Scherzinger Gregor, Bobbert Monika
a Institute of Social Ethics, University of Lucerne, Lucerne , Switzerland.
b Seminar of Moral Theology, University of Muenster , Muenster , Germany.
Account Res. 2017;24(3):152-176. doi: 10.1080/08989621.2016.1273778. Epub 2016 Dec 22.
Repeatedly, adequacy, performance and quality of Ethics Committees that oversee medical research trials are being discussed. Although they play a crucial role in reviewing medical research and protecting human subjects, it is far from clear to what degree they fulfill the task they have been assigned to. This eventuates in the call for an evaluation of their activity and, in some places, led to the establishment of accreditation schemes. At the same time, IRBs have become subject of detailed legislation in the process of the ongoing global juridification of medical research. Unsurprisingly, there is a tendency to understand the evaluation of RECs as a question of controlling their legal compliance. This paper discusses the need for a quality evaluation of IRBs from an ethical point of view and, by systematically reviewing the major ethical guidelines for IRBs, proposes a system of criteria that should orientate any evaluation of IRBs.
监督医学研究试验的伦理委员会的充分性、表现和质量问题被反复讨论。尽管它们在审查医学研究和保护人类受试者方面发挥着关键作用，但它们在多大程度上完成了分配给它们的任务却远不清楚。这导致了对其活动进行评估的呼声，在一些地方还引发了认证计划的建立。与此同时，在医学研究不断全球法治化的过程中，机构审查委员会（IRB）已成为详细立法的对象。不出所料，有一种将对伦理审查委员会（REC）的评估理解为控制其法律合规性问题的趋势。本文从伦理角度讨论了对IRB进行质量评估的必要性，并通过系统回顾IRB的主要伦理准则，提出了一个应指导对IRB进行任何评估的标准体系。
