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HHS Announces Exception to the Revised Common Rule Single IRB Requirements

December 5, 2019

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Heather Pierce, Sr. Director, Science Policy & Regulatory Counsel
Daria Grayer, SA- Lead Specialist, Science Policy and Regulation

The Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) Nov. 21 announced a determination of exception that it will except two categories of research from the required use of a single Institutional Review Board (sIRB) to review cooperative research under the revised Common Rule [see Washington Highlights, Jan. 19, 2017]. The revised Common Rule requires institutions engaged in cooperative research to use an sIRB to review and approve research conducted at domestic sites (45 CFR 46.114(b)).

HHS’s decision is in direct response to a May 1 joint letter from the AAMC, Association of American Universities, Association of Public- and Land-grant Universities, and the Council on Government Relations that expressed concerns that multisite research studies approved by multiple IRBs after the effective date of the revised Common Rule must have a single IRB of record by Jan. 20, 2020 [see Washington Highlights, April 20, 2018]. The letter further asserted that requiring studies to be re-reviewed by a single IRB after research has already started is contrary to the original intent of the revised regulations and contends that “research will be interrupted, and administrative burden and costs will significantly increase, without benefit to the protection of research participants.”

In consideration of this request, HHS determined that HHS-conducted or -supported research may continue to use multiple IRBs in lieu of an sIRB under the following conditions: an IRB initially approved the research before Jan. 20, 2020; the National Institutes of Health (NIH) single IRB policy does not apply (and the research was approved by an IRB before Jan. 20, 2020); or the NIH excepted the research from the sIRB policy before Jan. 20, 2020.

The HHS exception is applicable as of Nov. 22.

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