Using central IRBs for multicenter clinical trials in the United States. PLoS One 2013;8(1):e54999
Date
02/06/2013Pubmed ID
23383026Pubmed Central ID
PMC3559741DOI
10.1371/journal.pone.0054999Scopus ID
2-s2.0-84873849027 (requires institutional sign-in at Scopus site) 61 CitationsAbstract
Research institutions differ in their willingness to defer to a single, central institutional review board (IRB) for multicenter clinical trials, despite statements from the FDA, OHRP, and NIH in support of using central IRBs to improve the efficiency of conducting trials. The Clinical Trials Transformation Initiative (CTTI) supported this project to solicit current perceptions of barriers to the use of central IRBs and to formulate potential solutions. We held discussions with IRB experts, interviewed representatives of research institutions, and held an expert meeting with diverse stakeholder groups and thought leaders. We found that many perceived barriers relate to conflating responsibilities of the institution with the ethical review responsibilities of the IRB. We identified the need for concrete tools to help research institutions separate institutional responsibilities from ethical responsibilities required of the IRB. One such tool is a document we created that delineates these responsibilities and how they might be assigned to each entity, or, in some cases, both entities. This tool and project recommendations will be broadly disseminated to facilitate the use of central IRBs in multicenter trials. The ultimate goal is to increase the nation's capacity to efficiently conduct the large number of high-quality trials.
Author List
Flynn KE, Hahn CL, Kramer JM, Check DK, Dombeck CB, Bang S, Perlmutter J, Khin-Maung-Gyi FA, Weinfurt KPAuthor
Kathryn Eve Flynn PhD Vice Chair, Professor in the Medicine department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
Clinical Trials as TopicEthics Committees, Research
Humans
Internet
Multicenter Studies as Topic
Patient Advocacy
Trust
United States
