Single IRBs in Multisite Trials: Questions Posed by the New NIH Policy
Document Type
Journal ArticlePublication Date
2017-05-23Keywords
institutional review boardIRB
clinical trials
multisite
NIH research
Bioethics and Medical Ethics
Medicine and Health Sciences
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Show full item recordAbstract
Of all the issues raised by the NIH single-IRB policy, the relationship between the single IRB and the participating sites is possibly the most complex. There are 3 critical aspects that academic institutions, researchers, and policy makers will have to resolve before implementation of the new policy: (1) the relationship between the single IRB and the local institutions, including the local IRBs; (2) the collection and incorporation of local knowledge in the single-IRB review; and (3) the relationship between the single IRB and local researchers. These issues involve fundamental legal, ethical, institutional, and policy tensions that will profoundly shape the costs and effectiveness of future multisite research involving human research participants.Source
JAMA. 2017 May 23;317(20):2061-2062. doi: 10.1001/jama.2017.4624. Link to article on publisher's siteDOI
10.1001/jama.2017.4624Permanent Link to this Item
http://hdl.handle.net/20.500.14038/29116PubMed ID
28445582Related Resources
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Publisher PDF posted after 6 months as allowed by the publisher's author rights policy at http://jamanetwork.com/journals/jama/pages/instructions-for-authors#SecDepositingResearchArticlesinApprovedPublicRepositories.ae974a485f413a2113503eed53cd6c53
10.1001/jama.2017.4624