The Role of Controversial Research in the IRB's Risk/Benefit Analysis

11:5 The American Journal of Bioethics 14 (2011)

5 Pages Posted: 27 Mar 2013

See all articles by John Lunstroth

John Lunstroth

UNESCO Chair in Bioethics and Human Rights; University of Houston

Date Written: April 29, 2011

Abstract

When an institutional review board (IRB) is asked to approve potentially controversial research, such as research into genetic enhancement or harm reduction in illegal activities, is it prohibited from considering the long-range sociopolitical effects of the research in its risk/benefit analysis? I evaluate the history of the Common Rule (45 CFR 46) to answer this question, and on the way discuss the problem of non-lawyer bioethicists and medical scientists interpreting legal documents such as 45 CFR 46.

Keywords: IRB, human research, regulation of human experimentation, 45 CFR 46, risk-benefit analysis in human subjects research, risk-benefit analysis

Suggested Citation

Lunstroth, John and Lunstroth, John, The Role of Controversial Research in the IRB's Risk/Benefit Analysis (April 29, 2011). 11:5 The American Journal of Bioethics 14 (2011), Available at SSRN: https://ssrn.com/abstract=2239877

John Lunstroth (Contact Author)

University of Houston

4800 Calhoun Road
Houston, TX 77204
United States

UNESCO Chair in Bioethics and Human Rights ( email )

2255 JEAN ST
HOUSTON, TX 77023-5008
United States
7134120077 (Phone)

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