremont Grad School httpwwwcgueduincludeInformed_AssentFormdoc
28Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull For services for which generally recognized techniques have yet not been established psychologists inform the client of the developing nature amp potential risks of the procedure
29Northwest Center forPublic Health Practice
Analysis
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sectIII (D) (1)
bull Informed consent includes discussion of nature amp course of treatment fees involvement of third parties limits to confidentiality and the provision of sufficient opportunity for the client to ask questions
30Northwest Center forPublic Health Practice
NCPTSD Guidance
bull Introduce yourself with your name and title and describe your role Ask permission to talk to them and explain your objective of finding out whether there is anything you can do to make things easier or helping with ways to help themselves feel betterhellipWhen making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission When speaking with a child in distress when no adult is present it is important to find a parent or caregiver to let them know about your role and seek permission
National Center for PTSD Guidance for mental health providers in acute phase httpwwwncptsdvagovncmainindexjsp
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
13Northwest Center forPublic Health Practice
Psychosocial Phases of a Disaster
From Zunin amp Myers (2000)
14Northwest Center forPublic Health Practice
Types Of Disasters
bull Human made vs Natural disaster
bull Human made-neglect vs terrorism
bull Immediate vs Prolonged disaster
bull Natural-Hurricane vs pandemic
bull Terrorism-Bioterrorism vs explosion
15Northwest Center forPublic Health Practice
Legal and
Ethical Issues
16Northwest Center forPublic Health Practice
Questions
bull Do all professional ethical rules apply to mental health professionals during the chaos and confusion characteristic of the impact or heroic phase of a disaster
17Northwest Center forPublic Health Practice
CASE EXAMPLE
18Northwest Center forPublic Health Practice
You are working in a shelter after a hurricane and another mental health volunteer asks you to help her gather some survivors
together for a group CISD session She instructs you to go down the row of cots and select survivors particularly families with
children who appear upset and instruct them to assemble in a secluded corner of the gym where some chairs have been set
up The session is to begin in about an hour
What are the issues What should you do
19Northwest Center forPublic Health Practice
Issues
bull Standard of Practice At this juncture there really is no community standard
20Northwest Center forPublic Health Practice
NIMH Guidance(2002)
bull Early brief focused intervention can reduce stress
bull Selected cognitive behavioral approaches may help ASD PTSD amp depression
httpwwwnimhnihgovpublicatmassviolencepdf
21Northwest Center forPublic Health Practice
NIMH Guidance (2002)
bull Early intervention in form of recitals of events and emotions do not consistently help ie CISD is not necessarily helpful
bull No evidence that EMDR as an early intervention as treatment of choice over other practices
22Northwest Center forPublic Health Practice
APA Ethical RulesGuidelines for Psychologists
bull APA Ethical Rule sect 201 amp ASPPB Code of Conduct sect III (A) (4)
bull Psychologists provides services within the boundaries of their competence
bull In emerging areas psychologists nevertheless take reasonable steps to ensure competence
American Psychological Association Code of Ethics httpwwwapaorgethicscode2002html
23Northwest Center forPublic Health Practice
APA Rule- Emergency Provision
bull APA Ethical Rule sect 202
bull Psychologists may provide services for which they have not been trained in emergency situations- Would this rule apply to the disillusionment phase of a disaster (Days or weeks following a disaster)
24Northwest Center forPublic Health Practice
Analysis
bull Standard of Practice
bull So if there is none what is the Disaster Mental Health Professional supposed to do
25Northwest Center forPublic Health Practice
Recommended Guideline
ASPPB Code of Conduct III(A)(4)statesmdashrdquoengage in ongoing consultation amp inform clients of the innovative nature amp known risks of the servicerdquo
Association of State and Provincial Boards of Psychology Code of Conduct available at
httpwwwokgovOSBEPdocumentsASPPB_Code_of_Conduct_20055B15Dpdf
26Northwest Center forPublic Health Practice
Issues
bull Informed Consent
bull Itrsquos required but how do I get it
27Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull Psychologists must obtain informed consent before providing services
bull For persons who are legally incapable of giving informed consent (eg children) psychologists must obtain informed assent
Exemplar of Informed Assent Form for child mental health study Claremont Grad School httpwwwcgueduincludeInformed_AssentFormdoc
28Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull For services for which generally recognized techniques have yet not been established psychologists inform the client of the developing nature amp potential risks of the procedure
29Northwest Center forPublic Health Practice
Analysis
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sectIII (D) (1)
bull Informed consent includes discussion of nature amp course of treatment fees involvement of third parties limits to confidentiality and the provision of sufficient opportunity for the client to ask questions
30Northwest Center forPublic Health Practice
NCPTSD Guidance
bull Introduce yourself with your name and title and describe your role Ask permission to talk to them and explain your objective of finding out whether there is anything you can do to make things easier or helping with ways to help themselves feel betterhellipWhen making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission When speaking with a child in distress when no adult is present it is important to find a parent or caregiver to let them know about your role and seek permission
National Center for PTSD Guidance for mental health providers in acute phase httpwwwncptsdvagovncmainindexjsp
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
14Northwest Center forPublic Health Practice
Types Of Disasters
bull Human made vs Natural disaster
bull Human made-neglect vs terrorism
bull Immediate vs Prolonged disaster
bull Natural-Hurricane vs pandemic
bull Terrorism-Bioterrorism vs explosion
15Northwest Center forPublic Health Practice
Legal and
Ethical Issues
16Northwest Center forPublic Health Practice
Questions
bull Do all professional ethical rules apply to mental health professionals during the chaos and confusion characteristic of the impact or heroic phase of a disaster
17Northwest Center forPublic Health Practice
CASE EXAMPLE
18Northwest Center forPublic Health Practice
You are working in a shelter after a hurricane and another mental health volunteer asks you to help her gather some survivors
together for a group CISD session She instructs you to go down the row of cots and select survivors particularly families with
children who appear upset and instruct them to assemble in a secluded corner of the gym where some chairs have been set
up The session is to begin in about an hour
What are the issues What should you do
19Northwest Center forPublic Health Practice
Issues
bull Standard of Practice At this juncture there really is no community standard
20Northwest Center forPublic Health Practice
NIMH Guidance(2002)
bull Early brief focused intervention can reduce stress
bull Selected cognitive behavioral approaches may help ASD PTSD amp depression
httpwwwnimhnihgovpublicatmassviolencepdf
21Northwest Center forPublic Health Practice
NIMH Guidance (2002)
bull Early intervention in form of recitals of events and emotions do not consistently help ie CISD is not necessarily helpful
bull No evidence that EMDR as an early intervention as treatment of choice over other practices
22Northwest Center forPublic Health Practice
APA Ethical RulesGuidelines for Psychologists
bull APA Ethical Rule sect 201 amp ASPPB Code of Conduct sect III (A) (4)
bull Psychologists provides services within the boundaries of their competence
bull In emerging areas psychologists nevertheless take reasonable steps to ensure competence
American Psychological Association Code of Ethics httpwwwapaorgethicscode2002html
