View
57
Download
1
Category
Preview:
DESCRIPTION
Purdue Extension Human Subjects Training. Based on CITI Course in the Protection of Human Subjects Research Fall 2004. History and Ethical Principles Defining Research with Human Subjects Regulatory Overview Assessing Risk Informed Consent. Privacy and Confidentiality - PowerPoint PPT Presentation
Citation preview
Purdue ExtensionPurdue ExtensionHuman SubjectsHuman Subjects
TrainingTraining
Based on CITI Based on CITI
Course in the Protection of Course in the Protection of Human Subjects ResearchHuman Subjects Research
Fall 2004Fall 2004
Topics To Be CoveredTopics To Be Covered
History and Ethical History and Ethical PrinciplesPrinciples
Defining Research Defining Research with Human with Human SubjectsSubjects
Regulatory Overview Regulatory Overview Assessing RiskAssessing Risk Informed ConsentInformed Consent
Privacy and Privacy and ConfidentialityConfidentiality
Research with Research with PrisonersPrisoners
Research with Research with ChildrenChildren
Research in Public Research in Public SchoolsSchools
Internet ResearchInternet Research
History and Ethical PrinciplesHistory and Ethical Principles
Provides a Structure for Analysis and Provides a Structure for Analysis and Decision makingDecision making
Supports – Reminds to Protect Supports – Reminds to Protect Human subjectsHuman subjects
Aids in Assessing Risks and BenefitsAids in Assessing Risks and Benefits
Historical InfluencesHistorical Influences
Nuremberg CodeNuremberg Code Resulted from Nazi Doctors AtrocitiesResulted from Nazi Doctors Atrocities The Code didn’t Impact U.S. ScientistsThe Code didn’t Impact U.S. Scientists
Declaration of HelsinkiDeclaration of Helsinki Broadened Nuremberg CodeBroadened Nuremberg Code
Historical Case StudiesHistorical Case Studies
Obedience to Authority StudyObedience to Authority Study Involved Deception of SubjectsInvolved Deception of Subjects
Caused Some Emotional ProblemsCaused Some Emotional Problems
Public Health Service Syphilis StudyPublic Health Service Syphilis Study 1932-19721932-1972 Withheld Available TreatmentWithheld Available Treatment Led to Establishment of National Led to Establishment of National
Research ActResearch Act Current Protections for Human SubjectsCurrent Protections for Human Subjects
Ethical ProblemsEthical Problems
Lack of Informed ConsentLack of Informed Consent CoercionCoercion Use/Exploitation of Vulnerable Use/Exploitation of Vulnerable
PopulationsPopulations Withholding information including Withholding information including
about risksabout risks Failure to Assess Risks vs. BenefitsFailure to Assess Risks vs. Benefits DeceptionDeception Violation of RightsViolation of Rights
The Belmont ReportThe Belmont Report
1974 National Commission formed to 1974 National Commission formed to study Human subjects concernsstudy Human subjects concerns
1979 Belmont Report1979 Belmont Report Respect For PersonsRespect For Persons BeneficenceBeneficence JusticeJustice
No One Principle “Trumps” AnotherNo One Principle “Trumps” Another All must be weighed equallyAll must be weighed equally
From Principles to PracticeFrom Principles to Practice RespectRespect
BeneficenceBeneficence
JusticeJustice
Informed ConsentInformed Consent VoluntarinessVoluntariness
Risks/BenefitsRisks/Benefits Privacy/Privacy/
ConfidentialityConfidentiality = Burdens = Burdens
=Benefits=Benefits DiversityDiversity
Regulatory OverviewRegulatory Overview
Common Rule (45 CFR 46)Common Rule (45 CFR 46) Department of Health and Human Department of Health and Human
ServicesServices All Institutions that Receive DHHS FundsAll Institutions that Receive DHHS Funds Subparts to Common RuleSubparts to Common Rule Special Protections forSpecial Protections for
Prisoners- Subpart CPrisoners- Subpart C Children – Subpart DChildren – Subpart D Pregnant Women (when their pregnancy Pregnant Women (when their pregnancy
affects their ability to participate) fetuses, affects their ability to participate) fetuses, neonates -Subpart Bneonates -Subpart B
The Common RuleThe Common Rule
Dictates What an IRB Should doDictates What an IRB Should do The basic criteria for IRB review of The basic criteria for IRB review of
protocolsprotocols Description of the types of reviewDescription of the types of review Composition of the IRBComposition of the IRB
Primary PurposePrimary Purpose Protect the rights and welfare of Protect the rights and welfare of
research subjectsresearch subjects
Institutional Review Board (IRB)Institutional Review Board (IRB)
Evaluates ResearchEvaluates Research According to Belmont Report PrinciplesAccording to Belmont Report Principles Respect for PersonsRespect for Persons BeneficenceBeneficence JusticeJustice
Federal Regulations derived from itFederal Regulations derived from it Common RuleCommon Rule
IRB Committee Decision is FinalIRB Committee Decision is Final No one can override a decision of the No one can override a decision of the
IRBIRB
Defining Research Defining Research
A Systematic InvestigationA Systematic Investigation Research Development, Testing, EvaluationResearch Development, Testing, Evaluation
Contributes to Generalizable KnowledgeContributes to Generalizable Knowledge Will it be Disseminated?Will it be Disseminated?
