简化伦理审查。
Streamlining ethical review.
机构信息
Clinical Center Department of Bioethics and Fogarty International Center, National Institutes of Health, Bethesda, MD 20892-1156, USA.
出版信息
Ann Intern Med. 2010 Nov 16;153(10):655-7. doi: 10.7326/0003-4819-153-10-201011160-00008.
The review system for human subjects research in the United States has been widely criticized in recent years for requirements that delay research without improving human subject protections. Any major reformulation of regulations may take some time to implement. However, current regulations often allow for streamlined ethics review that does not jeopardize-and may improve-protections for research participants. The authors discuss underutilized options, including research that need not be classified as human subjects research, categories of studies that can be exempt from ethical review, studies that need only undergo expedited review by 1 institutional review board (IRB) member, and simplifying reviews of multicenter research by using the IRB of 1 institution. The authors speculate on multiple reasons for the underuse of these mechanisms and exhort IRBs and researchers to take advantage of these important opportunities to improve the review process.
近年来，美国的人体研究审查制度因其要求在没有改善人体保护的情况下延迟研究而受到广泛批评。任何对法规的重大修订都需要一些时间来实施。然而，现行法规通常允许简化伦理审查，既不会危及——反而可能改善——研究参与者的保护。作者讨论了未充分利用的选择，包括无需被归类为人体研究的研究、可豁免伦理审查的研究类别、只需由 1 名机构审查委员会（IRB）成员进行快速审查的研究，以及通过使用 1 个机构的 IRB 简化多中心研究的审查。作者推测了这些机制未被充分利用的多种原因，并敦促 IRB 和研究人员利用这些重要机会来改进审查过程。
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