23Northwest Center forPublic Health Practice
APA Rule- Emergency Provision
bull APA Ethical Rule sect 202
bull Psychologists may provide services for which they have not been trained in emergency situations- Would this rule apply to the disillusionment phase of a disaster (Days or weeks following a disaster)
24Northwest Center forPublic Health Practice
Analysis
bull Standard of Practice
bull So if there is none what is the Disaster Mental Health Professional supposed to do
25Northwest Center forPublic Health Practice
Recommended Guideline
ASPPB Code of Conduct III(A)(4)statesmdashrdquoengage in ongoing consultation amp inform clients of the innovative nature amp known risks of the servicerdquo
Association of State and Provincial Boards of Psychology Code of Conduct available at
httpwwwokgovOSBEPdocumentsASPPB_Code_of_Conduct_20055B15Dpdf
26Northwest Center forPublic Health Practice
Issues
bull Informed Consent
bull Itrsquos required but how do I get it
27Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull Psychologists must obtain informed consent before providing services
bull For persons who are legally incapable of giving informed consent (eg children) psychologists must obtain informed assent
Exemplar of Informed Assent Form for child mental health study Claremont Grad School httpwwwcgueduincludeInformed_AssentFormdoc
28Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull For services for which generally recognized techniques have yet not been established psychologists inform the client of the developing nature amp potential risks of the procedure
29Northwest Center forPublic Health Practice
Analysis
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sectIII (D) (1)
bull Informed consent includes discussion of nature amp course of treatment fees involvement of third parties limits to confidentiality and the provision of sufficient opportunity for the client to ask questions
30Northwest Center forPublic Health Practice
NCPTSD Guidance
bull Introduce yourself with your name and title and describe your role Ask permission to talk to them and explain your objective of finding out whether there is anything you can do to make things easier or helping with ways to help themselves feel betterhellipWhen making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission When speaking with a child in distress when no adult is present it is important to find a parent or caregiver to let them know about your role and seek permission
National Center for PTSD Guidance for mental health providers in acute phase httpwwwncptsdvagovncmainindexjsp
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
15Northwest Center forPublic Health Practice
Legal and
Ethical Issues
16Northwest Center forPublic Health Practice
Questions
bull Do all professional ethical rules apply to mental health professionals during the chaos and confusion characteristic of the impact or heroic phase of a disaster
17Northwest Center forPublic Health Practice
CASE EXAMPLE
18Northwest Center forPublic Health Practice
You are working in a shelter after a hurricane and another mental health volunteer asks you to help her gather some survivors
together for a group CISD session She instructs you to go down the row of cots and select survivors particularly families with
children who appear upset and instruct them to assemble in a secluded corner of the gym where some chairs have been set
up The session is to begin in about an hour
What are the issues What should you do
19Northwest Center forPublic Health Practice
Issues
bull Standard of Practice At this juncture there really is no community standard
20Northwest Center forPublic Health Practice
NIMH Guidance(2002)
bull Early brief focused intervention can reduce stress
bull Selected cognitive behavioral approaches may help ASD PTSD amp depression
httpwwwnimhnihgovpublicatmassviolencepdf
21Northwest Center forPublic Health Practice
NIMH Guidance (2002)
bull Early intervention in form of recitals of events and emotions do not consistently help ie CISD is not necessarily helpful
bull No evidence that EMDR as an early intervention as treatment of choice over other practices
22Northwest Center forPublic Health Practice
APA Ethical RulesGuidelines for Psychologists
bull APA Ethical Rule sect 201 amp ASPPB Code of Conduct sect III (A) (4)
bull Psychologists provides services within the boundaries of their competence
bull In emerging areas psychologists nevertheless take reasonable steps to ensure competence
American Psychological Association Code of Ethics httpwwwapaorgethicscode2002html
23Northwest Center forPublic Health Practice
APA Rule- Emergency Provision
bull APA Ethical Rule sect 202
bull Psychologists may provide services for which they have not been trained in emergency situations- Would this rule apply to the disillusionment phase of a disaster (Days or weeks following a disaster)
24Northwest Center forPublic Health Practice
Analysis
bull Standard of Practice
bull So if there is none what is the Disaster Mental Health Professional supposed to do
25Northwest Center forPublic Health Practice
Recommended Guideline
ASPPB Code of Conduct III(A)(4)statesmdashrdquoengage in ongoing consultation amp inform clients of the innovative nature amp known risks of the servicerdquo
Association of State and Provincial Boards of Psychology Code of Conduct available at
httpwwwokgovOSBEPdocumentsASPPB_Code_of_Conduct_20055B15Dpdf
26Northwest Center forPublic Health Practice
Issues
bull Informed Consent
bull Itrsquos required but how do I get it
27Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull Psychologists must obtain informed consent before providing services
bull For persons who are legally incapable of giving informed consent (eg children) psychologists must obtain informed assent
Exemplar of Informed Assent Form for child mental health study Claremont Grad School httpwwwcgueduincludeInformed_AssentFormdoc
28Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull For services for which generally recognized techniques have yet not been established psychologists inform the client of the developing nature amp potential risks of the procedure
29Northwest Center forPublic Health Practice
Analysis
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sectIII (D) (1)
bull Informed consent includes discussion of nature amp course of treatment fees involvement of third parties limits to confidentiality and the provision of sufficient opportunity for the client to ask questions
30Northwest Center forPublic Health Practice
NCPTSD Guidance
bull Introduce yourself with your name and title and describe your role Ask permission to talk to them and explain your objective of finding out whether there is anything you can do to make things easier or helping with ways to help themselves feel betterhellipWhen making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission When speaking with a child in distress when no adult is present it is important to find a parent or caregiver to let them know about your role and seek permission
National Center for PTSD Guidance for mental health providers in acute phase httpwwwncptsdvagovncmainindexjsp
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
16Northwest Center forPublic Health Practice
Questions
bull Do all professional ethical rules apply to mental health professionals during the chaos and confusion characteristic of the impact or heroic phase of a disaster
17Northwest Center forPublic Health Practice
CASE EXAMPLE
18Northwest Center forPublic Health Practice
You are working in a shelter after a hurricane and another mental health volunteer asks you to help her gather some survivors
together for a group CISD session She instructs you to go down the row of cots and select survivors particularly families with
children who appear upset and instruct them to assemble in a secluded corner of the gym where some chairs have been set
up The session is to begin in about an hour
What are the issues What should you do
19Northwest Center forPublic Health Practice
Issues
bull Standard of Practice At this juncture there really is no community standard
20Northwest Center forPublic Health Practice
NIMH Guidance(2002)
bull Early brief focused intervention can reduce stress
bull Selected cognitive behavioral approaches may help ASD PTSD amp depression
httpwwwnimhnihgovpublicatmassviolencepdf
21Northwest Center forPublic Health Practice
NIMH Guidance (2002)
