Outcomes of Shared IRB Compared with Multiple Individual Site IRB Models in a Multisite Clinical Trial.

Overview

abstract

BACKGROUND: Institutional review boards play a crucial role in initiating clinical trials. Though many multicenter clinical trials utilize an individual IRB model, where each institution uses their own local IRB, it is unknown if a shared (single IRB) model would reduce the time required to approve a standard IRB protocol. OBJECTIVE: The objective of this study was to compare processing times and other processing characteristics between sites using a single IRB and those using their own site IRBs in a multicenter clinical trial. STUDY DESIGN: This was a retrospective study of sites in an open-label, multicenter randomized control trial from 2014-2021. Participating sites in the multicenter Chronic Hypertension and Pregnancy (CHAP) trial were asked to complete a survey collecting data describing their IRB approval process. RESULTS: Forty-five sites participated in the survey (7 used a shared IRB and 38 used their own individual IRBs). Most sites (86%) using the shared IRB model did not require a full board IRB meeting prior to protocol approval, compared to one site (3%) within the individual IRB group (p < 0.001). Median total approval times (41 vs. 56 days; p = 0.42), numbers of submission rounds (1 vs. 2, p=0.09), and numbers of IRB stipulations (1 vs. 4; p=0.12) were lower for the shared than individual site IRB model, but these differences were not statistically significant. CONCLUSION: Our findings support the hypothesis that the shared IRB model for multicenter studies may be more efficient in terms of cumulative time and effort required to obtain approval of an IRB protocol. Given that these data have important implications for multicenter clinical trials, future research should evaluate these findings using larger or multiple multicenter trials.