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A Proposed Process for Reliably Updating the Common Rule.
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- Author(s): Berkman BE;Berkman BE; Wendler D; Wendler D; Sullivan HK; Sullivan HK; Grady C; Grady C
- Source:
The American journal of bioethics : AJOB [Am J Bioeth] 2017 Jul; Vol. 17 (7), pp. 8-14.- Publication Type:
Journal Article- Language:
English - Source:
- Additional Information
- Source: Publisher: Taylor & Francis Country of Publication: United States NLM ID: 100898738 Publication Model: Print Cited Medium: Internet ISSN: 1536-0075 (Electronic) Linking ISSN: 15265161 NLM ISO Abbreviation: Am J Bioeth Subsets: MEDLINE
- Publication Information: Publication: <2008- > : Philadelphia, Pa. : Taylor & Francis
Original Publication: Cambridge, Mass. : MIT Press, c2001- - Subject Terms: Ethics Committees, Research*/legislation & jurisprudence ; Ethics Committees, Research*/trends ; Research Personnel*/trends; Biomedical Research/*ethics ; Human Experimentation/*ethics; Biomedical Research/legislation & jurisprudence ; Ethics, Research ; Human Experimentation/legislation & jurisprudence ; Humans ; Informed Consent ; Quality Assurance, Health Care ; Research Subjects ; Social Responsibility ; United States ; Vulnerable Populations
- 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 (ANPRM) and notice of proposed rulemaking (NPRM). Furthermore, the revision process did not even attempt to tackle any of the Common Rule subparts pertaining to vulnerable populations (i.e., pregnant women and fetuses, prisoners, children) 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 (and expeditious) 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.
- Comments: Comment in: Am J Bioeth. 2017 Jul;17(7):43-46. (PMID: 28661756)
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- Contributed Indexing: Keywords: Common Rule; framework legislation; public consultation
- Publication Date: Date Created: 20170630 Date Completed: 20190612 Latest Revision: 20230926
- Publication Date: 20240104
- Accession Number: PMC6010315
- Accession Number: 10.1080/15265161.2017.1329478
- Accession Number: 28661730
- Source:
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