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

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.