从伦理委员会视角论中英药物临床研究受试者保护的比较  

A Comparative Study on the Protection of Human Subjects of Drug Clinical Research Between UK and China——the Perspective of Ethics Committee

作　　者：邵蓉[1] 张玥[1] 王宗敏 郑澜[1] 魏巍[1] 

机构地区：[1]中国药科大学医药产业发展研究中心,南京211198 [2]江苏省食品药品监督管理局

出　　处：《中国药事》2012年第9期931-935,共5页Chinese Pharmaceutical Affairs

基　　金：江苏省教育厅2011年度高校哲学社会科学研究指导项目(编号2011SJD820004)

摘　　要：目的从伦理委员会角度为我国药物临床研究受试者保护建言献策。方法阐述伦理委员会对受试者保护的重要意义,对中英药物临床研究伦理委员会的法律法规、人员组成、监督管理等方面进行比较分析。结果与结论与英国相比,我国伦理委员会在立法、规范内容、组织运行、监督管理等方面均存在一些问题。从完善受试者权益保护立法、保障伦理委员会的独立性、建立有效的伦理委员会监管机制等角度提出了对策与建议。Objective To give advice on protecting subjects of drug clinical trials in China by the perspective study on ethics committees. Methods The significance of ethics committees to protect subjects was elucidated, and ethics committees in China and the U.K. were compared in aspects such as regulations, members and supervision. Results and Conclusion Compared with those in the U. K. , ethics committees in China are still facing problems in regulations, operation and supervision, which pose threats to protecting the rights of clinical trial subjects. In this view, approaches and suggestions were proposed to promote the construction of ethics committees in China such as improving legislation for protection of subjects＇ rights, guaranteeing the independence of ethics committees, establishing an effective supervision system, etc.

关 键 词：药物 临床研究 伦理委员会 药品临床试验管理规范 

分 类 号：R954.73[医药卫生—药学]