bull Early intervention in form of recitals of events and emotions do not consistently help ie CISD is not necessarily helpful
bull No evidence that EMDR as an early intervention as treatment of choice over other practices
22Northwest Center forPublic Health Practice
APA Ethical RulesGuidelines for Psychologists
bull APA Ethical Rule sect 201 amp ASPPB Code of Conduct sect III (A) (4)
bull Psychologists provides services within the boundaries of their competence
bull In emerging areas psychologists nevertheless take reasonable steps to ensure competence
American Psychological Association Code of Ethics httpwwwapaorgethicscode2002html
23Northwest Center forPublic Health Practice
APA Rule- Emergency Provision
bull APA Ethical Rule sect 202
bull Psychologists may provide services for which they have not been trained in emergency situations- Would this rule apply to the disillusionment phase of a disaster (Days or weeks following a disaster)
24Northwest Center forPublic Health Practice
Analysis
bull Standard of Practice
bull So if there is none what is the Disaster Mental Health Professional supposed to do
25Northwest Center forPublic Health Practice
Recommended Guideline
ASPPB Code of Conduct III(A)(4)statesmdashrdquoengage in ongoing consultation amp inform clients of the innovative nature amp known risks of the servicerdquo
Association of State and Provincial Boards of Psychology Code of Conduct available at
httpwwwokgovOSBEPdocumentsASPPB_Code_of_Conduct_20055B15Dpdf
26Northwest Center forPublic Health Practice
Issues
bull Informed Consent
bull Itrsquos required but how do I get it
27Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull Psychologists must obtain informed consent before providing services
bull For persons who are legally incapable of giving informed consent (eg children) psychologists must obtain informed assent
Exemplar of Informed Assent Form for child mental health study Claremont Grad School httpwwwcgueduincludeInformed_AssentFormdoc
28Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull For services for which generally recognized techniques have yet not been established psychologists inform the client of the developing nature amp potential risks of the procedure
29Northwest Center forPublic Health Practice
Analysis
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sectIII (D) (1)
bull Informed consent includes discussion of nature amp course of treatment fees involvement of third parties limits to confidentiality and the provision of sufficient opportunity for the client to ask questions
30Northwest Center forPublic Health Practice
NCPTSD Guidance
bull Introduce yourself with your name and title and describe your role Ask permission to talk to them and explain your objective of finding out whether there is anything you can do to make things easier or helping with ways to help themselves feel betterhellipWhen making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission When speaking with a child in distress when no adult is present it is important to find a parent or caregiver to let them know about your role and seek permission
National Center for PTSD Guidance for mental health providers in acute phase httpwwwncptsdvagovncmainindexjsp
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
17Northwest Center forPublic Health Practice
CASE EXAMPLE
18Northwest Center forPublic Health Practice
You are working in a shelter after a hurricane and another mental health volunteer asks you to help her gather some survivors
together for a group CISD session She instructs you to go down the row of cots and select survivors particularly families with
children who appear upset and instruct them to assemble in a secluded corner of the gym where some chairs have been set
up The session is to begin in about an hour
What are the issues What should you do
19Northwest Center forPublic Health Practice
Issues
bull Standard of Practice At this juncture there really is no community standard
20Northwest Center forPublic Health Practice
NIMH Guidance(2002)
bull Early brief focused intervention can reduce stress
bull Selected cognitive behavioral approaches may help ASD PTSD amp depression
httpwwwnimhnihgovpublicatmassviolencepdf
21Northwest Center forPublic Health Practice
NIMH Guidance (2002)
bull Early intervention in form of recitals of events and emotions do not consistently help ie CISD is not necessarily helpful
bull No evidence that EMDR as an early intervention as treatment of choice over other practices
22Northwest Center forPublic Health Practice
APA Ethical RulesGuidelines for Psychologists
bull APA Ethical Rule sect 201 amp ASPPB Code of Conduct sect III (A) (4)
bull Psychologists provides services within the boundaries of their competence
bull In emerging areas psychologists nevertheless take reasonable steps to ensure competence
American Psychological Association Code of Ethics httpwwwapaorgethicscode2002html
23Northwest Center forPublic Health Practice
APA Rule- Emergency Provision
bull APA Ethical Rule sect 202
bull Psychologists may provide services for which they have not been trained in emergency situations- Would this rule apply to the disillusionment phase of a disaster (Days or weeks following a disaster)
24Northwest Center forPublic Health Practice
Analysis
bull Standard of Practice
bull So if there is none what is the Disaster Mental Health Professional supposed to do
25Northwest Center forPublic Health Practice
Recommended Guideline
ASPPB Code of Conduct III(A)(4)statesmdashrdquoengage in ongoing consultation amp inform clients of the innovative nature amp known risks of the servicerdquo
Association of State and Provincial Boards of Psychology Code of Conduct available at
httpwwwokgovOSBEPdocumentsASPPB_Code_of_Conduct_20055B15Dpdf
26Northwest Center forPublic Health Practice
Issues
bull Informed Consent
bull Itrsquos required but how do I get it
27Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull Psychologists must obtain informed consent before providing services
bull For persons who are legally incapable of giving informed consent (eg children) psychologists must obtain informed assent
Exemplar of Informed Assent Form for child mental health study Claremont Grad School httpwwwcgueduincludeInformed_AssentFormdoc
28Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull For services for which generally recognized techniques have yet not been established psychologists inform the client of the developing nature amp potential risks of the procedure
29Northwest Center forPublic Health Practice
Analysis
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sectIII (D) (1)
bull Informed consent includes discussion of nature amp course of treatment fees involvement of third parties limits to confidentiality and the provision of sufficient opportunity for the client to ask questions
30Northwest Center forPublic Health Practice
NCPTSD Guidance
bull Introduce yourself with your name and title and describe your role Ask permission to talk to them and explain your objective of finding out whether there is anything you can do to make things easier or helping with ways to help themselves feel betterhellipWhen making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission When speaking with a child in distress when no adult is present it is important to find a parent or caregiver to let them know about your role and seek permission
National Center for PTSD Guidance for mental health providers in acute phase httpwwwncptsdvagovncmainindexjsp
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
18Northwest Center forPublic Health Practice
You are working in a shelter after a hurricane and another mental health volunteer asks you to help her gather some survivors
together for a group CISD session She instructs you to go down the row of cots and select survivors particularly families with
children who appear upset and instruct them to assemble in a secluded corner of the gym where some chairs have been set
up The session is to begin in about an hour
What are the issues What should you do
19Northwest Center forPublic Health Practice
Issues
bull Standard of Practice At this juncture there really is no community standard
20Northwest Center forPublic Health Practice
NIMH Guidance(2002)
bull Early brief focused intervention can reduce stress
bull Selected cognitive behavioral approaches may help ASD PTSD amp depression
httpwwwnimhnihgovpublicatmassviolencepdf
