Perspectives of Researchers and Research Team Members Regarding Their Experience with sIRBs

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Our study examines the perspectives of researchers and other research team members who conducted National Institutes of Health (NIH)-funded studies about their use of a single institutional review board (sIRB) review and onboarding process. More than 84% (n = 639) of respondents agreed that NIH-sponsored multisite clinical trials benefit from sIRB use. A higher proportion of super-users (>10 studies) of an sIRB than moderate users (1-10 studies) described the onboarding process positively (n = 119, 56% vs. n = 225, 42%, p = .01) and found sIRBs to be more cost-effective than a site-specific model (n = 113, 53.05% vs. n = 221, 41%, p <.01). Timeline delays were experienced by over 90% (n = 680) of respondents and an increased administrative burden was reported by almost half (n = 353, 47%) of respondents. Respondents described increased administrative burden for sIRB approvals when an institution-specific application was required (n = 299, 51% vs. n = 30, 29%, p <.01). Most researchers judged sIRBs to be beneficial. However, delays in approval, increased administrative burden, and associated compulsory institution-specific applications posed logistical challenges for researchers. Reform efforts must focus on aligning sIRB and local study site standards to optimize sIRB study review.