IRB Overview - Research Protections for Human Participants:...

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Research Protections for Human Participants: IRBs and the Researcher Plan for the presentation: Evolution of Research Protections Code of Federal Regulations And who it applies to OHRP and the administration of “the Regs” IRB02 Structure and Practice at UF Submitting your protocol to the IRB02 Some issues and controversies
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Ethical Dilemmas The ethics of research on humans “The difficult ethical questions are not raised by bad people doing bad things for no reason, but by good people doing bad things for good reasons” Individual autonomy versus the Greater Good Emmanuel Kant versus David Hume? Evidence-based ethics? the Journal of Empirical Research on Human Research Ethics
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Evolution of Research Protections WW2 Nazi medical “experiments” and the Nuremburg Code (1948) Voluntary and informed consent Benefits commensurate to the risks Right to withdraw without penalty The Declaration of Helsinki (WMA, 1964) Adopts key elements of the Nuremburg Code Participant’s interests trump those of society In clinical research, all should get best known treatment
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Evolution of Research protections in US Infamous cases of nonprotection in US Abuses in biomedical research Medical studies of conscientious objectors in WW2 Tuskegee Syphilis Study (1932-1972) [“Miss Evers’ Boys”] Willowbrook Hepatitis Study (1950’s) San Antonio Contraception Study (1972) Beecher’s NEJM paper (1966) reviews 22 such cases Abuses in the behavioral and social sciences Wichita Jury Study (1955) Milgram’s Obedience Study (1963) Tea Room Trade Study (1970) Zimbardo’s Prison Study (1972)
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Establishing Research Protections in the US Congressional hearings on research ethics (1973) National Research Act (1974) Establishes first federal regulations and IRBs Creates a National Commission for Protection of Human Subjects of Biomedical and Behavioral Research National Commission issues reports 1975-1978 Vulnerable populations (pregnant women, prisoners) Regulations modified and expanded in response issues the Belmont Report , 1978
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Evolution of Research Protections The Belmont Report (1978) Respect for persons (be nice!) informed consent to participate and to withdraw consent Privacy of individual, confidentiality of data protected Protecting vulnerable subjects and avoiding coercion Beneficence (be good!) May individual participants benefit from the procedures? risks commensurate to benefits Risks minimized, benefits maximized, by design Justice (be fair!) Who is asked to participate? Who excluded? Burdens and benefits distributed equitably
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45 CFR 46, aka “Common Rule” Established in 1981 by DHHS Most recent revision 2005 Lays out the regulatory territory: What is research? What is exempt / expeditable? What is the structure of the IRB’s?
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This note was uploaded on 12/02/2009 for the course PPE 4412 taught by Professor Rice during the Spring '09 term at University of Florida.

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IRB Overview - Research Protections for Human Participants:...

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