Institutional review board variability in minimal-risk multicenter urogynecology studies Journal Article

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Authors: Harvie, H. S.; Lowenstein, L.; Omotosho, T. B.; Sanses, T.; Molden, S.; Hardy, J.; Brubaker, L; Fellows' Pelvic Research Network
Article Title: Institutional review board variability in minimal-risk multicenter urogynecology studies
Abstract: 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.
Journal Title: Female Pelvic Medicine Reconstructive Surgery
Volume: 18
Issue: 2
ISSN: 2151-8378
Publisher: Unknown  
Journal Place: United States
Date Published: 2012
Start Page: 89
End Page: 92
Language: eng
DOI/URL:

10.1097/SPV.0b013e318249bd40

10.1097/SPV.0b013e318249bd40
Notes: JID: 101528690; ppublish