21Northwest Center forPublic Health Practice
NIMH Guidance (2002)
bull Early intervention in form of recitals of events and emotions do not consistently help ie CISD is not necessarily helpful
bull No evidence that EMDR as an early intervention as treatment of choice over other practices
22Northwest Center forPublic Health Practice
APA Ethical RulesGuidelines for Psychologists
bull APA Ethical Rule sect 201 amp ASPPB Code of Conduct sect III (A) (4)
bull Psychologists provides services within the boundaries of their competence
bull In emerging areas psychologists nevertheless take reasonable steps to ensure competence
American Psychological Association Code of Ethics httpwwwapaorgethicscode2002html
23Northwest Center forPublic Health Practice
APA Rule- Emergency Provision
bull APA Ethical Rule sect 202
bull Psychologists may provide services for which they have not been trained in emergency situations- Would this rule apply to the disillusionment phase of a disaster (Days or weeks following a disaster)
24Northwest Center forPublic Health Practice
Analysis
bull Standard of Practice
bull So if there is none what is the Disaster Mental Health Professional supposed to do
25Northwest Center forPublic Health Practice
Recommended Guideline
ASPPB Code of Conduct III(A)(4)statesmdashrdquoengage in ongoing consultation amp inform clients of the innovative nature amp known risks of the servicerdquo
Association of State and Provincial Boards of Psychology Code of Conduct available at
httpwwwokgovOSBEPdocumentsASPPB_Code_of_Conduct_20055B15Dpdf
26Northwest Center forPublic Health Practice
Issues
bull Informed Consent
bull Itrsquos required but how do I get it
27Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull Psychologists must obtain informed consent before providing services
bull For persons who are legally incapable of giving informed consent (eg children) psychologists must obtain informed assent
Exemplar of Informed Assent Form for child mental health study Claremont Grad School httpwwwcgueduincludeInformed_AssentFormdoc
28Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull For services for which generally recognized techniques have yet not been established psychologists inform the client of the developing nature amp potential risks of the procedure
29Northwest Center forPublic Health Practice
Analysis
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sectIII (D) (1)
bull Informed consent includes discussion of nature amp course of treatment fees involvement of third parties limits to confidentiality and the provision of sufficient opportunity for the client to ask questions
30Northwest Center forPublic Health Practice
NCPTSD Guidance
bull Introduce yourself with your name and title and describe your role Ask permission to talk to them and explain your objective of finding out whether there is anything you can do to make things easier or helping with ways to help themselves feel betterhellipWhen making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission When speaking with a child in distress when no adult is present it is important to find a parent or caregiver to let them know about your role and seek permission
National Center for PTSD Guidance for mental health providers in acute phase httpwwwncptsdvagovncmainindexjsp
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
19Northwest Center forPublic Health Practice
Issues
bull Standard of Practice At this juncture there really is no community standard
20Northwest Center forPublic Health Practice
NIMH Guidance(2002)
bull Early brief focused intervention can reduce stress
bull Selected cognitive behavioral approaches may help ASD PTSD amp depression
httpwwwnimhnihgovpublicatmassviolencepdf
21Northwest Center forPublic Health Practice
NIMH Guidance (2002)
bull Early intervention in form of recitals of events and emotions do not consistently help ie CISD is not necessarily helpful
bull No evidence that EMDR as an early intervention as treatment of choice over other practices
22Northwest Center forPublic Health Practice
APA Ethical RulesGuidelines for Psychologists
bull APA Ethical Rule sect 201 amp ASPPB Code of Conduct sect III (A) (4)
bull Psychologists provides services within the boundaries of their competence
bull In emerging areas psychologists nevertheless take reasonable steps to ensure competence
American Psychological Association Code of Ethics httpwwwapaorgethicscode2002html
23Northwest Center forPublic Health Practice
APA Rule- Emergency Provision
bull APA Ethical Rule sect 202
bull Psychologists may provide services for which they have not been trained in emergency situations- Would this rule apply to the disillusionment phase of a disaster (Days or weeks following a disaster)
24Northwest Center forPublic Health Practice
Analysis
bull Standard of Practice
bull So if there is none what is the Disaster Mental Health Professional supposed to do
25Northwest Center forPublic Health Practice
Recommended Guideline
ASPPB Code of Conduct III(A)(4)statesmdashrdquoengage in ongoing consultation amp inform clients of the innovative nature amp known risks of the servicerdquo
Association of State and Provincial Boards of Psychology Code of Conduct available at
httpwwwokgovOSBEPdocumentsASPPB_Code_of_Conduct_20055B15Dpdf
26Northwest Center forPublic Health Practice
Issues
bull Informed Consent
bull Itrsquos required but how do I get it
27Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull Psychologists must obtain informed consent before providing services
bull For persons who are legally incapable of giving informed consent (eg children) psychologists must obtain informed assent
Exemplar of Informed Assent Form for child mental health study Claremont Grad School httpwwwcgueduincludeInformed_AssentFormdoc
28Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull For services for which generally recognized techniques have yet not been established psychologists inform the client of the developing nature amp potential risks of the procedure
29Northwest Center forPublic Health Practice
Analysis
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sectIII (D) (1)
bull Informed consent includes discussion of nature amp course of treatment fees involvement of third parties limits to confidentiality and the provision of sufficient opportunity for the client to ask questions
30Northwest Center forPublic Health Practice
NCPTSD Guidance
bull Introduce yourself with your name and title and describe your role Ask permission to talk to them and explain your objective of finding out whether there is anything you can do to make things easier or helping with ways to help themselves feel betterhellipWhen making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission When speaking with a child in distress when no adult is present it is important to find a parent or caregiver to let them know about your role and seek permission
National Center for PTSD Guidance for mental health providers in acute phase httpwwwncptsdvagovncmainindexjsp
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
20Northwest Center forPublic Health Practice
NIMH Guidance(2002)
bull Early brief focused intervention can reduce stress
bull Selected cognitive behavioral approaches may help ASD PTSD amp depression
httpwwwnimhnihgovpublicatmassviolencepdf
21Northwest Center forPublic Health Practice
NIMH Guidance (2002)
bull Early intervention in form of recitals of events and emotions do not consistently help ie CISD is not necessarily helpful
bull No evidence that EMDR as an early intervention as treatment of choice over other practices
22Northwest Center forPublic Health Practice
APA Ethical RulesGuidelines for Psychologists
bull APA Ethical Rule sect 201 amp ASPPB Code of Conduct sect III (A) (4)
bull Psychologists provides services within the boundaries of their competence
bull In emerging areas psychologists nevertheless take reasonable steps to ensure competence
American Psychological Association Code of Ethics httpwwwapaorgethicscode2002html
23Northwest Center forPublic Health Practice
APA Rule- Emergency Provision
bull APA Ethical Rule sect 202
bull Psychologists may provide services for which they have not been trained in emergency situations- Would this rule apply to the disillusionment phase of a disaster (Days or weeks following a disaster)
24Northwest Center forPublic Health Practice
Analysis
bull Standard of Practice
