Costs and Benefits of the National Cancer Institute Central Institutional Review Board
Costs and Benefits of the National Cancer Institute Central Institutional Review Board
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DOI：
10.1200/jco.2009.23.2470
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发表时间：
2010-02-01
影响因子：
45.3
通讯作者：
Abrams, Jeffrey
中科院分区：
文献类型：
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作者：
Wagner, Todd H.;Murray, Christine;Abrams, Jeffrey
2001年，美国国家癌症研究所（NCI）成立了中央机构审查委员会（CIRB），对其多地点III期肿瘤试验进行单个人体受试者审查。本研究的目的是评估NCI的CIRB是否与处理成人III期肿瘤试验的更低努力、时间和成本相关。方法：我们进行了一项观察性研究，将NCI CIRB附属网站与使用当地IRB进行审查的非NCI CIRB附属网站进行了比较。对肿瘤学研究人员和IRB工作人员进行了调查，以了解工作量和时间安排。有效率分别为60%和42%。对这些调查数据的分析产生了有关工作量、时间和成本的信息。我们将这些数据与CIRB运营数据相结合，从社会角度确定CIRB的净储蓄。结果：加入scib与更快的审查（平均快了33.9个日历天）和6.1小时的研究人员工作有关。隶属CIRB与每次初步审查节省717美元有关。中心每月的费用估计为十六万一千元。从社会角度来看，CIRB每月的净成本约为55,000美元。由于没有审查质量的标准定义，因此没有评估CIRB是否导致更高或更低质量的审查。CIRB与研究者和IRB工作人员努力的减少和更快的方案审查有关，尽管如果机构按预期使用CIRB会节省更多的费用。
PurposeIn 2001, the National Cancer Institute (NCI) formed the Central Institutional Review Board (CIRB) to conduct a single human subjects review for its multisite phase III oncology trials. The goal of this study was to assess whether NCI's CIRB was associated with lower effort, time, and cost in processing adult phase III oncology trials.MethodsWe conducted an observational study and compared sites affiliated with the NCI CIRB to unaffiliated sites that used their local IRB for review. Oncology research staff and IRB staff were surveyed to understand effort and timing. Response rates were 60% and 42%, respectively. Analysis of these survey data yielded information on effort, timing, and costs. We combined these data with CIRB operational data to determine the net savings of the CIRB using a societal perspective.ResultsCIRB affiliation was associated with faster reviews (33.9 calendar days faster on average), and 6.1 fewer hours of research staff effort. CIRB affiliation was associated with a savings of $717 per initial review. The estimated cost of running the CIRB was $161,000 per month. The CIRB yielded a net cost of approximately $55,000 per month from a societal perspective. Whether the CIRB results in higher or lower quality reviews was not assessed because there is no standard definition of review quality.ConclusionThe CIRB was associated with decreases in investigator and IRB staff effort and faster protocol reviews, although savings would be higher if institutions used the CIRB as intended.