Human Research Report Digital Newsletter

Protecting Research Subjects and Researchers

Vol. 37, No. 9, Sept., 2022

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Here’s an inside look at what you will receive in the digital newsletter, including an additional excerpt, below. Click the image below for the first two pages of this issue.

Back Issue September 2022

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Excerpt from pg. 3 … The Use of a Single IRB in Cooperative Research (#2)

We continue this month with more advice for IRBs from the recent guidance from the Office for Human Research Protections (OHRP) titled “Use of a Single Institutional Review Board for Cooperative Research Draft.”

We resume where we left off last month with Frequently Asked Question (FAQ) #6 (“Are there documentation requirements for use of a single IRB in cooperative research?”).


Yes. The relying institution and the organization operating the single IRB must document the institution’s reliance on the single IRB and the responsibilities of each entity with respect to ensuring compliance with the 2018 Requirements (45 CFR 46.103(e)) (guidance, July 1; on the Web at https://www.hhs.gov/ohrp/regulations-and-policy/requests-for-comments/draft-guidance-use-single-institutional-review-board-for-cooperative-research/index.html).

Numerous Duties for Single IRBs

However, the regulations do not prescribe how such documentation must be accomplished.

There is flexibility in how this might be done: for example, through a written agreement between the institution and the single IRB, through implementation of a institution-wide policy directive outlining the allocation of responsibilities between the single IRB and the institution, or through a description in the IRB-approved research protocol (§46.103(e)).

Reliance agreements may cover one protocol, multiple protocols, or all research within a certain set of parameters. …