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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 Proposed Policy to Streamline IRB Review of Domestic Multi-site Clinical Studies

December 5, 2014—The National Institutes of Health (NIH) Dec. 3 released a draft policy (NOT-OD-15-026) to require the use of a single Institutional Review Board (IRB) of record for all domestic sites of multi-site clinical trials conducted or supported by NIH.

The draft policy intends to “enhance and streamline the process of IRB review and reduce inefficiencies so that research can proceed efficiently without compromising ethical principles and protections.” The AAMC supported the adoption of a regulatory framework that promotes and facilitates the use of a single IRB for multi-site studies in its response to a July 26, 2011 Department of Health and Human Services (HHS) advance notice of proposed rulemaking.

In the draft policy, the IRB of record would be accountable for providing initial and continuing review of the research in compliance with HHS regulatory requirements. The draft policy also requires each institution to have IRB Authorization Agreements that document the responsibilities of the IRB of record and of the participating site. Each study site would retain the regulatory obligations for obtaining informed consent from human subjects enrolled at that site, overseeing and implementing approved protocols, and reporting unanticipated problems and adverse events to the IRB of record.

NIH encourages comments on any aspect of the draft policy. Responses must be submitted via email to SingleIRBpolicy@mail.nih.gov by Jan. 29, 2015.

Contact:

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

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For More Information

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