Will it be Read by others outside of Purdue Will it be Read by others outside of Purdue Extension?Extension?
Poster SessionsPoster Sessions Journal ArticlesJournal Articles Impact StatementsImpact Statements
Human SubjectsHuman Subjects
DefinitionDefinition ““A living Individual about whom an A living Individual about whom an
investigator conducting research obtains:investigator conducting research obtains: Data through intervention or interaction with Data through intervention or interaction with
the individualthe individual Identifiable private information”Identifiable private information”
Private InformationPrivate Information Reasonable Expectation of PrivacyReasonable Expectation of Privacy Provided for Specific Purpose – not to be Provided for Specific Purpose – not to be
made publicmade public
BenefitBenefit
A positive value to the individual of A positive value to the individual of participating in a studyparticipating in a study Direct BenefitsDirect Benefits Indirect BenefitsIndirect Benefits Benefits to Science and societyBenefits to Science and society
RiskRisk Harms that may occur to individualHarms that may occur to individual
Probability and MagnitudeProbability and Magnitude May be:May be:
PhysicalPhysical SocialSocial EconomicEconomic LegalLegal PsychologicalPsychological
Weigh Risks against Potential BenefitsWeigh Risks against Potential Benefits Not all Risks and Benefits may be Not all Risks and Benefits may be
knownknown
Assessing RiskAssessing Risk Falls into 3 General CategoriesFalls into 3 General Categories
Invasion of PrivacyInvasion of Privacy Information accessed without knowledge or Information accessed without knowledge or
consentconsent Breach of ConfidentialityBreach of Confidentiality
May be unintentionalMay be unintentional Information disclosed outside to research Information disclosed outside to research
settingsetting Study ProceduresStudy Procedures
Just participating can cause stress or issues of Just participating can cause stress or issues of privacyprivacy
Can be culturally determinedCan be culturally determined
Managing RisksManaging Risks Collect Data without IdentifiersCollect Data without Identifiers Remove all Direct IdentifiersRemove all Direct Identifiers Code DataCode Data Keep code lists and data separatelyKeep code lists and data separately Aggregate Data so as not to identifyAggregate Data so as not to identify Secure Technology/computersSecure Technology/computers Minimize risks of exposure from Minimize risks of exposure from
ParticipationParticipation Sensitive to Psychological RisksSensitive to Psychological Risks
Privacy in ResearchPrivacy in Research Privacy/of participantPrivacy/of participant
About the personAbout the person Identifying and Recruiting subjectsIdentifying and Recruiting subjects Covert observationCovert observation Privacy of Third partiesPrivacy of Third parties Sensitive QuestionsSensitive Questions Limits to ConfidentialityLimits to Confidentiality
Child/Elder Abuse ReportingChild/Elder Abuse Reporting Focus GroupsFocus Groups
Research with PrisonersResearch with Prisoners
Definition:Definition: Some one in the legal systemSome one in the legal system
Consent Issues with PrisonerConsent Issues with Prisoner Free ChoiceFree Choice Undue InducementsUndue Inducements Breach of ConfidentialityBreach of Confidentiality Sensitive Questions when there is no Sensitive Questions when there is no
supportsupport IRB must include an Prisoner Advocate IRB must include an Prisoner Advocate
when reviewingwhen reviewing
Research with ChildrenResearch with Children
Definition:Definition: Persons who have not yet attained the Persons who have not yet attained the
legal age of consent. In IN it is 18legal age of consent. In IN it is 18 In Commonly Accepted Educational In Commonly Accepted Educational
SettingsSettings Research about educational TestsResearch about educational Tests
““Is your survey to find out what they Is your survey to find out what they learned, or what behavior changed?”learned, or what behavior changed?”
