COGR Submits Comments/Questions to NIH on "Single IRB Policy FAQs for Extramural Community"

The document provides a detailed overview of the NIH Single Institutional Review Board (sIRB) Policy as it applies to extramural research communities, particularly focusing on its implementation in multi-site, NIH-funded studies. The policy, enacted to streamline IRB review processes and reduce redundancies, mandates that domestic sites conducting the same non-exempt human subjects research protocol rely on a single IRB of record, rather than duplicate reviews at each site. This approach is intended to improve efficiency, reduce administrative burden, and maintain robust protections for research participants. The policy applies to all funding mechanisms—including grants, contracts, cooperative agreements, and specific awards like SBIR/STTR—except for training, fellowship, and career development awards. Foreign sites and certain domestic sites governed by federal, state, or Tribal regulations are generally exempt or eligible for exceptions.

The document delineates operational aspects such as the definition and selection of a single IRB, reliance agreements, roles and responsibilities of both the IRB and participating sites, and timelines for IRB compliance relative to awards. It emphasizes the necessity for formal Reliance Agreements among participating institutions and outlines the reporting and communication requirements inherent to single IRB oversight. Key considerations for institutions include managing budgeting challenges related to IRB review costs, addressing local context, and ensuring clear operational delegation. The policy encourages proactive planning and inter-institutional communication but allows for flexibility and exceptions under specific legal, regulatory, or ethical circumstances. Overall, the FAQs clarify policy application, compliance obligations, and practical implementation challenges, aiming to balance human subjects protection with the need for efficient study initiation and management in multi-site research.