我国药物临床试验中的伦理问题与对策  

Ethic Problems and Strategies for Drug Clinical Trials in China

作　　者：姚战鹏 王婧雯 金鑫 贾艳艳 马忠英 彭莉 文爱东 

机构地区：[1]第四军医大学第一附属医院科研科,西安710032 [2]第四军医大学第一附属医院药剂科,西安710032

出　　处：《中国药房》2012年第21期1931-1933,共3页China Pharmacy

基　　金：国家"重大新药创制"科技重大专项资助项目(2011ZXJ09202-13)

摘　　要：目的:了解目前我国药物临床试验机构伦理委员会表现的主要问题,为我国药物临床试验的开展和完善提供参考。方法:总结目前我国药物临床试验机构伦理委员会主要问题的表现形式,并分析原因,提出解决策略和方法。结果与结论:存在问题主要包括部分伦理委员会功能形式化、伦理委员会委员招募不规范、伦理委员会监督管理机制薄弱及知情同意执行不规范等。可通过建立完善的伦理内部监察体系、加强伦理委员会成员的素质培养以及建立电子信息化伦理监管平台等,提高伦理委员会的监管水平和质量,真正使临床试验符合科学真实性与伦理道德。OBJECTIVE： To explore the main problems of ethics committee of drug clinical trials institutions in China and to provide reference for the development and improvement of clinical trials in China. METHODS ： The patterns of main problems in ethics committee of drug clinical trials institutions in China were summarized and analyzed to put forward strateties and methods. RESULTS ＆ CONCLUSIONS： Main problems manifested as function formalization of ethics committee, non-standardized recruit- ment, weak management mechanism and non-standardized informed consent implementation, etc. The level and quality of supervi- sion of ethics committee could be improved by establishing inner supervision system, strengthening training of committee members＇ quality and establishing electronic information ethic supervision platform so as to achieve authenticity of science and ethics.

关 键 词：药物临床试验 伦理委员会 问题 对策 

分 类 号：R95[医药卫生—药学]