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Institutional Review Board (IRB) for Human Subject Protections:
Working with the IRB
Erin McClure, PhDErin McClure, PhDDepartment of Psychiatry and Behavioral SciencesDepartment of Psychiatry and Behavioral Sciences
Previous TrainingPrevious Training
Previous TrainingPrevious Training
The Belmont Report
3 Basic Principles for Protection of Human Subjects:
– Respectvoluntary informed consentprivacyprotections for vulnerable populations
– Beneficence
– Justice
Beneficence
Persons treated in an ethical manner
Protecting them from harm
Helping to secure their well being
Justice
• Who ought to receive the benefits of research and bear the burden of research?
• Equals ought to be treated equally
• Fairness in distribution
• What is deserved
Informed Consent
• Essential to ethical conduct of clinical investigation• Potential subject chooses whether or not
they will participate• Obtained after full information is given and understood• Explanation of study objective, potential
benefits, risks, inconveniences, subject’s rights and responsibilities
Valid Informed Consent
3 Key Components
1. Informed
2. Understood
3. Voluntary
Ensuring Adequate Informed Consent
Given the imperative to protect the rights of participants, how can we be sure that our informed consent process is sufficient?
Ideas:– Reading aloud– Ask the participant questions– Quiz– Signatures and dates
Therapeutic MisconceptionTherapeutic Misconception
Most studies are not designed to directly Most studies are not designed to directly benefit study participantsbenefit study participants
Important to help participant understand that Important to help participant understand that research is not the same as clinical research is not the same as clinical treatmenttreatment
If participant does not understand the If participant does not understand the difference, consent is not validdifference, consent is not valid
IRB Purpose
To protect the rights and welfare of human research subjects
Authority to approve, require modification and disapprove any research involving human subjects
Protecting Participants from Harm
Does not mean study must be minimal risk Have appropriate selection criteria to exclude
individuals at greater risk of harm Have study procedures to evaluate
participants’ safety Have DSMB to monitor study progress Potentially stop study early / revise protocol if
there are significant risks or benefits identified
Institutional Review Board
Responsible for verifying
1. Safety
2. Integrity
3. Human rights
4. Public reassurance
5. Scientific content
What information is reviewed? Protocol Informed Consent Document(s) Informed Consent process HIPAA Authorizations/Waivers Personnel-including who will obtain consent Recruitment process/plan Advertisements Investigator’s brochure Compensation FDA information (if applicable) Medical device information Adverse events/DSMB
Recruitment Process How you recruit for your study must be
approved by the IRB:– Advertisements– Word of mouth– Medical Record Review– Asking medical providers to provide letter to
possible participants– Directly approaching potential participant– “Cold calling” is not allowed
Investigator Obligations• Conducts a clinical investigation
• Responsible for
All procedures conducted
All data collected
• May delegate work in conducting study but they retain responsibility
•Protecting Participants•Implementing Study•Reporting Accurately
The Mountain of Responsibility
OHRP Suspensions
During the last 8-9 years, OHRP has suspended all human research at the following institutions:– University of Illinois, Chicago Campus– University of Colorado– Duke University– Johns Hopkins– University of Pennsylvania– And others
Submitting an IRB Application Pay attention to deadlines!
– http://academicdepartments.musc.edu/research/ori/irb/deadlines.html
Clearly articulate what you are doing for research purposes
Do a mental walk through of your study– Where will it be done? By whom?– What will participants do? In what order?– What data do you need? How/where will data be
stored?
Lessons learnedLessons learned– They are doing their job! i.e., protecting They are doing their job! i.e., protecting
human subjectshuman subjects
– Support as much as you can with evidenceSupport as much as you can with evidence
– Pick your battlesPick your battles
– Communicate frequently with IRB staffCommunicate frequently with IRB staff
– ““Better to ask for forgiveness than Better to ask for forgiveness than permission.” Well, sometimes….permission.” Well, sometimes….
Working with the IRB
Informed consent while Informed consent while
under the influenceunder the influence
Examples and Experiences
Deception or withholding Deception or withholding informationinformation
Examples and Experiences
Pregnancy and urine drug screensPregnancy and urine drug screens
“If you are or become pregnant and test positive for illegal drugs, it is a law that the South Carolina Department of Social Services (DSS) must be notified. You and your
family will be evaluated by the agency. You could be ordered to mandatory drug treatment, lose custody of your children, or possibly be jailed.”
Examples and Experiences
Conducting research with Conducting research with adolescentsadolescents
Examples and Experiences
Conducting multi-site studiesConducting multi-site studies
Examples and Experiences
Use of “experimental” devicesUse of “experimental” devices
Examples and Experiences
Regulatory Support
Call the SUCCESS CENTERCall the SUCCESS CENTER
At 792-8300At 792-8300
Useful Regulatory/Policy Material
MUSC IRBMUSC IRB http://academicdepartments.musc.edu/research/http://academicdepartments.musc.edu/research/
ori/irb/ori/irb/ http://academicdepartments.musc.edu/research/http://academicdepartments.musc.edu/research/
ori/irb/deadlines.htmlori/irb/deadlines.html
Office for Human Research ProtectionsOffice for Human Research Protections http://www.hhs.gov/ohrp/http://www.hhs.gov/ohrp/
Food & Drug AdministrationFood & Drug Administration http://www.fda.gov/oc/ohrt/irbs/default.htmhttp://www.fda.gov/oc/ohrt/irbs/default.htm
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