Institutional review board variability in minimal-risk multicenter urogynecology studies

Heidi S. Harvie, University of Pennsylvania
Lior Lowenstein, Loyola University Medical Center
Tola B. Omotosho, Loyola University
Tatiana V. D. Sanses, University of Maryland Medical Center
Stephanie Molden, The Institute for Female Pelvic Medicine and Reconstructive Surgery
Janet R. Hardy, University of Massachusetts Medical School
Linda Brubaker, Loyola University

Document Type Article

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.