从伦理审查批件看临床试验伦理委员会的组成及相关问题的探讨  

Discussion on the Composition of Clinical Trial Ethics Committee and Related Issues from the Approval of Ethical Review

作　　者：张长泽[1] 杜瑜[1] 王政[1] Zhang Changze;Du Yu;Wang Zheng(Drug Clinical Trial Institutions,Zhongshan Hospital Affiliated to Xiamen University,Xiamen 361004,China)

机构地区：[1]厦门大学附属中山医院药物临床试验机构,厦门361004

出　　处：《中国药事》2019年第3期241-245,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:对照现行法规要求,了解临床试验伦理委员会的人员组成和审查会议情况,发现存在问题并提出相关建议。方法:调查临床试验伦理批件,分析伦理委员会人员名单、会议签到表和审查决定。结果:伦理委员会的人员组成基本符合法规要求,审查会议出席情况有待改进。结论:伦理委员会审查水平日渐提高,人员组成有待优化,独立性有待加强,主管部门加强对伦理委员会的监管很有必要。Objective: To understand current composition of the Clinical Trial Ethics Committee and review conferences according to requirements of current laws and regulations in order to identify problems and put forward relevant suggestions. Methods: Approvals of ethical review for clinical trials were investigated. Members of the ethical committee, attendance checklists, and review decisions were analyzed. Results: The composition of the ethics committee basically met the requirements of laws and regulations. Attendance of the review conferences needed to be improved. Conclusion: The review level of the ethics committee is improving, the composition needs to be optimized, independence needs to be strengthened, and it is necessary for the department in charge to strengthen the supervision of the ethics committee.

关 键 词：伦理批件 临床试验 伦理委员会 人员组成 审查会议 

分 类 号：R95[医药卫生—药学]