NIH Issues Draft Policy That Would Require A Single IRB For Multi-Site Clinical Trials

By Bouvier Grant Group

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For years, grantees have been encouraged to use a shared IRB in multi-site clinical trials as part of shared research networks at NCI, and it appears to increase efficiency without compromising protection. In early December 2014, NIH released a draft policy proposing that multi-site trials in the U.S. be required to use a single IRB. NCI has already conducted an analysis demonstrating that a single IRB decreases time and costs when compared to having individual IRB at each participating clinical site. To read and comment on the draft policy, click here. NIH is eliciting input until January 29, 2015. A commonly used model of joint IRB review is IRBshare, which according to its website “facilitates the sharing of full board approved documents between IRBs, accelerates the initial review process by enabling a temporary reliance between IRBs, and minimizes the need for all sites to conduct a full board review.” See the IRBshare website for details.

Author:
Dr. Meg Bouvier

Margaret Bouvier received her PhD in 1995 in Biomedical Sciences from the Mount Sinai School of Medicine. After an NINDS post-doctoral fellowship, she worked as a staff writer for long-standing NIH Director Dr. Francis Collins in the Office of Press, Policy, and Communications for the Human Genome Project and NHGRI. Since 2007, Meg has specialized in editing and advising on NIH submissions, and began offering virtual courses in 2015. She's recently worked with more than 40% of the nation's highest-performing hospitals*, four of the top 10 cancer hospitals, three of the top five medical schools for research, and 14 NCI-designated cancer centers. Her experience at NIH as both a bench scientist and staff writer greatly informs her approach to NIH grantwriting. She has helped clients land over half a billion in federal funding. Bouvier Grant Group is a woman-owned small business.

*Our clients include 9 of the top 22 hospitals as recognized by the 2023/24 US News & World Report honor roll

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