University of Massachusetts Medical School Faculty Publications

UMMS Affiliation

Department of Psychiatry; Systems and Psychosocial Advances Research Center

Publication Date

5-23-2017

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. Citation: JAMA. 2017 May 23;317(20):2061-2062. doi: 10.1001/jama.2017.4624. Link to article on publisher's site

Related Resources

Link to Article in PubMed

Journal/Book/Conference Title

JAMA

PubMed ID

28445582

Share

COinS
 
 

To view the content in your browser, please download Adobe Reader or, alternately,
you may Download the file to your hard drive.

NOTE: The latest versions of Adobe Reader do not support viewing PDF files within Firefox on Mac OS and if you are using a modern (Intel) Mac, there is no official plugin for viewing PDF files within the browser window.