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Impact of Rules of Ethics vs. Policy on Human Subjects Research MP3

There are similarities and differences between ethical rules and rules of policy when it comes to human subjects research. Benjamin Sachs, assistant professor of environmental studies and bioethics at New York University, discusses his June 2010 article, “The Case for Evidence-Based Rulemaking in Human Subjects Research,” in the American Journal of Bioethics, in which he distinguishes between ethical vs. policy rules and argues that we should acknowledge that most rules are policy rules with no ethical basis. This, he maintains, has resulted in over-regulation of human subjects research and recommends addressing this by enunciating the policy objective and determining whether the policy serves the objective. (July 1, 2010)


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research, human subjects, Benjamin Sachs, rules of ethics, rules of policy, regulation, overregulation

Center for Practical Bioethics

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