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  • Washington Highlights

    AAMC Submits Comments on Proposed Policy to Streamline IRB Review of Domestic Multi-site Clinical Studies

    Heather Pierce, Senior Director, Science Policy & Regulatory Counsel

    The AAMC Jan. 29 submitted a letter to the National Institutes of Health (NIH) in response to a Dec. 3, 2014, request for comments on a draft policy requiring 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 goal of increasing use of a single IRB for multi-site trials is to “enhance and streamline the process of IRB review and reduce inefficiencies so that research can proceed efficiently without compromising ethical principles and protections.”

    Under the draft policy, the IRB of record would be accountable for providing initial and continuing review of the research in compliance with the applicable regulatory requirements. All participating sites would be responsible for meeting the other obligations, such as obtaining informed consent from human subjects, overseeing the implementation of approved protocols, and reporting unanticipated problems and adverse events to the single IRB of record. With the appropriate justification, exceptions are allowed only if the designated IRB is unable to meet the needs of specific populations or where local IRB review is required by law.

    In its Jan. 29 comment letter, the AAMC urges NIH to use the results from research on central IRBs that it has recently announced it will fund to inform the implementation of a broader requirement to use single IRBs. The association also recommends that NIH take interim actions, such as:

    • Run a pilot program to measure the true costs, benefits, and consequences of greater adoption of single IRBs;
    • Issue a policy with incentives for voluntary adoption;
    • Limit the policy to studies that would most benefit from a single IRB; and
    • Create or fund resources and tools that facilitate collaboration, cooperation and greater efficiencies among study sites.

    The AAMC letter states that “despite our support for the increased use of single IRBs for multi-site trials, we believe that the implementation of this policy as drafted will not accomplish the NIH’s laudable goals, but may instead increase costs, shift administrative burdens, and encourage the development of 'shadow' IRB reviews to fill in the gaps left by insufficient guidance on how to create many simultaneous reliance agreements and relationships.”