机构/区域临床试验伦理委员会建设与发展的探讨
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篇名: 机构/区域临床试验伦理委员会建设与发展的探讨
TITLE:
摘要: 目的:探索临床试验伦理委员会现阶段的运行模式,讨论其建设和发展方向。方法:通过分析机构伦理委员会与区域伦理委员会在审查效率、审查标准和质量、对项目具体实施情况的了解和利益冲突层面存在的优势与不足,提出两者建设与发展的方向和建议。结果与结论:通常情况下,机构伦理委员会对项目具体实施情况能够及时充分了解,但存在审查效率低、审查标准不一致、审查质量稍差和难以避免利益冲突的问题;区域伦理委员会则具有审查效率高、审查标准一致、审查质量相对较高以及可有效避免利益冲突的优势,但却对项目具体实施情况难以做到及时充分了解。目前两种伦理审查模式尚不可相互取代,应发挥各自的优势相互补充,两者相辅相成,共同发展。建议机构伦理委员会应在现有基础上不断改进和完善,以监督本机构临床试验的正常开展;而区域伦理委员会应对特殊临床试验开展伦理审查,并重在培训和指导本区域内伦理委员会的建设和发展。
ABSTRACT: OBJECTIVE: To explore the current operation model of the ethics committee of clinical trial, and discuss the direction of its construction and development. METHODS: The advantages and disadvantages of the institutional ethics committee and the regional ethics committee were analyzed through reviewing efficiency, reviewing standards and quality, investigating the implementation of projects and conflict of interest. The direction and suggestions were put forward for the construction and development of them. RESULTS & CONCLUSIONS: Usually, the institutional ethics committee could fully understand the specific implementation of the project, but there were some problems such as low efficiency, inconsistent review standard, low review quality  and hard to avoid the conflict of interest. In contrast, the regional ethics committee review had high efficiency, consistent review standard, high review quality and can avoid conflicts of interest effectively, but it was hard to fully grasp the project implementation. Actually, the two kinds of ethical review mode still can not replace each other, but should play their respective advantages to complement each other. The institutional ethics committee should be constantly improved and perfected so as to supervise the normal development of clinical trials. However, the regional ethics committee should pay attention to the ethical review of special clinical trials, and focus on the construction and development of ethical committees in the region.
期刊: 2018年第29卷第13期
作者: 温珠明,舒芳,金韵
AUTHORS: WEN Zhuming,SHU Fang,JIN Yun
关键字: 区域伦理委员会;机构伦理委员会;伦理审查;优势与不足;建设与发展
KEYWORDS: Regional ethics committee; Institutional ethics committee; Ethical review; Advantages and disadvantages; Construction and development
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