bull So if there is none what is the Disaster Mental Health Professional supposed to do
25Northwest Center forPublic Health Practice
Recommended Guideline
ASPPB Code of Conduct III(A)(4)statesmdashrdquoengage in ongoing consultation amp inform clients of the innovative nature amp known risks of the servicerdquo
Association of State and Provincial Boards of Psychology Code of Conduct available at
httpwwwokgovOSBEPdocumentsASPPB_Code_of_Conduct_20055B15Dpdf
26Northwest Center forPublic Health Practice
Issues
bull Informed Consent
bull Itrsquos required but how do I get it
27Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull Psychologists must obtain informed consent before providing services
bull For persons who are legally incapable of giving informed consent (eg children) psychologists must obtain informed assent
Exemplar of Informed Assent Form for child mental health study Claremont Grad School httpwwwcgueduincludeInformed_AssentFormdoc
28Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull For services for which generally recognized techniques have yet not been established psychologists inform the client of the developing nature amp potential risks of the procedure
29Northwest Center forPublic Health Practice
Analysis
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sectIII (D) (1)
bull Informed consent includes discussion of nature amp course of treatment fees involvement of third parties limits to confidentiality and the provision of sufficient opportunity for the client to ask questions
30Northwest Center forPublic Health Practice
NCPTSD Guidance
bull Introduce yourself with your name and title and describe your role Ask permission to talk to them and explain your objective of finding out whether there is anything you can do to make things easier or helping with ways to help themselves feel betterhellipWhen making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission When speaking with a child in distress when no adult is present it is important to find a parent or caregiver to let them know about your role and seek permission
National Center for PTSD Guidance for mental health providers in acute phase httpwwwncptsdvagovncmainindexjsp
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
21Northwest Center forPublic Health Practice
NIMH Guidance (2002)
bull Early intervention in form of recitals of events and emotions do not consistently help ie CISD is not necessarily helpful
bull No evidence that EMDR as an early intervention as treatment of choice over other practices
22Northwest Center forPublic Health Practice
APA Ethical RulesGuidelines for Psychologists
bull APA Ethical Rule sect 201 amp ASPPB Code of Conduct sect III (A) (4)
bull Psychologists provides services within the boundaries of their competence
bull In emerging areas psychologists nevertheless take reasonable steps to ensure competence
American Psychological Association Code of Ethics httpwwwapaorgethicscode2002html
23Northwest Center forPublic Health Practice
APA Rule- Emergency Provision
bull APA Ethical Rule sect 202
bull Psychologists may provide services for which they have not been trained in emergency situations- Would this rule apply to the disillusionment phase of a disaster (Days or weeks following a disaster)
24Northwest Center forPublic Health Practice
Analysis
bull Standard of Practice
bull So if there is none what is the Disaster Mental Health Professional supposed to do
25Northwest Center forPublic Health Practice
Recommended Guideline
ASPPB Code of Conduct III(A)(4)statesmdashrdquoengage in ongoing consultation amp inform clients of the innovative nature amp known risks of the servicerdquo
Association of State and Provincial Boards of Psychology Code of Conduct available at
httpwwwokgovOSBEPdocumentsASPPB_Code_of_Conduct_20055B15Dpdf
26Northwest Center forPublic Health Practice
Issues
bull Informed Consent
bull Itrsquos required but how do I get it
27Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull Psychologists must obtain informed consent before providing services
bull For persons who are legally incapable of giving informed consent (eg children) psychologists must obtain informed assent
Exemplar of Informed Assent Form for child mental health study Claremont Grad School httpwwwcgueduincludeInformed_AssentFormdoc
28Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull For services for which generally recognized techniques have yet not been established psychologists inform the client of the developing nature amp potential risks of the procedure
29Northwest Center forPublic Health Practice
Analysis
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sectIII (D) (1)
bull Informed consent includes discussion of nature amp course of treatment fees involvement of third parties limits to confidentiality and the provision of sufficient opportunity for the client to ask questions
30Northwest Center forPublic Health Practice
NCPTSD Guidance
bull Introduce yourself with your name and title and describe your role Ask permission to talk to them and explain your objective of finding out whether there is anything you can do to make things easier or helping with ways to help themselves feel betterhellipWhen making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission When speaking with a child in distress when no adult is present it is important to find a parent or caregiver to let them know about your role and seek permission
National Center for PTSD Guidance for mental health providers in acute phase httpwwwncptsdvagovncmainindexjsp
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
22Northwest Center forPublic Health Practice
APA Ethical RulesGuidelines for Psychologists
bull APA Ethical Rule sect 201 amp ASPPB Code of Conduct sect III (A) (4)
bull Psychologists provides services within the boundaries of their competence
bull In emerging areas psychologists nevertheless take reasonable steps to ensure competence
American Psychological Association Code of Ethics httpwwwapaorgethicscode2002html
23Northwest Center forPublic Health Practice
APA Rule- Emergency Provision
bull APA Ethical Rule sect 202
bull Psychologists may provide services for which they have not been trained in emergency situations- Would this rule apply to the disillusionment phase of a disaster (Days or weeks following a disaster)
24Northwest Center forPublic Health Practice
Analysis
bull Standard of Practice
bull So if there is none what is the Disaster Mental Health Professional supposed to do
25Northwest Center forPublic Health Practice
Recommended Guideline
ASPPB Code of Conduct III(A)(4)statesmdashrdquoengage in ongoing consultation amp inform clients of the innovative nature amp known risks of the servicerdquo
Association of State and Provincial Boards of Psychology Code of Conduct available at
httpwwwokgovOSBEPdocumentsASPPB_Code_of_Conduct_20055B15Dpdf
26Northwest Center forPublic Health Practice
Issues
bull Informed Consent
bull Itrsquos required but how do I get it
27Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull Psychologists must obtain informed consent before providing services
bull For persons who are legally incapable of giving informed consent (eg children) psychologists must obtain informed assent
Exemplar of Informed Assent Form for child mental health study Claremont Grad School httpwwwcgueduincludeInformed_AssentFormdoc
28Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull For services for which generally recognized techniques have yet not been established psychologists inform the client of the developing nature amp potential risks of the procedure
29Northwest Center forPublic Health Practice
Analysis
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sectIII (D) (1)
bull Informed consent includes discussion of nature amp course of treatment fees involvement of third parties limits to confidentiality and the provision of sufficient opportunity for the client to ask questions
30Northwest Center forPublic Health Practice
NCPTSD Guidance
bull Introduce yourself with your name and title and describe your role Ask permission to talk to them and explain your objective of finding out whether there is anything you can do to make things easier or helping with ways to help themselves feel betterhellipWhen making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission When speaking with a child in distress when no adult is present it is important to find a parent or caregiver to let them know about your role and seek permission
