Single IRBs in Multisite Trials: Questions Posed by the New NIH Policy
UMass Chan AffiliationsSystems and Psychosocial Advances Research Center
Department of Psychiatry
Document TypeJournal Article
Keywordsinstitutional review board
Bioethics and Medical Ethics
Medicine and Health Sciences
MetadataShow full item record
AbstractOf 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.
SourceJAMA. 2017 May 23;317(20):2061-2062. doi: 10.1001/jama.2017.4624. Link to article on publisher's site
Permanent Link to this Itemhttp://hdl.handle.net/20.500.14038/29116
RightsPublisher 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.