TY - JOUR
T1 - Institutional review board variability in minimal-risk multicenter urogynecology studies
AU - Harvie, Heidi S.
AU - Lowenstein, Lior
AU - Omotosho, Tola B.
AU - Sanses, Tatiana
AU - Molden, Stephanie
AU - Hardy, Janet
AU - Brubaker, Linda
PY - 2012
Y1 - 2012
N2 - 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.
AB - 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.
KW - Bioethics
KW - IRB variability
KW - Institutional review board
KW - Multicenter studies
KW - Research standards
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U2 - 10.1097/SPV.0b013e318249bd40
DO - 10.1097/SPV.0b013e318249bd40
M3 - Review article
C2 - 22453318
AN - SCOPUS:84860610253
SN - 2151-8378
VL - 18
SP - 89
EP - 93
JO - Female Pelvic Medicine and Reconstructive Surgery
JF - Female Pelvic Medicine and Reconstructive Surgery
IS - 2
ER -