FDA’s Proposed Rule for Single IRB Review in Cooperative Research

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The FDA has released a notice of proposed rulemaking to mandate that any institution located in the United States, participating in FDA-regulated cooperative research, must rely on a single Institutional Review Board (sIRB) for overseeing research conducted in the United States.  (See Institutional Review Boards; Cooperative Research (87 FR 58752)). The proposal aims to harmonize the FDA Institutional Review Board (IRB) regulations with the Federal Policy for the Protection of Human Subjects, known as the “Common Rule”, which currently requires a single IRB review for such research.    

The new FDA regulation will require that “Any institution located in the United States that is participating in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States.”     

To ensure the rule is comprehensive yet pragmatic, the FDA has proposed four exceptions to this requirement:  

1. Cooperative research for which more than a single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe);  
2. Cooperative research involving a highly specialized FDA-regulated medical product for which unique, localized expertise is required;  
3. Cooperative research on drugs exempt from an investigational new drug application, as outlined under § 312.2(b) of this chapter; or  
4. Cooperative research on medical devices that meets the abbreviated requirements under § 812.2(b) of this chapter or that meets the requirements for exempted investigations under § 812.2(c) of this chapter.    

When the FDA adopts this requirement, sponsors will be obligated to use a single IRB for U.S. sites. Previously, this approach was allowed, but not required. Many industry sponsors have voluntarily taken this approach for some time, so disruption at the sponsor level will be minimal. For institutions and investigators, the imposition of the single IRB requirement will likely require some modifications to standard operating procedures (SOPs) and resources in order to comply. Still, many have already taken these steps due to the previous adoption of the Common Rule requirement, thereby facilitating a smoother transition and promoting more harmonization as we move into 2025.  

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