Variation in local institutional review board evaluations of a multicenter patient safety study.
Variation in local institutional review board evaluations of a multicenter patient safety study.
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当地机构审查委员会对多中心患者安全研究的评估存在差异。
DOI：
10.1111/j.1945-1474.2011.00150.x
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发表时间：
2012
期刊：
影响因子：
--
通讯作者：
Pronovost,PeterJ
中科院分区：
文献类型：
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作者：
Thompson,DavidA;Kass,Nancy;Holzmueller,Christine;Marsteller,JillA;Martinez,ElizabethA;Gurses,AyseP;Kanchuger,Marc;Schwann,Nanette;Gibson,CharlesS;Bauer,Laura;Pronovost,PeterJ
几个非常明显的质量改进(QI)项目导致了对其道德监督的争议，引起了机构审查委员会(IRBs)和人类研究保护办公室(Office For Human Research Protection)的注意。虽然QI研究大幅增加，但关于多个IRBs如何审查同一研究的经验证据有限。这篇文章描述了同一项多中心QI研究中局部IRB评价的变化。这项名为“通过网络监控定位错误”的研究使用了多种数据收集方法来识别心血管手术室服务中的患者安全风险。这项研究包括研究小组对5家医院进行了为期2天的实地访问，以观察心脏手术程序并就临床实践和危险采访工作人员。调查是自行进行的。IRB程序在5家医院之间差别很大。审查范围从要求患者和手术室工作人员口头同意的全面委员会审查和批准，到确定研究豁免审查和参与者同意的IRB。IRB获得批准的时间从6周到6个月不等。这一变化表明，对指导IRBs的联邦法规有广泛的解释。采用统一性不仅会减少效率低下的情况，而且还会削弱目前IRB审查程序的随意性，因为这种程序往往不适当地影响假设的产生和研究设计。
Several highly visible quality improvement (QI) projects led to controversy over their ethical oversight, attracting attention from institutional review boards (IRBs) and the Office for Human Research Protection. While QI research has increased dramatically, there is limited empirical evidence regarding how multiple IRBs review the same study. This paper describes the variations in local IRB reviews for the same a multicenter QI study. The study, entitled “Locating Errors through Networked Surveillance”, used multiple data collection methods to identify patient safety risks in cardiovascular operating room services. This study involved 2‐day site visits to 5 hospitals by the research team to observe cardiac surgery procedures and interview staff regarding clinical practice and hazards. Surveys were self‐administered. The IRB process varied widely across the 5 hospitals. Reviews ranged from full committee review and approval with verbal consent required from patients and operating room staff, to an IRB determining the study exempt from review and participant consent. The time to IRB approval ranged from 6 weeks to 6 months. This variation suggests there is wide interpretation of the Federal regulations put in place to guide IRBs. The adoption of uniformity would not only reduce inefficiencies but also attenuate the perceived arbitrary nature of current IRB review processes that often inappropriately influence hypothesis‐generation and study design.