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Institutional Review Board Variability in Minimal-Risk Multicenter Urogynecology Studies.
MedLine Citation:
PMID:  22453318     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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.
Authors:
Heidi S Harvie; Lior Lowenstein; Tola B Omotosho; Tatiana Sanses; Stephanie Molden; Janet Hardy; Linda Brubaker;
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Publication Detail:
Type:  JOURNAL ARTICLE    
Journal Detail:
Title:  Female pelvic medicine & reconstructive surgery     Volume:  18     ISSN:  2151-8378     ISO Abbreviation:  -     Publication Date:  2012 Mar 
Date Detail:
Created Date:  2012-3-28     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101528690     Medline TA:  Female Pelvic Med Reconstr Surg     Country:  -    
Other Details:
Languages:  ENG     Pagination:  89-93     Citation Subset:  -    
Affiliation:
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.
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