Reform of Clinical Research Regulations

To the Editor: In his Perspective article, Emanuel (Dec. 10 issue) 1 argues that the Notice of Proposed Rulemaking (NPRM) issued by 16 federal agencies in September to revise the Common Rule that governs research with human beings conducted at institutions receiving federal funding 2 may be imperfec...

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Bibliographic Details
Published inThe New England journal of medicine Vol. 374; no. 17; pp. 1693 - 1694
Main Authors Strauss, David H, Hurley, Elisa A, Capron, Alexander M, Emanuel, Ezekiel
Format Journal Article
LanguageEnglish
Published United States Massachusetts Medical Society 28.04.2016
Subjects
Codes of Ethics
Consent
Government Regulation
Human Experimentation - legislation & jurisprudence
Humans
Informed Consent - legislation & jurisprudence
Research Subjects - legislation & jurisprudence
Specimen Handling - ethics
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ISSN0028-4793
1533-4406
DOI10.1056/NEJMc1601327

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Summary:To the Editor: In his Perspective article, Emanuel (Dec. 10 issue) 1 argues that the Notice of Proposed Rulemaking (NPRM) issued by 16 federal agencies in September to revise the Common Rule that governs research with human beings conducted at institutions receiving federal funding 2 may be imperfect but represents the best chance for needed reform. Sound policymaking does not, however, rely on risky experimentation of the sort the NPRM represents. The NPRM is a troublingly incomplete product: internally inconsistent, dependent on untested assumptions, and too inchoate to be ready for promulgation with just some minor editing. The document, which had largely . . .
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ISSN:0028-4793
1533-4406
DOI:10.1056/NEJMc1601327