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.
Keywords
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Article info
Publication history
Accepted:
January 4,
2023
Received in revised form:
December 19,
2022
Received:
July 27,
2022
Publication stage
In Press Accepted ManuscriptIdentification
Copyright
© 2023 Elsevier Inc. All rights reserved.
