Variation in institutional review board responses to a standard protocol for a multicenter randomized, controlled surgical trial.
Variation in institutional review board responses to a standard protocol for a multicenter randomized, controlled surgical trial.
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DOI：
10.1016/j.juro.2009.02.032
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发表时间：
2009-06
期刊：
影响因子：
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通讯作者：
MIST Investigators
中科院分区：
文献类型：
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作者：
Helfand BT;Mongiu AK;Roehrborn CG;Donnell RF;Bruskewitz R;Kaplan SA;Kusek JW;Coombs L;McVary KT;MIST Investigators
机构审查委员会(IRBs)的主要责任是保护人类研究对象，从而确保研究按照一套标准的伦理原则进行。许多研究已经在涉及医疗疗法的多中心临床试验中比较了IRBs的反应。到目前为止，还没有人在调查手术干预的试验中进行过。这项研究的目的是调查良性前列腺增生症(BPH)微创手术疗法(MIST)中一家机构IRB向另一家机构发出的建议的一致性，这是一项具有统一同意和研究方案的多中心试验。在MIST研究方案首次提交后，我们从7个参与机构中的6个获得了IRB的答复，并对这些答复进行了分类。然后，我们将批准的方案重新分发给另一家参与机构的IRB，并分析了他们对这些方案的审查。我们发现，IRB批准相同的研究方案所需的回复数量和类型在参与机构之间都有很大差异。我们还发现，在第二次审查中，IRB的反应是不一致的，尽管所有方案最终都得到了批准。我们的结论是，在多中心手术试验的背景下，目前的局部IRB审查系统在审查过程中效率低下，可能无法提供监督手术试验的专业知识。基于这些结果，可能需要一个中心外科IRB来改进多中心试验中的伦理审查过程。
The primary responsibility of Institutional Review Boards (IRBs) is to protect human research subjects and therefore ensure that studies are conducted in accordance with a standard set of ethical principles. A number of studies have compared the responses from IRBs in multicenter clinical trials involving medical therapies. To date, none have been conducted in trials investigating surgical interventions. The intent of this study was to investigate the consistency of the recommendations issued from one institutional IRB to another in the Minimally Invasive Surgical Therapies (MIST) for benign prostatic hyperplasia (BPH), a multicenter trial with a uniform consent and study protocol. We obtained the IRB responses from six of the seven participating institutions after the initial submission of the MIST study protocol and classified the responses. We then re-distributed the approved protocols to an IRB at another participating institution and analyzed their review of these protocols. We found that both the number and types of responses required for IRB approval of an identical study protocol varied significantly among the participating institutions. We also found that IRB responses were inconsistent in the second review, although all protocols were ultimately approved. We conclude that the current system of local IRB review in the context of a multicenter surgical trial is inefficient in the review process and may not provide expertise in overseeing surgical trials. Based on these results, a central surgical IRB may be needed to improve of the ethical review process in multicenter trials.