Not ExemptNot Exempt
Studies with Children cannot be Studies with Children cannot be Exempt when:Exempt when:
Interviews and or surveys outside of Interviews and or surveys outside of an educational experiencean educational experience
Observations when the researcher Observations when the researcher participates in the activities observedparticipates in the activities observed
Will require an Expedited or Full Will require an Expedited or Full ReviewReview
Issues with ChildrenIssues with Children
Potential Coercion Potential Coercion Peer PressurePeer Pressure Child Abuse/Neglect ReportingChild Abuse/Neglect Reporting Age AppropriatenessAge Appropriateness CompensationCompensation
Written Informed ConsentWritten Informed Consent
Required for Expedited and Full Required for Expedited and Full ReviewsReviews
Include:Include: Purpose of the ResearchPurpose of the Research Procedures to be FollowedProcedures to be Followed Risks or DiscomfortsRisks or Discomforts BenefitsBenefits How records will be MaintainedHow records will be Maintained Compensation if anyCompensation if any Contact InformationContact Information Voluntary Statement/Ability to WithdrawVoluntary Statement/Ability to Withdraw
Issues of Informed ConsentIssues of Informed Consent RecruitmentRecruitment Language/Cultural AppropriatenessLanguage/Cultural Appropriateness
Reading LevelsReading Levels Rights and Welfare SubjectsRights and Welfare Subjects Potential CoercionPotential Coercion Waivers of parental consent may be Waivers of parental consent may be
granted:granted: Parent’s knowledge of situation my Parent’s knowledge of situation my
cause harmcause harm Child is emancipatedChild is emancipated
Research in Public SchoolsResearch in Public Schools Regulations affecting schoolsRegulations affecting schools
Common RuleCommon Rule Common Rule –Subpart D for ChildrenCommon Rule –Subpart D for Children Family Education Rights and Privacy Act Family Education Rights and Privacy Act
FERPAFERPA Educational RecordsEducational Records
Protection of Pupil Rights Amendment Protection of Pupil Rights Amendment PPRA-PPRA-
Written Notification to Parents for SurveysWritten Notification to Parents for Surveys No Child Left Behind ActNo Child Left Behind Act
Surveys containing sensitive TopicsSurveys containing sensitive Topics
Internet ResearchInternet Research
Observing On-Line CommunicationsObserving On-Line Communications Are they Public or Private?Are they Public or Private?
