摘要
从广东省区域伦理委员会的建立历程,探讨区域伦理委员筹建、委员资质要求和选取、审查分组考量、工作开展以及未来规划等问题,发现区域伦理委员会的试点也遇到很多困难,如缺少专职人员、区域伦理委员会的职责尚无清晰划分等。通过对存在问题的分析,建议区域伦理委员会的组建单位应提供相应的成本支持,以保证区域伦理委员会的正常运行,规定审查的范围与职责,建立相关的制度、标准操作规程,申请国际、国内的相关伦理认证,最后在审查能力方面应达到一定的标准,提高公信力。
The authors discussed the establishment of Guangdong Regional Ethics Committee,including the criteria for selection of candidates for membership,consideration of conducting review by sub-committees,working procedure and future plans.There are several issues needed to be addressed during the establishment of regional ethics committee,such as lack of full-time staff,and unclear responsibilities of the regional ethics committee.Therefore,the authors analyzed the current problems of regional ethics committee and proposed several suggestions,including providing financial support for regional ethics committee to ensure the daily operation,clarifying the scope and responsibilities of regional ethics committee,establishing relevant regulations and standard operating procedures,setting up standards through international and domestic accreditations so as to enhance the credibility of the regional ethics committees.
出处
《医学与哲学（A）》
2018年第12期15-18,共4页
Medicine & Philosophy:Humanistic & Social Medicine Edition
基金
2017年广东省食品药品监督管理局科技创新项目(2018TDZ20)
关键词
区域伦理委员会
伦理审查
制度建设
regional ethics committee
ethical review
system construction
