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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

NIH Delays Implementation Date for Single IRB Policy

December 16, 2016—National Institutes of Health (NIH) Director Francis Collins, MD, PhD, Dec. 8 announced at the NIH Advisory Committee to the Director meeting that the implementation date for the NIH Policy on the Use of a Single Institutional Review Board (IRB) for Multi-Site Research will be delayed until Sept. 25, 2017. The delay gives institutions an additional four months before the policy takes effect. 

The announcement was in response to an AAMC, Association of American Universities (AAU), Association of Public and Land Grant Universities (APLU), and Council on Government Relations (COGR) Oct. 24 joint letter requesting a delay in implementation of the Single IRB policy [see Washington Highlights, Oct. 28]. The letter highlighted concerns about the time needed to implement the requirements of the final policy such as developing new institutional policies and procedures.

The letter states that institutions need to make assessments regarding “the capacity to act as the reviewing IRB; […] what IT, personnel and operational changes will have to be made and cost analyses; developing SOPs, forms, checklists and 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.” The letter adds that additional time “will 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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Washington Highlights, a weekly electronic newsletter, features brief updates on the latest legislative and regulatory activities affecting medical schools and teaching hospitals.


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