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Institutional Review Board Variability in Minimal-Risk Multicenter Urogynecology Studies

Harvie, Heidi S. MD, MBA, MSCE*; Lowenstein, Lior MD, MS; Omotosho, Tola B. MD; Sanses, Tatiana MD§; Molden, Stephanie MD; Hardy, Janet PhD, MSc, MPH; Brubaker, Linda MD, MS‡‡and for the Fellows’ Pelvic Research Network

Female Pelvic Medicine & Reconstructive Surgery: March/April 2012 - Volume 18 - Issue 2 - p 89–93
doi: 10.1097/SPV.0b013e318249bd40
Original Articles
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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.

There is considerable variability in institutional review boards’ 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 protection for research participants.

From the *Department of Obstetrics and Gynecology, University of Pennsylvania,Philadelphia, PA; †Department of Obstetrics and Gynecology, Rambam Medical Center Health Care Campus, Haifa, Israel; ‡Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque, NM; §Department of Obstetrics and Gynecology, GBMC/ University of Maryland Center, Baltimore, MD; ∥Department of Obstetrics and Gynecology, The Institute for Female Pelvic Medicine, Allentown, PA; ¶Department of Medicine, University of Massachusetts Medical School, Worcester, MA; and ‡Department of Obstetrics and Gynecology, Stritch School of Medicine, Loyola University, Chicago, IL.

Correspondence: Heidi Harvie, MD, MBA, MSCE, Urogynecology and Reconstructive Pelvic Surgery, 8815 Germantown Ave, Suite 46, Philadelphia, PA 19118. E-mail: hharvie@obgyn.upenn.edu.

Financial support for this project was provided by the Society of Gynecologic Surgeon’s Fellows Pelvic Research Network.

The authors declare that they have nothing to disclose.

© 2012 by Wolters Kluwer Health | Lippincott Williams & Wilkins