TY - JOUR
T1 - Outcomes of shared institutional review board compared with multiple individual site institutional review board models in a multisite clinical trial
AU - Chronic Hypertension and Pregnancy Consortium
AU - Martin, Samantha L.
AU - Allman, Phillip H.
AU - Dugoff, Lorraine
AU - Sibai, Baha
AU - Lynch, Stephanie
AU - Ferrara, Jennifer
AU - Aagaard, Kjersti
AU - Zornes, Christina
AU - Wilson, Jennifer L.
AU - Gibson, Marie
AU - Adams, Molly
AU - Longo, Sherri A.
AU - Staples, Amy
AU - Saade, George
AU - Beche, Imene
AU - Carter, Ebony B.
AU - Owens, Michelle Y.
AU - Simhan, Hyagriv
AU - Frey, Heather A.
AU - Khan, Shama
AU - Palatnik, Anna
AU - August, Phyllis
AU - Irby, Les'Shon S.
AU - Lee, Tiffany
AU - Lee, Christine
AU - Schum, Paula
AU - Chan-Akeley, Rosalyn
AU - Duhon, Catera
AU - Rincon, Monica
AU - Gibson, Kelly
AU - Wiegand, Samantha
AU - Eastham, Donna
AU - Oparil, Suzanne
AU - Szychowski, Jeff M.
AU - Tita, Alan
N1 - Funding Information:
This work was supported by the National Institutes of Health (NIH; Chronic Hypertension and Pregnancy trial; grant number 5U01HL12338-05 ). S.L.M. was supported during work on this project with an NIH-funded T32 training award (grant number T32HL007457 ).
Funding Information:
The Chronic Hypertension and Pregnancy (CHAP) trial is a large multicenter research study funded by the National Heart, Lung, and Blood Institute in 2014. 16 The overall objective of the CHAP trial is to test the effectiveness and safety of antihypertensives for women with mild chronic hypertension (CHTN) during pregnancy. The current study investigated the IRB models used at CHAP trial sites; some sites opted to use their IRB model, whereas others chose a shared IRB model with 1 center serving as the centralized IRB hub. Our objective was to test for differences in IRB processing times and other characteristics, including stipulations (ie, editorial modifications, regulatory requests, verbiage and language modifications, and formatting) between site (individual) IRB and shared IRB models.
Publisher Copyright:
© 2023 Elsevier Inc.
PY - 2023/6
Y1 - 2023/6
N2 - BACKGROUND: Institutional review boards play a crucial role in initiating clinical trials. Although many multicenter clinical trials use an individual institutional review board model, where each institution uses their local institutional review board, it is unknown if a shared (single institutional review board) model would reduce the time required to approve a standard institutional review board protocol. OBJECTIVE: This study aimed to compare processing times and other processing characteristics between sites using a single institutional review board model and those using their individual site institutional review board model in a multicenter clinical trial. STUDY DESIGN: This was a retrospective study of sites in an open-label, multicenter randomized control trial from 2014 to 2021. Participating sites in the multicenter Chronic Hypertension and Pregnancy trial were asked to complete a survey collecting data describing their institutional review board approval process. RESULTS: A total of 45 sites participated in the survey (7 used a shared institutional review board model and 38 used their individual institutional review board model). Most sites (86%) using the shared institutional review board model did not require a full-board institutional review board meeting before protocol approval, compared with 1 site (3%) using the individual institutional review board model (P<.001). Median total approval times (41 vs 56 days; P=.42), numbers of submission rounds (1 vs 2; P=.09), and numbers of institutional review board stipulations (1 vs 4; P=.12) were lower for the group using the shared institutional review board model than those using the individual site institutional review board model; however, these differences were not statistically significant. CONCLUSION: The findings supported the hypothesis that the shared institutional review board model for multicenter studies may be more efficient in terms of cumulative time and effort required to obtain approval of an institutional review board protocol than the individual institutional review board model. Given that these data have important implications for multicenter clinical trials, future research should evaluate these findings using larger or multiple multicenter trials.
AB - BACKGROUND: Institutional review boards play a crucial role in initiating clinical trials. Although many multicenter clinical trials use an individual institutional review board model, where each institution uses their local institutional review board, it is unknown if a shared (single institutional review board) model would reduce the time required to approve a standard institutional review board protocol. OBJECTIVE: This study aimed to compare processing times and other processing characteristics between sites using a single institutional review board model and those using their individual site institutional review board model in a multicenter clinical trial. STUDY DESIGN: This was a retrospective study of sites in an open-label, multicenter randomized control trial from 2014 to 2021. Participating sites in the multicenter Chronic Hypertension and Pregnancy trial were asked to complete a survey collecting data describing their institutional review board approval process. RESULTS: A total of 45 sites participated in the survey (7 used a shared institutional review board model and 38 used their individual institutional review board model). Most sites (86%) using the shared institutional review board model did not require a full-board institutional review board meeting before protocol approval, compared with 1 site (3%) using the individual institutional review board model (P<.001). Median total approval times (41 vs 56 days; P=.42), numbers of submission rounds (1 vs 2; P=.09), and numbers of institutional review board stipulations (1 vs 4; P=.12) were lower for the group using the shared institutional review board model than those using the individual site institutional review board model; however, these differences were not statistically significant. CONCLUSION: The findings supported the hypothesis that the shared institutional review board model for multicenter studies may be more efficient in terms of cumulative time and effort required to obtain approval of an institutional review board protocol than the individual institutional review board model. Given that these data have important implications for multicenter clinical trials, future research should evaluate these findings using larger or multiple multicenter trials.
KW - Chronic Hypertension and Pregnancy trial
KW - federal regulations
KW - institutional review board efficiency
KW - institutional review boards
KW - multicenter studies
UR - http://www.scopus.com/inward/record.url?scp=85152785383&partnerID=8YFLogxK
U2 - 10.1016/j.ajogmf.2023.100861
DO - 10.1016/j.ajogmf.2023.100861
M3 - Article
C2 - 36669562
AN - SCOPUS:85152785383
SN - 2589-9333
VL - 5
JO - American Journal of Obstetrics and Gynecology MFM
JF - American Journal of Obstetrics and Gynecology MFM
IS - 6
M1 - 100861
ER -