Single IRBs in Multisite Trials: Questions Posed by the New NIH Policy
| dc.contributor.author | Klitzman, Robert | |
| dc.contributor.author | Pivovarova, Ekaterina | |
| dc.contributor.author | Lidz, Charles W. | |
| dc.date | 2022-08-11T08:08:22.000 | |
| dc.date.accessioned | 2022-08-23T15:52:21Z | |
| dc.date.available | 2022-08-23T15:52:21Z | |
| dc.date.issued | 2017-05-23 | |
| dc.date.submitted | 2017-06-23 | |
| dc.identifier.citation | JAMA. 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.issn | 0098-7484 (Linking) | |
| dc.identifier.doi | 10.1001/jama.2017.4624 | |
| dc.identifier.pmid | 28445582 | |
| dc.identifier.uri | http://hdl.handle.net/20.500.14038/29116 | |
| dc.description.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. | |
| dc.language.iso | en_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.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. | |
| dc.subject | institutional review board | |
| dc.subject | IRB | |
| dc.subject | clinical trials | |
| dc.subject | multisite | |
| dc.subject | NIH research | |
| dc.subject | Bioethics and Medical Ethics | |
| dc.subject | Medicine and Health Sciences | |
| dc.title | Single IRBs in Multisite Trials: Questions Posed by the New NIH Policy | |
| dc.type | Journal Article | |
| dc.source.journaltitle | JAMA | |
| dc.source.volume | 317 | |
| dc.source.issue | 20 | |
| dc.identifier.legacyfulltext | https://escholarship.umassmed.edu/cgi/viewcontent.cgi?article=2345&context=faculty_pubs&unstamped=1 | |
| dc.identifier.legacycoverpage | https://escholarship.umassmed.edu/faculty_pubs/1342 | |
| dc.legacy.embargo | 2017-11-23T00:00:00-08:00 | |
| dc.identifier.contextkey | 10343922 | |
| refterms.dateFOA | 2022-08-23T15:52:21Z | |
| 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.submissionpath | faculty_pubs/1342 | |
| dc.contributor.department | Systems and Psychosocial Advances Research Center | |
| dc.contributor.department | Department of Psychiatry | |
| dc.source.pages | 2061-2062 |
