Pediatric specific challenges of the single institutional review board mandate

Abstract

Background: The Common Rule Revision (CRR) mandates a single institutional review board (IRB) for all US federally funded nonexempt multisite human participant research. While the CRR aims to improve research efficiency, its success in pediatric research remains uncertain Main body: There are multiple challenges that threaten the purported efficiency of the single IRB mandate. While the CRR is clear that ethical review is the purview of the single IRB, responsibility for issues of local study governance are less well defined. Therefore, reliance agreements (RA) must be negotiated between single IRBs and participating institutions. These negotiations can vary significantly based upon the institution’s local context and are often arduous, lengthy, and burdensome. Furthermore, in pediatric research, issues such as assent, surrogate consent, and IRB risk determination add additional layers of complexity that must be considered. No clear system exists for resolving disagreements surrounding these critical human participant protection issues. Finally, the variation in institutional resources directed towards pediatric research may mean that only a select few pediatric institutions will be able to function in the single IRB system. These challenges will need to be overcome to successfully implement the CRR and achieve its objective of improving multisite research efficiency. We suggest that an empiric and collaborative approach utilizing implementation strategies is necessary for the CRR and single IRBs to be effective. Conclusion: The CRR seeks to improve the efficiency of multisite human participant research in the US. There are multiple challenges that will need to be overcome. An empiric collaborative approach is necessary. If successful, single IRBs have the potential to usher in a new era of impactful and efficient multisite pediatric research.