Is Your Ethics Committee Efficient? Using "IRB Metrics'' as a Self-Assessment Tool for Continuous Improvement at the Faculty of Tropical Medicine, Mahidol University, Thailand
Is Your Ethics Committee Efficient? Using "IRB Metrics'' as a Self-Assessment Tool for Continuous Improvement at the Faculty of Tropical Medicine, Mahidol University, Thailand
复制标题
DOI：
10.1371/journal.pone.0113356
复制
发表时间：
2014-11-18
期刊：
影响因子：
3.7
通讯作者：
Khusmith, Srisin
中科院分区：
文献类型：
--
作者：
Adams, Pornpimon;Kaewkungwal, Jaranit;Khusmith, Srisin
据报道，一些机构的研究人员和伦理委员会之间关系紧张。一些报告表明，研究人员对机构审查委员会（IRB）审查的质量缺乏信心，如果研究人员认为委员会的担忧和批评不公正，那么强调严格的程序合规性和IRB提出的伦理问题可能会无意中导致研究人员和伦理委员会之间的通信延迟，甚至鼓励推诿/模棱两可。本研究系统地分析了内部评级机构不同职能的效率，以及效率与决策过程感知质量的关系。因此，本研究的主要目的是（1）使用泰国玛希隆大学热带医学系（FTM-EC）开发的IRB伦理委员会评估其伦理委员会的运营效率和感知有效性，以及（2）确定可能导致批准过程持续时间超过60天目标限值的伦理问题。基于文献综述的定义和方法，使用和建议使用，在评估IRB质量的各个方面，一个“IRB度量”的开发，以评估IRB过程中使用的结构-过程-结果测量模型。为了观察评价指标的趋势，提取并分析了2010年1月至2013年9月期间提交给FTM-EC两个小组（临床和非临床）的所有方案相关数据。基于内部评级结构-过程-结果的定量信息阐明了内部过程改进的不同领域。IRB向研究者提出的伦理问题（与方案审查中的批准过程持续时间相关）可被视为双方关系紧张的根本原因。因此，对IRB结构-过程-结果的评估提供了一个宝贵的机会，可以加强IRB和研究人员之间的关系，减少冲突，为参与人类受试者研究的所有各方带来积极的结果。
Tensions between researchers and ethics committees have been reported in several institutions. Some reports suggest researchers lack confidence in the quality of institutional review board (IRB) reviews, and that emphasis on strict procedural compliance and ethical issues raised by the IRB might unintentionally lead to delays in correspondence between researchers and ethics committees, and/or even encourage prevarication/equivocation, if researchers perceive committee concerns and criticisms unjust. This study systematically analyzed the efficiency of different IRB functions, and the relationship between efficiency and perceived quality of the decision-making process. The major purposes of this study were thus (1) to use the IRB Metrics developed by the Faculty of Tropical Medicine, Mahidol University, Thailand (FTM-EC) to assess the operational efficiency and perceived effectiveness of its ethics committees, and (2) to determine ethical issues that may cause the duration of approval process to be above the target limit of 60 days. Based on a literature review of definitions and methods used and proposed for use, in assessing aspects of IRB quality, an "IRB Metrics'' was developed to assess IRB processes using a structure-process-outcome measurement model. To observe trends in the indicators evaluated, data related to all protocols submitted to the two panels of the FTM-EC (clinical and non-clinical), between January 2010-September 2013, were extracted and analyzed. Quantitative information based on IRB Metrics structure-process-outcome illuminates different areas for internal-process improvement. Ethical issues raised with researchers by the IRB, which were associated with the duration of the approval process in protocol review, could be considered root causes of tensions between the parties. The assessment of IRB structure-process-outcome thus provides a valuable opportunity to strengthen relationships and reduce conflicts between IRBs and researchers, with positive outcomes for all parties involved in the conduct of human-subject research.