Reviewing the FDA’s Proposed Single IRB Mandate

While the FDA has proposed acceptance of the first exception, it has not proposed adoption of the second exception from the Common Rule because the FDA does not support or conduct the research that it oversees through regulations 21 CFR 50 and 56. Therefore, FDA has declined to include this exception in the NPRM.

However, FDA is proposing three additional exceptions that were not included in the Common Rule. The first unique exception is:

Cooperative research involving a highly specialized FDA-regulated medical product for which unique, localized expertise is required;

The other two unique exceptions are for clinical investigations with drugs and biologics that do not require an IND and for clinical investigations of medical devices that do not require an IDE:

Cooperative research on drugs that meets the exemptions from an investigational new drug application under § 312.2(b) of this chapter; or
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.²

Potential Impact of the Unique Exceptions

This first unique exception is unlikely to apply very often.  No definition is provided for a “highly specialized FDA-regulated medical product” or “unique, localized expertise.”  In addition, individual or entity who makes this decision is not identified. Also, studies that are this unique would likely be single site studies in the first place.

The second and third unique exceptions, for IND and IDE exempt clinical investigations, may be used occasionally. These types of studies are often small in size and often do not have commercial sponsorship. Also, a single IRB could be utilized, even if not required under the new regulation.

These three unique exemptions have the potential to create regulatory conflicts for research that is both FDA-regulated and federally-funded; and thus, it would be subject to the Common Rule. For instance, if an NIH funded study qualified for one of the three unique exceptions in the FDA regulation, there would be conflicting regulatory requirements with the Common Rule.

Because the Common Rule does not include these provisions, the Common Rule would still require single IRB review unless the NIH took action under 45 CFR 46.114(b)(2)(ii) to determine that “[research] for which any 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 context.”⁴

While these regulatory conflicts would create some additional regulatory burden, it will not be unmanageable for the regulated community.

Conclusion

IRBs, institutions, and investigators involved in the review and conduct of federally-funded research have already adopted the single IRB requirement as it was implemented in 2018 in the Common Rule. On the other hand, those institutions and investigators who only conduct FDA regulated research will need to review their policies and ensure they are prepared for compliance with this requirement, particularly at institutions with local IRBs.

Commercial sponsors and CROs should be prepared to address this new requirement if and when it is implemented, although the change should lead to less administrative burden on sponsors and CROs as only one IRB will review each study. That said, the timeline for adoption of these proposed changes to the FDA regulations is unclear; it could take several months or even several years. However, forward thinking sponsors, institutions and investigators may want to start updating their policies now.