National Center for PTSD Guidance for mental health providers in acute phase httpwwwncptsdvagovncmainindexjsp
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
23Northwest Center forPublic Health Practice
APA Rule- Emergency Provision
bull APA Ethical Rule sect 202
bull Psychologists may provide services for which they have not been trained in emergency situations- Would this rule apply to the disillusionment phase of a disaster (Days or weeks following a disaster)
24Northwest Center forPublic Health Practice
Analysis
bull Standard of Practice
bull So if there is none what is the Disaster Mental Health Professional supposed to do
25Northwest Center forPublic Health Practice
Recommended Guideline
ASPPB Code of Conduct III(A)(4)statesmdashrdquoengage in ongoing consultation amp inform clients of the innovative nature amp known risks of the servicerdquo
Association of State and Provincial Boards of Psychology Code of Conduct available at
httpwwwokgovOSBEPdocumentsASPPB_Code_of_Conduct_20055B15Dpdf
26Northwest Center forPublic Health Practice
Issues
bull Informed Consent
bull Itrsquos required but how do I get it
27Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull Psychologists must obtain informed consent before providing services
bull For persons who are legally incapable of giving informed consent (eg children) psychologists must obtain informed assent
Exemplar of Informed Assent Form for child mental health study Claremont Grad School httpwwwcgueduincludeInformed_AssentFormdoc
28Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull For services for which generally recognized techniques have yet not been established psychologists inform the client of the developing nature amp potential risks of the procedure
29Northwest Center forPublic Health Practice
Analysis
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sectIII (D) (1)
bull Informed consent includes discussion of nature amp course of treatment fees involvement of third parties limits to confidentiality and the provision of sufficient opportunity for the client to ask questions
30Northwest Center forPublic Health Practice
NCPTSD Guidance
bull Introduce yourself with your name and title and describe your role Ask permission to talk to them and explain your objective of finding out whether there is anything you can do to make things easier or helping with ways to help themselves feel betterhellipWhen making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission When speaking with a child in distress when no adult is present it is important to find a parent or caregiver to let them know about your role and seek permission
National Center for PTSD Guidance for mental health providers in acute phase httpwwwncptsdvagovncmainindexjsp
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
24Northwest Center forPublic Health Practice
Analysis
bull Standard of Practice
bull So if there is none what is the Disaster Mental Health Professional supposed to do
25Northwest Center forPublic Health Practice
Recommended Guideline
ASPPB Code of Conduct III(A)(4)statesmdashrdquoengage in ongoing consultation amp inform clients of the innovative nature amp known risks of the servicerdquo
Association of State and Provincial Boards of Psychology Code of Conduct available at
httpwwwokgovOSBEPdocumentsASPPB_Code_of_Conduct_20055B15Dpdf
26Northwest Center forPublic Health Practice
Issues
bull Informed Consent
bull Itrsquos required but how do I get it
27Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull Psychologists must obtain informed consent before providing services
bull For persons who are legally incapable of giving informed consent (eg children) psychologists must obtain informed assent
Exemplar of Informed Assent Form for child mental health study Claremont Grad School httpwwwcgueduincludeInformed_AssentFormdoc
28Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull For services for which generally recognized techniques have yet not been established psychologists inform the client of the developing nature amp potential risks of the procedure
29Northwest Center forPublic Health Practice
Analysis
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sectIII (D) (1)
bull Informed consent includes discussion of nature amp course of treatment fees involvement of third parties limits to confidentiality and the provision of sufficient opportunity for the client to ask questions
30Northwest Center forPublic Health Practice
NCPTSD Guidance
bull Introduce yourself with your name and title and describe your role Ask permission to talk to them and explain your objective of finding out whether there is anything you can do to make things easier or helping with ways to help themselves feel betterhellipWhen making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission When speaking with a child in distress when no adult is present it is important to find a parent or caregiver to let them know about your role and seek permission
National Center for PTSD Guidance for mental health providers in acute phase httpwwwncptsdvagovncmainindexjsp
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
25Northwest Center forPublic Health Practice
Recommended Guideline
ASPPB Code of Conduct III(A)(4)statesmdashrdquoengage in ongoing consultation amp inform clients of the innovative nature amp known risks of the servicerdquo
Association of State and Provincial Boards of Psychology Code of Conduct available at
httpwwwokgovOSBEPdocumentsASPPB_Code_of_Conduct_20055B15Dpdf
26Northwest Center forPublic Health Practice
Issues
bull Informed Consent
bull Itrsquos required but how do I get it
27Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull Psychologists must obtain informed consent before providing services
bull For persons who are legally incapable of giving informed consent (eg children) psychologists must obtain informed assent
Exemplar of Informed Assent Form for child mental health study Claremont Grad School httpwwwcgueduincludeInformed_AssentFormdoc
28Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull For services for which generally recognized techniques have yet not been established psychologists inform the client of the developing nature amp potential risks of the procedure
29Northwest Center forPublic Health Practice
Analysis
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sectIII (D) (1)
bull Informed consent includes discussion of nature amp course of treatment fees involvement of third parties limits to confidentiality and the provision of sufficient opportunity for the client to ask questions
30Northwest Center forPublic Health Practice
NCPTSD Guidance
bull Introduce yourself with your name and title and describe your role Ask permission to talk to them and explain your objective of finding out whether there is anything you can do to make things easier or helping with ways to help themselves feel betterhellipWhen making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission When speaking with a child in distress when no adult is present it is important to find a parent or caregiver to let them know about your role and seek permission
National Center for PTSD Guidance for mental health providers in acute phase httpwwwncptsdvagovncmainindexjsp
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
26Northwest Center forPublic Health Practice
Issues
bull Informed Consent
bull Itrsquos required but how do I get it
27Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull Psychologists must obtain informed consent before providing services
bull For persons who are legally incapable of giving informed consent (eg children) psychologists must obtain informed assent
Exemplar of Informed Assent Form for child mental health study Claremont Grad School httpwwwcgueduincludeInformed_AssentFormdoc
28Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull For services for which generally recognized techniques have yet not been established psychologists inform the client of the developing nature amp potential risks of the procedure
29Northwest Center forPublic Health Practice
Analysis
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sectIII (D) (1)
bull Informed consent includes discussion of nature amp course of treatment fees involvement of third parties limits to confidentiality and the provision of sufficient opportunity for the client to ask questions
30Northwest Center forPublic Health Practice
NCPTSD Guidance
