NPRM-2015-Significant Change #6: Single IRB review

Significant change to the Common Rule proposed in the NPRM: Single IRB review

After years of debate and speculation, sixteen federal agencies have collaborated on a notice of proposed rulemaking (NPRM) with the stated purpose of modernizing, strengthening, and making more effective the federal policy for the protection of human subjects. While the NPRM does not tackle as many issues as the Advanced Notice of Proposed Rulemaking (ANPRM) of July 2011, it nevertheless proposes a number of bold moves to streamline the clinical trial process. The U.S. Department of Health and Human Services has identified eight of the proposed changes as “most significant.” The following is the sixth of these significant changes and a brief description prepared by Quorum Review’s regulatory attorneys:

Change proposed in the NPRM

Mandate that U.S. institutions engaged in cooperative research rely on a single IRB for that portion of the research that takes place within the United States, with certain exceptions. To encourage the use of IRBs that are otherwise not affiliated with or operated by an assurance-holding institution (“unaffiliated IRBs”), this NPRM also includes a proposal that would hold such IRBs directly responsible for compliance with the Common Rule.

Quorum’s description of the proposed change

One of the boldest proposals of the NPRM is to mandate that only one IRB can act as the IRB of record for U.S. sites participating in a multi-site study.  Policymakers have been encouraging this change for years, and the National Institutes of Health presaged this proposal late last year by publishing draft policy that promotes the use of a single IRB of record for multi-site NIH studies.[1]  The proposed regulation specifies that the funding department or agency would be responsible for choosing the IRB of record, and for studies with no funding agency the lead institution conducting the research would be responsible.[2]

Under the proposed rules, the requirement for a single IRB of record would not apply to: (1) cooperative research for which more than single IRB review is required by law (e.g., FDA-regulated devices); or (2) research for which the Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular study.[3]  The NPRM acknowledges that many institutions will have to implement policy and procedure changes in order to be able to outsource ethics review to a single IRB of record.  For this reason, the NPRM proposes that the requirement for a single IRB of record should not take effect for three years from publication of the final rule.[4]

Read all the changes

Click here to read all of the significant changes to the Common Rule proposed in the NPRM.

[1] See, Request for Comments on the Draft NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research (Dec. 3, 2014)

[2] NPRM at §¬__.114(b)(1)

[3] NPRM at §__.114(b)(2)

[4] NPRM, p. 53984

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