The presentation by Lois Brako and David Wynes addresses the NIH’s draft policy proposing the use of a single Institutional Review Board (IRB) for multi-site, NIH-funded research studies. The policy would mandate that all domestic sites in multi-site studies rely on a single designated IRB to streamline oversight and compliance, with exceptions allowed only when justified by specific regulations or population needs. While the policy aims to reduce redundancies and increase efficiency, Brako and Wynes note several significant concerns. These include the challenges of identifying a capable reviewing IRB, the potential for increased costs and administrative burdens, disruptions to established institutional workflows, and unresolved issues regarding institutional liability. The speakers also highlight that not all IRBs are equipped to scale up or provide adequate protections on a national or international scope.
The authors make several recommendations, advocating for a cautious, targeted implementation of the single IRB model. They support its use in scenarios where a uniform protocol is essential, such as research governed by the National Cancer Institute’s Central IRB (NCI CIRB), and urge that any NIH policy be piloted in these settings before broader adoption. They caution against mandating a “one-size-fits-all” approach, emphasize the importance of minimizing the proliferation of central IRBs, and call for allowances for local IRB involvement in cases of conflict of interest or unique local issues. Furthermore, Brako and Wynes argue that new policy should not be justified by speculative benefits, or precede final regulatory changes to the Common Rule. Overall, while supportive of efforts to enhance oversight efficiency, they stress the need for risk mitigation, practical implementation strategies, and regulatory clarity before widespread adoption of the NIH’s proposed single IRB policy.
