A Proposed Process for Reliably Updating the Common Rule

American Journal of Bioethics 17 (7):8-14 (2017)

Abstract
The recent Common Rule revision process took almost a decade and the resulting changes are fairly modest, particularly when compared to the ambitious ideas proposed in the advance notice of proposed rulemaking and notice of proposed rulemaking. Furthermore, the revision process did not even attempt to tackle any of the Common Rule subparts pertaining to vulnerable populations where commentators think the rules unduly restrict important research. We believe that this was a missed opportunity to make desirable changes, and that given the usual process the next opportunity to revisit the Common Rule is unacceptably remote. In this article, we argue that the Common Rule should be regularly reassessed, with a mechanism for making substantive changes. Drawing on lessons learned from the recent revision process, we make recommendations about ways to structure future attempts to maximize the ability to make timely and necessary changes.
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DOI 10.1080/15265161.2017.1329478
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The Second Wave: Toward Responsible Inclusion of Pregnant Women in Research.Anne Drapkin Lyerly, Margaret Olivia Little & Ruth Faden - 2008 - Ijfab: International Journal of Feminist Approaches to Bioethics 1 (2):5-22.
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The Impact of HIV Infection on Society's Perception of Clinical Trials.Robert J. Levine - 1994 - Kennedy Institute of Ethics Journal 4 (2):93-98.

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