Human_Subjects - ReviewBoards RogerL.Bertholf,Ph.D Chair,...

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    A History of Human Research  Protections and Institutional  Review Boards Roger L. Bertholf, Ph.D. Associate Professor of Pathology Chair, University of Florida IRB-03
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    The Nuremberg Trials The International Military Tribunal  (1945) The Doctors Trial (1946) The Nuremberg Code (August, 1947)
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    The Nuremberg Code Established necessity of informed  consent Introduced concept of beneficence Introduced the notion of proportionality  between risk and benefit
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    The Declaration of Helsinki Adopted by the World Medical Association in  1964 Provided guidelines for the conduct of human  subjects research Institutional Review Boards “generally accepted scientific principles” Distinction between clinical and basic research Placebo controversy
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    The Tuskegee Syphilis Study PHS initiated syphilis treatment program in  1928 Discovered 35 – 40% infection rate in Macon  County, AL Revised study to observation only Enlisted help of the Tuskegee Institute Terminated in 1972
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    The Belmont Report Drafted by the National Commission for the  Protection of Human Subjects in Biomedical  and Behavioral Research Final version adopted in 1979 Three sections: Clinical practice vs. research Three guiding principles of ethical research Application of the three principles
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  Clinical practice vs. research What is the purpose of the activity? Are results generalizable?
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This note was uploaded on 09/18/2011 for the course MED 6566 taught by Professor Staff during the Summer '11 term at University of Florida.

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Human_Subjects - ReviewBoards RogerL.Bertholf,Ph.D Chair,...

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