Local Knowledge and Single IRBs for Multisite Studies: Challenges and Solutions

Abstract

New federal policies require single IRB review for multisite studies, but many questions remain about how these IRBs will use local knowledge. The findings from our study, the first to examine how single IRBs perceive needs for local knowledge, reveal several challenges. Study respondents identified four potentially relevant types of local knowledge: about culture and linguistics, about geography and socioeconomics, about the researchers, and about the institutions. Such knowledge can potentially be obtained through local sites, but single IRBs may be unaware of potentially relevant local information, and lack of informal relationships may impede single IRBs' reviews and interactions with researchers. While a recent, commonly used, standardized single-IRB form asks three basic questions about local information, our findings suggest potential needs for additional information and, thus, have important implications for practice, policy, and research.

When IRBs Say No to Participating in Research about Single IRBs

“…Because the extent to which these goals are being achieved is unclear, we sought to enroll commercial (that is, for-profit) single IRBs and single IRBs at academic institutions and government agencies in an observational and interview study to assess challenges they face in implementing the new single IRB mandates. In previous publications, we reported findings about how single IRBs address issues about conflicts of interest, 3 local knowledge, 4 and reliance agreements. 5 Here we report findings about single IRBs' willingness or unwillingness to participate in research that investigates how they function.…”

Stakeholder Experiences with the Single IRB Review Process and Recommendations for Food and Drug Administration Guidance

“…At that time, stakeholders believed that the sIRB review process would lead to a lack of representation of the communities where the research would be conducted. Since then, research has shown that concerns about local knowledge may have been overstated 33 . Yet our findings show that stakeholders continue to be concerned and experience difficulties in considering local context.…”

“…34 SMART-IRB provides guidance on entering local context information and concerns in their online reliance agreement systems (SMART-IRB also has other tools to facilitate the sIRB review process). 35 Klitzman et al 36 suggest consideration of the following areas: linguistic and cultural issues, geographic and socioeconomic issues, researcherspecific issues, and institution-specific issues.…”

“…For example, the National Cancer Institute's (NCI's) long‐established sIRB review process requires institutions to complete four worksheets that describe “local context details, including state and local laws, conflict of interest policies, management plans, standard institution language to be added to consent forms, and a description of potential study participant populations and plans to safeguard vulnerable populations.” 34 SMART‐IRB provides guidance on entering local context information and concerns in their online reliance agreement systems (SMART‐IRB also has other tools to facilitate the sIRB review process) 35 . Klitzman et al 36 suggest consideration of the following areas: linguistic and cultural issues, geographic and socioeconomic issues, researcher‐specific issues, and institution‐specific issues.…”

Requiring a Single IRB for Cooperative Research in the Revised Common Rule: What Lessons Can Be Learned from the UK and Elsewhere?

“…Recent empirical research conducted in the US also suggests that the importance of local knowledge can be overstated (but not necessarily irrelevant). 18 However, other empirical research I recently conducted also suggests that homogeneity (and in turn, greater consistency) of practice — and by corollary, trust by stakeholders in the processes and outcomes of a given ethics committee — depends crucially on two inter-related factors: 1) from a more top-down perspective, a robust overarching regulatory structure with committed leadership that works to improve procedural consistency across all ethics committees participating in a mutual recognition system; and 2) from a more bottom-up perspective, a stake-holder-led initiative with committed buy-in to drive change in the regulatory approach. Both a top-down and bottom-up approach are needed to effect robust and sustained regulatory change in ethics review.…”