To Protect Human Subjects, Review What Was Done, Not Proposed

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Science  30 Mar 2012:
Vol. 335, Issue 6076, pp. 1576-1577
DOI: 10.1126/science.1217225

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The Advance Notice of Proposed Rulemaking (ANPRM) released in 2011 by the U.S. Department of Health and Human Services (HHS) (1) recommends many important changes to federal regulations on protection of human research subjects. Perhaps most important, through the 74 questions it poses, it offers the opportunity to rethink approaches to research oversight. The current regulatory model of prospective review, based on what researchers say they plan to do, focuses the attention of Institutional Review Boards (IRBs, which must approve proposed research) and researchers on perfecting protocols and consent forms rather than interacting with subjects. Such a regulatory model may discourage innovation in human subjects protection. In contrast, we describe how a system based on retrospective, auditlike review of a subset of projects could stimulate assessment of the effectiveness of current approaches and the development of creative alternatives, with efficiencies for all concerned.