Harvie Heidi S, Lowenstein Lior, Omotosho Tola B, Sanses Tatiana, Molden Stephanie, Hardy Janet, Brubaker Linda
Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA, USA.
Female Pelvic Med Reconstr Surg. 2012 Mar-Apr;18(2):89-92. doi: 10.1097/SPV.0b013e318249bd40.
To investigate variability among local institutional review boards (IRBs) in the review process of standardized multicenter urogynecologic studies with common protocols.
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.
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).
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.
调查当地机构审查委员会（IRB）在对采用通用方案的标准化多中心泌尿妇科研究进行审查过程中的变异性。
对在研究员盆腔研究网络（FPRN）内开展的4项最低风险多中心研究的通用泌尿妇科方案的IRB审查和批准过程进行描述性研究，包括前瞻性队列研究、回顾性审查和病例对照研究。
22个网络站点中的大多数（73%）位于学术机构。IRB审查水平因站点和研究设计而异。机构审查委员会对标准格式和语言有当地要求，导致86%的知情同意书和33%的方案在提交前被修改。机构审查委员会对大多数（55%）的提交材料进行了询问，前瞻性研究的询问明显多于回顾性研究（78.6%对35.3%；P = 0.03）。提交后，IRB的要求使得71%的知情同意书和28%的方案需要修改。对任何知情同意书或方案均未进行实质性修改。IRB提交与批准之间的时间存在很大差异（10±3天；范围，豁免审查为7 - 12天；快速审查为22±17天；范围，1 - 57天；全面委员会审查为34±32天；范围，13 - 81天）。
我们发现在最低风险研究设计中，IRB对标准化多中心方案的审查存在很大变异性。减少变异性可能会提高多中心研究的效率，同时保持对研究参与者的最高保护水平。
