建设临床试验区域性伦理审查机制的设想——以广东地区为例  

Construction of Regional Ethical Review Mechanism of Clinical Trial: Taking Guangdong Area as an Example

作　　者：刘瑜[1,2,3] 张念樵[1] 钟筱华 黎欣盈 胡兴媛[3,4] 向媛薇 LIU Yu;ZHANG Nianqiao;ZHONG Xiaohua;LI Xinying;HU Xingyuan;XIANG Yuanwei(Ethics Committee, the First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510405, China;Guangzhou University of Chinese Medicine, Guangzhou 510006, China;Regional Ethics Committee, Guangdong Pharmaceutical Association,Guangzhou 510080;Nanfang Hospital,Southern Medical University, Guangzhou 510515, China)

机构地区：[1]广州中医药大学第一附属医院伦理委员会 [2]广州中医药大学,广东广州510006 [3]广东省药学会区域伦理委员会,广东广州510080 [4]南方医科大学南方医院,广东广州510515

出　　处：《中国医学伦理学》2018年第10期1273-1280,共8页Chinese Medical Ethics

摘　　要：由于广东地区各医疗机构伦理审查能力参差不齐,审查模式效率不高,临床试验开展周期较长,医药企业研发时间及经济成本受到一定影响。为解决上述问题,根据广东地区医药产业特点、伦理审查总体水平以及临床试验情况,提出建设包括区域性伦理审查平台和成立区域伦理委员会的新伦理审查机制作为广东转化医学的基础设施,在提升临床试验伦理审查质量和效率的同时,提高广东地区科研伦理整体水平,切实保护受试者的权益,加快促进新药和医疗器械的研发;同时,介绍新成立的广东省药学会区域伦理委员会,以期通过实践实现上述目标。Due to the uneven ethical review abilities of various medical institutions in Guangdong, the inefficiency of the review mode and the longer development period of the clinical trials, the research and development time and economic costs of pharmaceutical companies are affected. In order to solve the above problems, according to the characteristics of the pharmaceutical industry in Guangdong, the overall level of ethical review and clinical trials, this paper proposed to build a new ethical review mechanism including regional ethical review platform and the establishment of regional ethics committee as the infrastructure of Guangdong translational medicine; while improving the quality and efficiency of ethical review of clinical trials, to improve the overall level of scientific research ethics in Guangdong, protect the rights and interests of the subjects and promote the research and development of new drug and medical device. At the same time, this paper introduced the newly established regional ethics committee of Guangdong Pharmaceutical Association, with a view to achieving the above objectives through practice.

关 键 词：临床试验 伦理审查 伦理审查质量 伦理审查机制 

分 类 号：R-052[医药卫生]