We’re all familiar with the analogy that policy development is akin to sausage making: you don’t want to see how it’s made. NIH takes a somewhat different approach in that we not only hope stakeholders will join us in the kitchen as policies are developed; we also seek out your suggestions for improving the recipe.
In Dec 2014, NIH posted the draft “Policy on the Use of Single Institutional Review Board (IRB) for Multisite Research” for public comment. (You may recall Dr. Sally Rockey’s RockTalk post discussing the draft policy.) As a result, OSP received, reviewed, and analyzed 167 comments submitted by individuals, entities affiliated with academic institutions, patient advocacy groups, IRBs, private healthcare and research organizations, tribal nations, and the general public. Public Comments on the Single IRB Policy are available on the OSP website.
While the vast majority of comments (~70%) support the use of a single IRB for multi-site research studies, commenters across all demographics also provided very thoughtful recommendations, questions, and concerns. These comments were broad in scope and expressed differing, often conflicting, opinions for NIH to consider. Going back to the sausage-making analogy, if one commenter suggests that you double the amount of cayenne pepper and another one calls for it to be eliminated, you obviously can’t follow both suggestions but it’s clear that the “cayenne pepper issue” may warrant further discussion.
One such issue made clear by the comments received is the strikingly dissimilar understanding of the roles and responsibilities of the site or institution conducting human subjects’ research and the responsibilities of the reviewing IRB with regard to the protection of human subjects. It’s important to keep in mind that through this draft Policy, NIH doesn’t suggest that the primary responsibility for the protection of human subjects may be relinquished by the local investigator or institution; rather, the policy attempts to streamline one component of human research protections, the IRB regulatory review.
While the regulations (at 45 CFR part 46.114 and 21 CFR part 46.114, for those policy wonks following along at home) have always allowed for reliance on an external IRB for multi-site research, recent support from the Office of Human Research Protections (OHRP) (2010 letter) and FDA (2006 guidance) have helped to reduce the fear of regulatory liability when relying on a single IRB.
Several groups including the National Cancer Institute Central IRB (CIRB), Clinical & Translational Science Awards (CTSA) program, and NeuroNext have laid a strong foundation and continue to develop an infrastructure that reduces redundancy and inefficiency in IRB review and approval of multisite research with the goal of bringing promising new treatments to patients more quickly. We look to build on this foundation and the lesson learned in order to address issues of trust and communication between sites/institutions and single IRBs that may be external to their organization.
Cognizant of the diversity of public opinion and logistical challenges involved in operationalizing the draft Policy, we are using the public comments to identify issues that may warrant additional guidance during a transition period after the Policy is effective prior to the required date of full compliance.
Thank you to all who shared your thoughts and perspective through the Public Comment process. Your input is invaluable as NIH moves forward with this important policy – stay tuned as we continue to tweak the recipe…