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.
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Citation: Female Pelvic Med Reconstr Surg. 2012 Mar-Apr;18(2):89-92. Link to article on publisher's site