University of Massachusetts Medical School Faculty Publications
UMMS Affiliation
Department of Psychiatry; Systems and Psychosocial Advances Research Center
Publication Date
2017-05-23
Document Type
Article
Disciplines
Bioethics and Medical Ethics | Medicine and Health Sciences
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.
Keywords
institutional review board, IRB, clinical trials, multisite, NIH research
Rights and Permissions
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.
DOI of Published Version
10.1001/jama.2017.4624
Source
JAMA. 2017 May 23;317(20):2061-2062. doi: 10.1001/jama.2017.4624. Link to article on publisher's site
Related Resources
Journal/Book/Conference Title
JAMA
PubMed ID
28445582
Repository Citation
Klitzman, Robert; Pivovarova, Ekaterina; and Lidz, Charles W., "Single IRBs in Multisite Trials: Questions Posed by the New NIH Policy" (2017). University of Massachusetts Medical School Faculty Publications. 1342.
https://escholarship.umassmed.edu/faculty_pubs/1342