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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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