bull Introduce yourself with your name and title and describe your role Ask permission to talk to them and explain your objective of finding out whether there is anything you can do to make things easier or helping with ways to help themselves feel betterhellipWhen making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission When speaking with a child in distress when no adult is present it is important to find a parent or caregiver to let them know about your role and seek permission
National Center for PTSD Guidance for mental health providers in acute phase httpwwwncptsdvagovncmainindexjsp
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
27Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull Psychologists must obtain informed consent before providing services
bull For persons who are legally incapable of giving informed consent (eg children) psychologists must obtain informed assent
Exemplar of Informed Assent Form for child mental health study Claremont Grad School httpwwwcgueduincludeInformed_AssentFormdoc
28Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull For services for which generally recognized techniques have yet not been established psychologists inform the client of the developing nature amp potential risks of the procedure
29Northwest Center forPublic Health Practice
Analysis
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sectIII (D) (1)
bull Informed consent includes discussion of nature amp course of treatment fees involvement of third parties limits to confidentiality and the provision of sufficient opportunity for the client to ask questions
30Northwest Center forPublic Health Practice
NCPTSD Guidance
bull Introduce yourself with your name and title and describe your role Ask permission to talk to them and explain your objective of finding out whether there is anything you can do to make things easier or helping with ways to help themselves feel betterhellipWhen making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission When speaking with a child in distress when no adult is present it is important to find a parent or caregiver to let them know about your role and seek permission
National Center for PTSD Guidance for mental health providers in acute phase httpwwwncptsdvagovncmainindexjsp
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
28Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect310 1001 amp ASPPB Code of Conduct sect III (D) (1)
bull For services for which generally recognized techniques have yet not been established psychologists inform the client of the developing nature amp potential risks of the procedure
29Northwest Center forPublic Health Practice
Analysis
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sectIII (D) (1)
bull Informed consent includes discussion of nature amp course of treatment fees involvement of third parties limits to confidentiality and the provision of sufficient opportunity for the client to ask questions
30Northwest Center forPublic Health Practice
NCPTSD Guidance
bull Introduce yourself with your name and title and describe your role Ask permission to talk to them and explain your objective of finding out whether there is anything you can do to make things easier or helping with ways to help themselves feel betterhellipWhen making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission When speaking with a child in distress when no adult is present it is important to find a parent or caregiver to let them know about your role and seek permission
National Center for PTSD Guidance for mental health providers in acute phase httpwwwncptsdvagovncmainindexjsp
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
29Northwest Center forPublic Health Practice
Analysis
bull APA Ethical Rule sect 310 1001 amp ASPPB Code of Conduct sectIII (D) (1)
bull Informed consent includes discussion of nature amp course of treatment fees involvement of third parties limits to confidentiality and the provision of sufficient opportunity for the client to ask questions
30Northwest Center forPublic Health Practice
NCPTSD Guidance
bull Introduce yourself with your name and title and describe your role Ask permission to talk to them and explain your objective of finding out whether there is anything you can do to make things easier or helping with ways to help themselves feel betterhellipWhen making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission When speaking with a child in distress when no adult is present it is important to find a parent or caregiver to let them know about your role and seek permission
National Center for PTSD Guidance for mental health providers in acute phase httpwwwncptsdvagovncmainindexjsp
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
30Northwest Center forPublic Health Practice
NCPTSD Guidance
bull Introduce yourself with your name and title and describe your role Ask permission to talk to them and explain your objective of finding out whether there is anything you can do to make things easier or helping with ways to help themselves feel betterhellipWhen making contact with children or adolescents it is good practice to make a connection with a parent or accompanying adult to explain your role and seek permission When speaking with a child in distress when no adult is present it is important to find a parent or caregiver to let them know about your role and seek permission
National Center for PTSD Guidance for mental health providers in acute phase httpwwwncptsdvagovncmainindexjsp
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
31Northwest Center forPublic Health Practice
Conclusion
bull Informed Consent is required for disaster mental health providers and researchers
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
32Northwest Center forPublic Health Practice
Issues
bull Confidentialitybull Needs to be discussed but can you
promise it
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
33Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 401 402 amp ASPPB Code of Conduct sect II (B) III (F)
bull Psychologists must provide confidentiality to clients
bull Psychologists must document the clientrsquos consent or assent
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
34Northwest Center forPublic Health Practice
Analysis
bull Psychologists discuss with clients the relevant limits of confidentiality the foreseeable uses of the confidential information
bull Unless not feasible psychologists discuss the issue of confidentiality at the outset of the relationship
bull Confidential information may only be disclosed with written permission except upon court order or to conform with law
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
35Northwest Center forPublic Health Practice
Conclusion
bull Confidentiality is required within certain parameters but there are limits to confidentiality eg imminent harm to self or othersndash you MUST notify authorities Also you MUST report child abuse and elder abuse to authorities You may also communicate with other providers to ensure continuity of care
bullRefer to HIPAA Disclosures in an emergency document httpwwwhhsgovocrhipaadecisiontool
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
36Northwest Center forPublic Health Practice
Issues
bull Record Keepingbull It is required and it is probably not
being done correctly (or at all in some cases)
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
37Northwest Center forPublic Health Practice
Rule
bull APA Ethical Rule sect 601 602 amp ASPPB Code of Conduct sect III (A)(7)
bull Psychologists must keep records amp the records must be kept confidential
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
38Northwest Center forPublic Health Practice
Analysis
bull Records must include clientrsquos name the presenting problem(s) or purpose or diagnosis fee arrangement the date and substance of each service
bull Records must include any evaluative result notation amp results of consults a copy of reports and any releases executed by the client
bull Records must be kept for not less than five years
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
39Northwest Center forPublic Health Practice
CASE EXAMPLE
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
40Northwest Center forPublic Health Practice
You are working at a Mass Dispensing site four days after anthrax has been released at three local area malls A
