by Elisa A. Hurley, PhD, Executive Director, and Avery Avrakotos, Education and Policy Manager
The biomedical research landscape has evolved dramatically since the publication of the federal regulations for the protection of human subjects in 1974. In particular, research with human subjects has become an increasingly complex endeavor in which multi-center rather than institution-based research is increasingly the norm. In light of this shift, it is sensible to consider whether an alternative structure for research review better safeguards the rights and welfare of research participants and lessens unnecessary administrative burdens.
In December, the National Institutes of Health (NIH) took a step in this direction with the release of a draft policy aimed at reducing inefficiencies associated with multiple IRB reviews. The policy, titled “Draft Policy on the Use of a Single Institutional Review Board for Multi-Site Research,” calls for all domestic sites participating in NIH-conducted or -supported multi-site studies “to rely on a single IRB to carry out the functions that are required for institutional compliance with IRB review set forth in the [Department of Health and Human Services (DHHS)] regulations for the Protection of Human Subjects.”
Earlier this month, we summarized the changes proposed in the draft policy. Today, we are pleased to share PRIM&R’s response to the draft policy. In our response, we acknowledge that the use of a single IRB can be a beneficial approach for some multi-site studies, but emphasize that it is premature and perhaps inappropriate to mandate single IRB review for all NIH-funded and conducted studies.
PRIM&R believes that, before such a policy is implemented, further reliable empirical evidence is needed on the various ways in which a single IRB can be used to provide ethical review of multi‐site research, and on whether such review is better, from the perspectives of subject protections, administrative costs, efficiency, and quality of review, than relying on local IRBs. In the absence of sufficient evidence, we believe that a policy requiring the use of single IRBs for all domestic sites of multi-site NIH‐funded studies is premature and ill advised.
Furthermore, PRIM&R believes that there are a number of procedural questions and logistical challenges that must be addressed before the adoption of such a policy. To address these issues, again, more time is needed to conduct research on the use of single IRBs, to develop guidance for institutions and IRBs, and to disseminate best practices.
Instead of mandating single IRB review for all NIH-funded studies at this time, PRIM&R urges the NIH to consider offering incentives to encourage voluntary adoption of single IRB review, and suggests several activities that the NIH could pursue in order to support the wider use of the single IRB mechanism for multi‐site studies:
- Convene an expert panel to host open meetings to develop criteria regarding the types of research that lend themselves to the single IRB model and those that do not;
- Sponsor research on existing models of review by a single IRB for multi‐site research to gather more evidence about both the quality and cost of review;
- Create incentives (e.g., preferential treatment in the award process) that encourage and reward the use of, and require the collection of data on the use of, single IRB review and/or elements of single IRB review processes; and
- Develop tools, guidance, and best practices to help facilitate the use of single IRB review mechanisms (e.g., model reliance agreements, standard operating procedures, etc.)
As a final point, we share concerns about how the adoption of provisions originally proposed in the DHHS’ 2011 Advance Notice of Proposed Rulemaking may perpetuate a piecemeal approach to regulatory change and undermine harmonization amongst regulatory requirements from different funding agencies.
We encourage you to read PRIM&R’s complete response to the NIH, and to share your thoughts about PRIM&R’s comments or the NIH’s draft policy below.