학술논문
A Proposal by the U.S. Food and Drug Administration for Reliance on Single Institutional Review Boards: Proceed Only With Caution.
Document Type
Article
Source
Subject
*INSTITUTIONAL review boards
*REVIEW committees
*CLINICAL trials
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*
Language
ISSN
0003-4819
Abstract
The U.S. Food and Drug Administration has proposed a rule change to mandate that most multisite clinical trials adopt a single institutional review board review instead of having separate reviews for each site. The authors of this commentary examine the expected consequences of implementing this change and make 3 recommendations to minimize unwanted outcomes. [ABSTRACT FROM AUTHOR]