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    Single IRBs in Multisite Trials: Questions Posed by the New NIH Policy

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    Authors
    Klitzman, Robert
    Pivovarova, Ekaterina
    Lidz, Charles W.
    UMass Chan Affiliations
    Systems and Psychosocial Advances Research Center
    Department of Psychiatry
    Document Type
    Journal Article
    Publication Date
    2017-05-23
    Keywords
    institutional review board
    IRB
    clinical trials
    multisite
    NIH research
    Bioethics and Medical Ethics
    Medicine and Health Sciences
    
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    Abstract
    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 site
    DOI
    10.1001/jama.2017.4624
    Permanent Link to this Item
    http://hdl.handle.net/20.500.14038/29116
    PubMed ID
    28445582
    Related Resources

    Link to Article in PubMed

    Rights
    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
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