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U-M NRE 701 - Human Subject Protection

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Human Subject ProtectionWhat is Research?Who is a Human Subject?What is an Intervention?Interaction?Private Information? (part 1)Private Information (part 2)Private Information (part 3)Historical EventsNurembergInternational Codes of Research Ethics“Tuskegee Study of Untreated Syphilis in the Negro Male”US ResponseBelmont ReportRespect for PersonsBeneficenceDistributive JusticeInformed ConsentElements of Informed ConsentElements…Role of the IRBIRB Structure/Types of ReviewIRB Review ProcessStaying in ComplianceCommon PitfallsOversightWhat do these have in common?What do IRBs Worry About?WorriesAnd More WorriesThe Best SolutionsHuman Subject ProtectionJudith BirkIRB Health / Behavioral SciencesWhat is Research?A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge 45CFR46.102(d)Who is a Human Subject?A living individual about whom an investigator (whether professional or a student) conducting research obtains data through intervention or interaction with the individual, or private information 45CFR46.102(f)What is an Intervention?Physical procedures (like a blood draw) and manipulations of the subject or the subject’s environment that are performed for research purposesInteraction?Communication or interpersonal contact between the investigator and subjectPrivate Information?(part 1)-Information about a behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking placePrivate Information(part 2)…and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made publicPrivate Information(part 3)Private information must be individually identifiable in order for obtaining the information to constitute research involving human subjectsHistorical Events•Nuremberg Doctors Trial of 1946–23 defendants (20 physicians) charged with murder in the name of medical science–15 found guilty –7 sentenced to deathNuremberg•Vacuum chamber: 40% mortality•Cold water immersion: 30%•Traumatic amputations: 50%•Chemical warfare agent testing: 25%International Codes of Research Ethics•Nuremberg Code 1947•Declaration of Helsinki 1964“Tuskegee Study of Untreated Syphilis in the Negro Male”•Predecessor of CDC designed the study to demonstrate the need to establish syphilis treatment programs in 1932•Study would investigate the effects of the untreated disease on a short term basis•Penicillin was accepted as treatment in 1943•Lack of treatment revealed by the Associated Press in 1972US Response•National Research Act 1974–National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research •The Belmont Report•US Code of Federal Regulations–Title 21 Food and Drugs–Title 45 Part 46 (Common Rule)Belmont Report•Respect for persons•Beneficence•Distributive JusticeRespect for Persons •Individuals should be treated autonomously•Their informed consent should be freely givenBeneficence•Do no harm•Maximize possible benefits and minimize the risksDistributive Justice•Equitable selection of research subjectsInformed Consent•A process, not just a document–Informed–Understood–VoluntaryElements of Informed Consent•It is research•What are the reasonably foreseeable risks•Are there benefits•Alternative treatments or procedures •Record confidentiality•If more than minimal risk will there be treatment or compensation of/for any harmsElements… •Who has information and can help•Participation is voluntary and it is okay to stopRole of the IRB•Review and approve research involving human subjects•Conduct continuing review/oversight•Informed consent•Risk/benefit•Vulnerable subjects•Other special considerationsIRB Structure/Types of Review•Convened (Full) Board•Expedited•ExemptIRB Review Process•Initiate a complete, thoughtful application–Informed consent, supporting documents, permissions•Administrative review•Convened board or Chair review•Administrative follow-up•Repeat bullets 3 and 4 as necessary•Final approval•Notification providedStaying in Compliance•Don’t initiate research before obtaining IRB approval•Renew ongoing proposals each year in a timely fashion (not fashionably late…)•Stay within the approved scope of the project•Submit modifications to the IRB before initiating the change to the research •Report Adverse EventsCommon Pitfalls•Letting an active project lapse in approval•Failing to get approval in the first place (there are no retroactive approvals)•Exceeding the scope of the approval•Using materials which are not IRB approvedOversight•Federal–OHRP (Office of Human Research Protections) –FDA•Local–IRB (Institutional Review Boards)What do these have in common?•Duke University•Rush-Presbyterian Chicago•Johns Hopkins•University of Colorado•Virginia Commonwealth•University of PennsylvaniaWhat do IRBs Worry About?Informed consent Well, I think I understand this -- you only want me to umhh, well, what was that thing you said…WorriesCoercion Gee, I’m not sure about this, but I could really use the $1300 they’re offering me.And More WorriesRisk/Benefit Let’s see, you’re saying that I only need to wear a blindfold and walk across this 5 lane highway - right? Well, you ARE the scientist, you must know what you are doing.The Best Solutions•Just ask–Your faculty mentor–The


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U-M NRE 701 - Human Subject Protection

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