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
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
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