Single IRB and IRB Authorization Agreements

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Office for Research Protections     |     Institutional Review Board

Effective January 20, 2020, the Office for Human Research Protections (OHRP) revised Common Rule requires a single IRB review (sIRB) for all engaged domestic sites participating in a non-exempt, cooperative research study. Cooperative research studies are those projects covered by this policy that involve more than one institution, such as when two or more institutions coordinate to complete a portion of the research outlined in a specific protocol (45CFR 46.114). This requirement does not apply to those studies that were reviewed and approved by the PSU IRB prior to the effective date. 

Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States. The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research.

Of note, if Penn State is the prime awardee on a federal grant, Penn State is automatically engaged in human subjects research – even if all human subjects work is done at another institution. Therefore, Penn State would need to enter into an authorization agreement with a collaborating institution's IRB to meet the sIRB requirement. 

At Penn State, only the Office for Research Protections is permitted to enter the IRB into an authorization agreement; investigators do NOT have the authority to enter into an authorization agreement.

Most questions regarding sIRB must be answered on a case-by-case basis as there are a multitude of factors impacting the IRB’s decision to enter into an authorization agreement for sIRB review. Review by a sIRB does not eliminate the need for researchers to communicate with their local institutional IRB, submit required materials and information, and complete institutional training and ancillary review requirements: even when relying on an external IRB, Penn State researchers are still required to submit certain information to the Penn State IRB.

Visit our webpage on Single IRB and Reliance Agreements for more information on how to initiate a reliance arrangement and on the NIH requirement for sIRB review of multi-site research. The Office for Research Protections will host a presentation “Understanding Single IRB: 20-Minute Overview” on March 5 at 3 PM in 102 Kern and remotely via Zoom. No registration required. Click the Zoom link provided to attend remotely. An IRB analyst will be available for questions.