woman with two elementary aged children are in line to obtain medication and one child about 11 years old is crying
hysterically You a Team Leader instruct another mental health volunteer to intervene
What are the legal and ethical ssues What should you do
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
41Northwest Center forPublic Health Practice
bull Record Keeping
bull Licensure
bull Vicarious liability- supervisors are potentially responsible for negligent actions of subordinates
Issues
bull Standard of Practice
bull Informed Consent
bull Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
42Northwest Center forPublic Health Practice
You are a member of an organization (the organization could be religious based professional based or governmental based) that provides DMHWs who work with children and
families during the acute phase of a disaster It has been your job to develop a database of volunteers arrange and deploy volunteers when a disaster occurs and act as a team leader
at the disaster site shelter etc when the volunteers are deployed
What are the issues What should you do
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
43Northwest Center forPublic Health Practice
bull Post-deployment screening
Issues
bull Training amp licensure
bull Supervision
bull Pre-deployment screening
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
44Northwest Center forPublic Health Practice
What Special Laws Apply In Disasters
bull Emergency Management Compact (most states)- EMAC is an agreement among states to provide assistance across state in a disaster
See httpwwwemacweborg1530
bull ldquoFederalizationrdquo amp the Federal Volunteer Protection Act (42 USC sect 14501 etseq) AKA the Federal Volunteer Protection Act of 1997
See httpwwwdisastermhnebraskaedufilesAppendix-H-Federal_Volunteer_Protection_Act_pdf
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
45Northwest Center forPublic Health Practice
Stipulations of Volunteer Protection Act- Civil liability protection is offered to non-profit or government volunteers
if
bull The volunteer was acting within their scope of responsibilitybull The volunteer was properly license certified or authorized to
engage in their disaster related activity or practice bull The harm was not caused by willful or criminal misconduct gross
negligence reckless misconduct or a ldquoconscious flagrant indifferencerdquo to the rights or safety of the individual harmed by the volunteer and
bull This statute does not refer to ldquospontaneous volunteersrdquo who may or may not be licensed and who are not serving in a formal capacity for a NGO such as the Red Cross or a government disaster volunteer agency such as the Medical Reserve Corps or Community Emergency Response Teams
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
46Northwest Center forPublic Health Practice
Analysis amp Conclusion
bull Disaster related laws provide limited liability protection amp waiver of state licensing requirements under certain circumstances
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
47Northwest Center forPublic Health Practice
What Special Laws Apply In Pandemics amp Bioterrorist Events
bull Model State Emergency Health Powers Act (MSEPHA)
bull Washington Oregon and Alaska have considered or passed some components of the MSEPHA
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
48Northwest Center forPublic Health Practice
Public Health Law in the Age of Bioterrorism
bull For an excellent overview of Public Health law that may apply in a pandemic or bioterrorist I recommend the on-line tutorial e-course offered by the Northwest Center of Public Health Practice
bull This course may be accessed httpwwwnwcphporgtrainingcourses-exercisescoursesintroduction-to-public-health-law
Course faculty Patricia Kuzler MD JD Associate Dean University of Washington School of Law
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
49Northwest Center forPublic Health Practice
Special Issues In Disaster Research
bull Decisional capacity of potential participants
bull Vulnerability of subjects
bull Risks and benefits of research participation
bull Informed consent
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
50Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull When needed formally assess decisional competence
bull Train researchers to recognize emotional problems in subjects amp have referral sources available
bull Carefully assess study riskbenefits
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
51Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Involve community members in research planning
bull Reduce likelihood that research is perceived as treatment
bull Setting for informed consent should be safe
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
52Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Provisions for confidentiality should be explicit
bull Should be explicit plans for training and mental health support of researchers and staff
bull Inform subjects of study results
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
53Northwest Center forPublic Health Practice
Recommended Disaster Research Guidelines
bull Coordination among researchers and IRBs--bull Proactive involvement of IRBrsquos in research
planning to remove barriers to timely data collection
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
54Northwest Center forPublic Health Practice
Disaster ResearchThoughts Issues amp Recommendations
from the
University of Washington
HSDIRB
UW Human Subjects DivisionRichard Brzustowicz Administrator RovingZan Manning Administrator Minimal RiskSharon Smith Elsayed Asst Dir for Education amp Communication July 12 2007
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
55Northwest Center forPublic Health Practice
Acknowledgement
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Disaster mental health research poses unique issues and
challenges to researchers and to the HSDIRB
bull It is important that the unique issues and recommended
guidelines presented earlier be understood addressed and
acted upon by all involved disciplines
bull HSD is currently developing policies and procedures to
address special situations and needs like disaster research
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
56Northwest Center forPublic Health Practice
Thoughts
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The process of working with the HSDIRB can be flexible and is likely able to be less formal than might be expected
bull Proactive involvement of the HSDIRB is encouraged and highly desirable
bull It is the preservation of the foundational principles of ethical research that is paramount to the HSDIRB
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
57Northwest Center forPublic Health Practice
Foundational Principles Source Belmont Report
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Respect for personsIndividual autonomy and the protection of individuals with diminished autonomy
bull BeneficenceMaximize benefits and minimize harms
bull JusticeEquitable distribution of research costs and benefits
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
58Northwest Center forPublic Health Practice
Issues (not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull The Belmont principles may not carry equal importance or may even be in conflict with each other depending on the research intent and design
bull Consent process ndash how to assure that it makes sense within the context of what has occurred and who is involved potentially and in reality
bull Clarity regarding the distinction between the provision of service and the conduct of research
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
59Northwest Center forPublic Health Practice
Recommendations (again not a comprehensive list)
Disaster Research Thoughts Issues amp Recommendations from the HSDIRB
bull Proactive preparation and submission of an IRB application for approval in advance of a potential disaster with annual renewal and modifications ndash as needed due to changes over time or in actual event circumstances
bull Keep specific aspects of the application and research protocol flexible in order to minimize the need for change
bull Work with institutions and individuals to lay the groundwork
bull Integrate research into normal routines to the extent possible
bull Try-it-out in ldquocontrolledrdquo approximations (marathons drills etc)
bull Consider applying for a Federal Certificate of Confidentiality
