Variability in the costs of institutional review board oversight
Variability in the costs of institutional review board oversight
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DOI：
10.1097/00001888-200608000-00006
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发表时间：
2006-08-01
影响因子：
7.4
通讯作者：
Sugarman, Jeremy
中科院分区：
文献类型：
--
作者：
Byrne, Margaret M.;Speckman, Jeanne;Sugarman, Jeremy
背景 先前的研究表明，在机构审查委员会（IRB）研究监督成本方面，规模经济的机构之间存在巨大差异。在这项研究中，作者探讨了 IRB 成本的可变性，同时考虑到组织规模、监督成本的组成部分和协议类型。 方法 作者对学术医疗中心进行了一项调查，以收集 2002 年与 IRB 监督相关的资源利用信息。他们使用国家成本权重为所使用的每种资源类型分配成本，并对 IRB 成本的加权资源利用率进行求和。生成了总体成本、方案体积的三分位数、成本组成部分和审查类型的描述性统计数据。他们还确定了成本变化最大的地方。结果每个方案审查的 IRB 成本在整体和三分位数范围内变化很大。规模较大的机构成本较低，这表明了规模经济。然而，并非 IRB 成本的所有组成部分（例如董事会时间）都受到规模经济的影响。在小规模机构中，协议的快速审查并不便宜。结论 IRB 的监督成本变化很大，只有部分变化可能归因于规模经济。鉴于成本差异如此之大，作者得出的结论是，一些机构正在以低效或低质量的方式进行审查。未来的工作需要确定审查的具体做法，以及如何形成最佳质量和最有效的监督和审查系统。
Background Previous studies have shown wide differences between institutions in economies of scale with regard to the costs of institutional review board (IRB) oversight of research. in this study, the authors explored variability among IRB costs, taking into account organizational size, components of the costs of oversight, and protocol type.Method The authors conducted a survey of academic medical centers to collect information on resource utilization associated with IRB oversight in 2002. They used national cost weights to assign a cost to each type of resource used, and summed weighted resource utilization for IRB costs. Descriptive statistics were generated for costs over all, tertile of protocol volume, cost component, and type of review. They also determined where the greatest cost variability is found.Results IRB costs per protocol reviewed are highly variable both overall and within tertiles of volume. Higher-volume institutions have lower costs, which is indicative of economies of scale. However, not all components of IRB costs (e.g., board time) are subject to economies of scale. Expedited reviews of protocols are not less expensive at low-volume institutions.Conclusions IRB costs for oversight are highly variable, and only some of the variation may be attributable to economies of scale. Given such wide variation in costs, the authors conclude that some institutions are conducting reviews in a manner that is inefficient or of low quality. Future work is needed to determine specific practices in reviews, and what leads to the best quality and most efficient oversight and review system.