Technical IssuesTechnical Issues Email is not secureEmail is not secure IP Addresses can be used to Identify IP Addresses can be used to Identify
SubjectsSubjects Ensure Servers are secureEnsure Servers are secure Encrypt Data Encrypt Data Storage of data must be protectedStorage of data must be protected
Issues with Internet ResearchIssues with Internet Research
Ensuring ComprehensionEnsuring Comprehension Underage ParticipantsUnderage Participants WithdrawalWithdrawal Documenting ConsentDocumenting Consent PrivacyPrivacy IdentifiersIdentifiers Breach of ConfidentialityBreach of Confidentiality Assessing RisksAssessing Risks
WorkersWorkers Some Argue that Workers are a Some Argue that Workers are a
Vulnerable populationVulnerable population Issues of workers as subjectsIssues of workers as subjects
Effects of individual entitlementsEffects of individual entitlements Impairment of Family RelationshipsImpairment of Family Relationships Possible threats to job retentionPossible threats to job retention Peer PressurePeer Pressure Constraints to Job AdvancementConstraints to Job Advancement Findings may affect individuals, Findings may affect individuals,
corporations, unions, governmentcorporations, unions, government
Exempt ResearchExempt Research
Educational SettingsEducational Settings Surveys, Interviews, and Surveys, Interviews, and Observation Observation
of Adults of Adults Research on Public OfficialsResearch on Public Officials Existing DataExisting Data Federal Govt. Public BenefitFederal Govt. Public Benefit Consumer Evaluation/Taste TestingConsumer Evaluation/Taste Testing Implied Consent- VoluntaryImplied Consent- Voluntary
Expedited ReviewExpedited Review
No More than Minimal RiskNo More than Minimal Risk Falls into one of the 9 eligible categoriesFalls into one of the 9 eligible categories
Medical drugs and devices approved by FDAMedical drugs and devices approved by FDA Collection of biological specimensCollection of biological specimens Collection of data from audio, video, or Collection of data from audio, video, or
image recordingimage recording Non-exempt research using surveys, Non-exempt research using surveys,
interviews, observationsinterviews, observations OthersOthers
Full ReviewFull Review
Greater than Minimal RiskGreater than Minimal Risk Use of a Vulnerable PopulationUse of a Vulnerable Population
Must be present at IRB Committee Must be present at IRB Committee meetingmeeting
Continuing Reviews will go back to Continuing Reviews will go back to the full committee for approvalthe full committee for approval
Continuing Reviews/RevisionsContinuing Reviews/Revisions
Approval is for 364 DaysApproval is for 364 Days Continuing Review for Exempt ApprovalContinuing Review for Exempt Approval Approximately 10 months after approvalApproximately 10 months after approval Email continuing review formEmail continuing review form Complete and send backComplete and send back Same process for an Expedited or Full ReviewSame process for an Expedited or Full Review Revisions- for allRevisions- for all Complete the Revision form for all revisions,Complete the Revision form for all revisions, Send to IRB who approvedSend to IRB who approved
CITI Site for QuizCITI Site for Quiz
https://www.citiprogram.org/default.asp
Log –inLog –in Choose “Purdue Extension Educators” Choose “Purdue Extension Educators” Click on Basic CourseClick on Basic Course Complete IntroductionComplete Introduction Complete Extension Institutional PageComplete Extension Institutional Page Scroll down to complete the quizScroll down to complete the quiz
If you pass, download a completion reportIf you pass, download a completion report If not, try again, using the CITI ModulesIf not, try again, using the CITI Modules
Extension Exempt ProcessExtension Exempt Process
Complete X-HS-03-1Complete X-HS-03-1 Attach Instrument and PublicityAttach Instrument and Publicity Send Electronically to DDSend Electronically to DD He/she will Forward to IRB coordinatorHe/she will Forward to IRB coordinator Reviewed by Extension Human Subjects Reviewed by Extension Human Subjects
Comm.Comm. Sent to Three ReviewersSent to Three Reviewers
When all agree, approval is Emailed, withWhen all agree, approval is Emailed, with Official notification sent from Director’s Official notification sent from Director’s
officeoffice
Process for Expedited and Full Process for Expedited and Full ReviewsReviews
Complete Application on IRB websiteComplete Application on IRB website Write a Narrative Describing ResearchWrite a Narrative Describing Research Develop a Consent FormDevelop a Consent Form Send to Director’s office to sign as P.I.Send to Director’s office to sign as P.I. Will be sent to Purdue IRB for reviewWill be sent to Purdue IRB for review IRB will review the research component of IRB will review the research component of
the projectthe project IRB will review and asks for clarificationIRB will review and asks for clarification Plan ahead for QuestionsPlan ahead for Questions
Questions????Questions????
If you have questions, please contact Janet Bechman, If you have questions, please contact Janet Bechman, Extension Plan of Work & Accountability Coordinator, Extension Plan of Work & Accountability Coordinator,
jcb@purdue.edujcb@purdue.edu
Prepared by Prepared by Catherine E. Burwell, Ph.D.Catherine E. Burwell, Ph.D.
Extension IRB and Reporting CoordinatorExtension IRB and Reporting Coordinator ceb@purdue.educeb@purdue.edu
Recommended