Adams Pornpimon, Kaewkungwal Jaranit, Limphattharacharoen Chanthima, Prakobtham Sukanya, Pengsaa Krisana, Khusmith Srisin
Office of Research Services, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
Department of Tropical Hygiene, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
PLoS One. 2014 Nov 18;9(11):e113356. doi: 10.1371/journal.pone.0113356. eCollection 2014.
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.
据报道，在一些机构中研究人员与伦理委员会之间存在紧张关系。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，并且如果研究人员认为委员会的担忧和批评不合理，那么强调严格的程序合规性以及IRB提出的伦理问题可能会无意中导致研究人员与伦理委员会之间的沟通延迟，甚至会助长推诿/含糊其辞。本研究系统地分析了不同IRB职能的效率，以及效率与决策过程中感知质量之间的关系。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院（FTM-EC）开发的IRB指标来评估其伦理委员会的运作效率和感知有效性；（2）确定可能导致审批过程持续时间超过60天目标限制的伦理问题。基于对用于评估IRB质量的定义和方法的文献综述，开发了一种“IRB指标”，以使用结构-过程-结果测量模型来评估IRB流程。为了观察所评估指标的趋势，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IRB指标结构-过程-结果的定量信息揭示了内部流程改进的不同领域。IRB向研究人员提出的与方案审查中审批过程持续时间相关的伦理问题，可被视为双方之间紧张关系的根本原因。因此，对IRB结构-过程-结果的评估为加强IRB与研究人员之间的关系和减少冲突提供了宝贵机会，对参与人体研究的所有各方都有积极影响。
