Implementation of single IRB review for multisite human subjects research: Persistent challenges and possible solutions

Abstract

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.

IRB challenges in multisite studies: A case report and commentary from the Intellectual Disability Supplement to the Irish Longitudinal Study on Ageing (IDS-TILDA)

“…For example, IRBs often held their approvals until other ancillary reviews were completed, such as conflict of interest assessments, contract review, radiation or biological safety reviews, and data security reviews. With a transition to the use of an external single IRB for research, institutions have had to develop new HRPP processes for ensuring that these ancillary reviews are completed before a study can be activated (Ref [1]). Additionally, it has become clear that although single IRB review has the potential to streamline a significant component of the process required to open studies (i.e., ethics review), IRB review was not the only reason and often not the significant reason for such delays (e.g.,Ref [2]).…”

“…An aspect of local context that can be particularly critical for US IRBs to capture in order to adequately protect the rights and welfare of research participants is variation in state laws that can affect research, especially influence risks to participants. The need to collect and apply local context information as part of the ethics review, which sometimes encompasses the outcomes of ancillary reviews, has affected the efficiency of the single IRB model (Ref [1]). Perhaps the article's authors could address how the concept of local context plays out for a multi-site study in Ireland, including whether it is relevant to that system and, if so, how it might parallel or differ from the US approach.…”