Institutional review board variability in minimal-risk multicenter urogynecology studies
Department of Medicine, Division of Preventive and Behavioral Medicine
Academies and Institutes; Clinical Protocols; Consent Forms; Ethics Committees, Research; Guideline Adherence; *Gynecology; Humans; Multicenter Studies as Topic; *Research Design; Risk Adjustment; *Urology
Life Sciences | Medicine and Health Sciences | Women's Studies
OBJECTIVES: To investigate variability among local institutional review boards (IRBs) in the review process of standardized multicenter urogynecologic studies with common protocols.
METHODS: Descriptive study of the IRB review and approval process for common urogynecologic protocols of 4 minimal-risk multicenter studies conducted within the Fellow's Pelvic Research Network (FPRN), including prospective cohort, retrospective review, and case-control studies.
RESULTS: Most of the 22 network sites (73%) were in academic institutions. The level of IRB review varied by site and study design. Institutional review boards had local requirements regarding standard format and language that resulted in 86% of consent documents and 33% of protocols being changed before submission. Institutional review boards queried most (55%) submissions, with significantly more queries for prospective studies compared to retrospective studies (78.6% vs 35.3%; P = 0.03). After submission, IRB requirements necessitated changes for 71% of consents and 28% of protocols. There were no substantive changes made to any consent document or protocol. There was considerable variability in time between IRB submission and approval (10 +/- 3 days; range, 7-12 days for exempt; 22 +/- 17 days; range, 1-57 days for expedited; and 34 +/- 32 days; range, 13-81 days for full board reviews).
CONCLUSIONS: We detected considerable variability in IRB review of standardized multicenter protocols across minimal-risk study designs. Reduction in variability may improve expediency of multicenter studies while maintaining the highest level of protections for research participants.
DOI of Published Version
Female Pelvic Med Reconstr Surg. 2012 Mar-Apr;18(2):89-92. Link to article on publisher's site
Female pelvic medicine and reconstructive surgery
Harvie, Heidi S.; Lowenstein, Lior; Omotosho, Tola B.; Sanses, Tatiana V. D.; Molden, Stephanie; Hardy, Janet R.; and Brubaker, Linda, "Institutional review board variability in minimal-risk multicenter urogynecology studies" (2012). Women’s Health Research Faculty Publications. 523.