Research_Ethics - Human Research Ethics Roger L Bertholf Ph.D Associate Professor of Pathology Chief of Clinical Chemistry Toxicology University of

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Human Research Ethics Roger L. Bertholf, Ph.D. Associate Professor of Pathology University of Florida Health Science Center/Jacksonville
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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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Defendants and Defense Counsel 15 of 23 guilty, 7 hanged, 5 life sentences
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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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“Before IRBs, the only consent required was that of a researcher's department head. The Nuremberg Code was ignored in practice. As I look back on it, the interpretation of these codes was that they were necessary for barbarians, but not for fine upstanding people . . .” Dr. William Silverman, Columbia pediatrician, on the postwar mentality
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Jewish Chronic Disease Hospital Brooklyn, 1963 Elderly debilitated patients injected with live cancer cells to study immunologic response (per transplant rejection) Patients not informed of cancer cells investigators did not wish to frighten unnecessarily a priori hypothesis that cells would be readily rejected
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“ . . . the judgment of the investigator is not sufficient as a basis for reaching a conclusion concerning the ethical . . . set of questions.” “The investigator’s judgment must be subject to prior peer review to ensure an independent determination of risks and benefits and . . .voluntary informed consent.” NIH panel that investigated studies at Jewish Chronic Disease Hospital NIH Director James Shannon, endorsed by Surgeon General William Steward, Feb 1966
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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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Philadelphia Enquirer, 1972
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“Ethical lapses are almost never cases of bad people, doing bad things, for no good reason. Rather, they are good people, doing bad things, for good reasons.” Loosely quoting Marcia Angell, MD former Editor-in-Chief, NEJM
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US National Research Act (1974) Established National Commission for Protection of Human Subjects The Belmont Report, 1979 Code of Federal Regulations, 1974, 1981 Institutional Review Boards (IRBs) Common Rule, 1991
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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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Research_Ethics - Human Research Ethics Roger L Bertholf Ph.D Associate Professor of Pathology Chief of Clinical Chemistry Toxicology University of

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