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Second Opinion

Learn about policy issues important to medical schools and teaching hospitals, with Executive Vice President Atul Grover, M.D., Ph.D.

Washington Highlights

AAMC Joint Letter Requesting an Extension to the NIH Single IRB Policy

October 28, 2016—The AAMC Oct. 24 joined the Association of American Universities, the Association of Public and Land Grant Universities, and the Council on Government Relations in a letter to National Institutes of Health (NIH) Deputy Director for Extramural Research, Michael Lauer, MD, and NIH Associate Director for Science Policy and Director of the Office of Science Policy, Carrie Wolinetz, PhD. The letter requested a one-year extension to the implementation date of the NIH Policy on the Use of a Single Institutional Review Board (IRB) for Multi-Site Research (sIRB Policy), scheduled to take effect on May 25, 2017.

The NIH on June 21, 2016, released the final sIRB Policy which requires the use of a single IRB of record for all domestic sites participating in agency-funded multi-site clinical trials. The AAMC submitted a comment letter to NIH in response to the draft policy [see Washington Highlights, Jan. 30, 2015] which recognized the potential benefits of single IRB review but also noted that the policy as drafted “could increase costs, shift administrative burdens, and encourage the development of ‘shadow’ IRB reviews to fill in the gaps led by insufficient guidance on how to create many simultaneous reliance agreements and relationships.”

Signatories to the letter expressed significant concerns about the logistics involved in implementing the final policy which is just seven months away. The letter adds, “[i]nstitutions are currently laying the groundwork to implement the NIH sIRB Policy. This includes assessing the capacity to act as the reviewing IRB; assessing what IT, personnel and operational changes will have to be made and cost analyses; developing SOPs, forms, checklists, processes; educating staff; and establishing fee schedules or, for those seeking to partner with a commercial IRB, working with that IRB to develop processes and fees.” Given many institutions are still uncertain about how to implement this policy, the letter notes that additional time is needed to “ensure that the NIH Single IRB Policy is implemented in a measured and thoughtful manner and will facilitate a successful transition to the policy.”

Contact:

Heather Pierce, JD, MPH
Sr. Director, Science Policy & Regulatory Counsel
Telephone: 202-478-9926
Email: hpierce@aamc.org

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Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org