Browsing by Author "Chronic Hypertension and Pregnancy Consortium"

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    Outcomes of shared institutional review board compared with multiple individual site institutional review board models in a multisite clinical trial
    (Elsevier, 2023) Martin, Samantha L.; Allman, Phillip H.; Dugoff, Lorraine; Sibai, Baha; Lynch, Stephanie; Ferrara, Jennifer; Aagaard, Kjersti; Zornes, Christina; Wilson, Jennifer L.; Gibson, Marie; Adams, Molly; Longo, Sherri A.; Staples, Amy; Saade, George; Beche, Imene; Carter, Ebony B.; Owens, Michelle Y.; Simhan, Hyagriv; Frey, Heather A.; Khan, Shama; Palatnik, Anna; August, Phyllis; Irby, Les'Shon; Lee, Tiffany; Lee, Christine; Schum, Paula; Chan-Akeley, Rosalyn; Duhon, Catera; Rincon, Monica; Gibson, Kelly; Wiegand, Samantha; Eastham, Donna; Oparil, Suzanne; Szychowski, Jeff M.; Tita, Alan; Chronic Hypertension and Pregnancy Consortium; Obstetrics and Gynecology, School of Medicine
    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.