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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.

Revisions to the Common Rule and NIH policy require the use of a single Institutional Review Board (sIRB) for the review of most federally funded, multisite research, with the intent of streamlining the review process. However, since initial implementation in 2018, many IRBs and institutions continue to struggle with the logistics of implementing this requirement. In this paper, we report the findings of a workshop held in 2022 to examine why sIRB review remains problematic and propose possible solutions. Workshop participants identified several issues as major barriers, including new responsibilities for study teams, persistent duplicative review processes, the lack of harmonization of policies and practices across institutions, the absence of additional guidance from federal agencies, and the need for greater flexibility in policy requirements. Addressing these problems will require providing additional resources and training to research teams, the commitment of institutional leaders to harmonize practice, and policymakers to critically evaluate the requirement and provide flexibility in applicability.

Single IRB (SIRB) consultation resources were established by the Utah Trial Innovation Center to assist and educate investigative teams prior to the submission of funding applications for multisite, cooperative research. Qualitative analysis of the written consultation materials and meeting minutes revealed the most common areas of education needed by investigative teams, including (a) the differences and relationships between the IRB and a Human Research Protection Program (HRPP); (b) the main phases of the SIRB process; and (c) the use of technology platforms for documentation of SIRB review processes. For investigative teams who are inexperienced with using a SIRB, such consultation in the pre-award period is likely to fill in knowledge gaps and improve the study start-up process.

The Trial Innovation Network has established an infrastructure for single IRB review in response to federal policies. The Network’s single IRB (sIRBs) have successfully supported over 70 multisite studies via more than 800 reliance arrangements. This has generated several lessons learned that can benefit the national clinical research enterprise, as we work to improve the conduct of clinical trials. These lessons include distinguishing the roles of the single IRB from institutional Human Research Protections programs, establishing a consistent sIRB review model, standardizing collection of local context and supplemental, study-specific information, and educating and empowering lead study teams to support their sites.

In 2014, the Request for Applications from the National Institutes of Health. (NIH) for continued funding of a multi-site clinical and mechanistic research. Network, Inner City Asthma Consortium (ICAC), called for “efficient IRB review. And approval for multi-center studies” and “IRB approval within 30 days from. Submission”. These requirements were precursors to the NIH policy of single. IRB review for multi-site studies. Here we share our challenges, implementation processes, results, and recommendations, using a single, independent IRB.