Helfand Brian T, Mongiu Anne K, Roehrborn Claus G, Donnell Robert F, Bruskewitz Reginald, Kaplan Steven A, Kusek John W, Coombs Laura, McVary Kevin T
Department of Urology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois 60611, USA.
J Urol. 2009 Jun;181(6):2674-9. doi: 10.1016/j.juro.2009.02.032. Epub 2009 Apr 16.
The primary responsibility of institutional review boards is to protect human research subjects and, therefore, ensure that studies are performed in accordance with a standard set of ethical principles. A number of groups have compared the responses of institutional review boards in multicenter clinical trials involving medical therapies. To our knowledge no such studies have been performed to date of trials investigating surgical intervention. We investigated the consistency of the recommendations issued by various institutional review boards in the Minimally Invasive Surgical Therapies study for benign prostatic hyperplasia, a multicenter trial with a uniform consent and study protocol.
We obtained the institutional review board response from 6 of the 7 participating institutions after initial submission of the Minimally Invasive Surgical Therapies study protocol and classified the responses. We then redistributed the approved protocols to an institutional review board at another participating institution and analyzed that review of these protocols.
We found that the number and type of responses required for institutional review board approval of an identical study protocol varied significantly among participating institutions. We also found that institutional review board responses were inconsistent in the second review, although all protocols were ultimately approved.
The current system of local institutional review board review in the context of a multicenter surgical trial is inefficient in the review process and may not provide expertise for overseeing surgical trials. Based on these results a central surgical institutional review board may be needed to improve the ethical review process in multicenter trials.
机构审查委员会的主要职责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。一些团体比较了机构审查委员会在涉及医学治疗的多中心临床试验中的反应。据我们所知，迄今为止尚未对研究手术干预的试验进行此类研究。我们调查了在一项针对良性前列腺增生的微创外科治疗研究中，各个机构审查委员会所发布建议的一致性，该研究是一项具有统一同意书和研究方案的多中心试验。
在最初提交微创外科治疗研究方案后，我们从7个参与机构中的6个获取了机构审查委员会的回复并进行分类。然后，我们将已批准的方案重新分发给另一个参与机构的机构审查委员会，并分析该委员会对这些方案的审查情况。
我们发现，对于同一研究方案，各参与机构在机构审查委员会批准所需的回复数量和类型上存在显著差异。我们还发现，尽管所有方案最终都获得了批准，但在第二次审查中，机构审查委员会的回复并不一致。
在多中心外科试验背景下，当前地方机构审查委员会的审查体系在审查过程中效率低下，可能无法为监督外科试验提供专业知识。基于这些结果，可能需要一个中央外科机构审查委员会来改善多中心试验中的伦理审查过程。
