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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 Releases Final Policy on the Use of a Single Institutional Review Board for Multi-Site Research

June 24, 2016— The National Institutes of Health (NIH) June 21 released a final policy requiring the use of a single Institutional Review Board (IRB) of record for all domestic sites participating in agency-funded multi-site clinical trials.

Under the policy, a single IRB (sIRB) of record will be accountable for conducting the initial and continuing ethical review of NIH-funded non-exempt human subjects research carried out at more than one clinical trial site in the United States. Participating sites remain responsible for meeting other regulatory requirements with respect to research conducted at their own institutions, such as obtaining informed consent, overseeing implementation of approved protocols, and communicating with the IRB of record.

This policy is “intended to enhance and streamline the process of IRB review and reduce inefficiencies so that research can proceed as expeditiously as possible without compromising ethical principles and protections for human research participants.”

The AAMC submitted a comment letter to NIH in response to the draft policy [see Washington Highlights, Jan. 30, 2015]. While recognizing the potential benefits of single IRB review for multi-site trials, the AAMC noted that implementation of 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.”

According to NIH, “The policy will begin a paradigm shift in IRB review” and therefore, the final policy will take effect on May 25, 2017. In the interim, NIH has provided guidance materials and resources to assist the research community with implementation of the policy. Additional materials will be added when available.

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