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dc.contributor.authorKlitzman, Robert
dc.contributor.authorPivovarova, Ekaterina
dc.contributor.authorLidz, Charles W.
dc.date2022-08-11T08:08:22.000
dc.date.accessioned2022-08-23T15:52:21Z
dc.date.available2022-08-23T15:52:21Z
dc.date.issued2017-05-23
dc.date.submitted2017-06-23
dc.identifier.citationJAMA. 2017 May 23;317(20):2061-2062. doi: 10.1001/jama.2017.4624. <a href="https://doi.org/10.1001/jama.2017.4624">Link to article on publisher's site</a>
dc.identifier.issn0098-7484 (Linking)
dc.identifier.doi10.1001/jama.2017.4624
dc.identifier.pmid28445582
dc.identifier.urihttp://hdl.handle.net/20.500.14038/29116
dc.description.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.
dc.language.isoen_US
dc.relation<p><a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&list_uids=28445582&dopt=Abstract">Link to Article in PubMed</a></p>
dc.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.
dc.subjectinstitutional review board
dc.subjectIRB
dc.subjectclinical trials
dc.subjectmultisite
dc.subjectNIH research
dc.subjectBioethics and Medical Ethics
dc.subjectMedicine and Health Sciences
dc.titleSingle IRBs in Multisite Trials: Questions Posed by the New NIH Policy
dc.typeJournal Article
dc.source.journaltitleJAMA
dc.source.volume317
dc.source.issue20
dc.identifier.legacyfulltexthttps://escholarship.umassmed.edu/cgi/viewcontent.cgi?article=2345&amp;context=faculty_pubs&amp;unstamped=1
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/faculty_pubs/1342
dc.legacy.embargo2017-11-23T00:00:00-08:00
dc.identifier.contextkey10343922
refterms.dateFOA2022-08-23T15:52:21Z
html.description.abstract<p>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.</p>
dc.identifier.submissionpathfaculty_pubs/1342
dc.contributor.departmentSystems and Psychosocial Advances Research Center
dc.contributor.departmentDepartment of Psychiatry
dc.source.pages2061-2062


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