Open AccessTransitioning to the National Institutes of Health single institutional review board model: Piloting the use of the Streamlined, Multi-site, Accelerated Resources for Trials IRB Reliance
Author(s) -
Orly Vardeny,
Adrian F. Hernandez,
Lauren W. Cohen,
Amy Franklin,
Mina Baqai,
Sarah Jane Palmer,
Barbara E. Bierer,
Nichelle Cobb
Publication year - 2019
Publication title -
clinical trials
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.559
H-Index - 63
eISSN - 1740-7753
pISSN - 1740-7745
DOI - 10.1177/1740774519832911
Subject(s) - institutional review board , clinical trial , medicine , family medicine , pathology , surgery
Obtaining ethical approval from multiple institutional review boards is a long-standing challenge to multi-site clinical trials and often leads to significant delays in study activation and enrollment. As of 25 January 2018, the National Institutes of Health began requiring use of a single institutional review board for US multi-site trials. To learn more and further inform the research and regulatory communities around aspects of transitioning to single institutional review board review, this study evaluated the efficiency, resource use, and user perceptions of a nascent institutional review board reliance model (Streamlined, Multi-site, Accelerated Resources for Trials IRB Reliance).