中国药房2012，Vol.23Issue(21)：1931-1933,3.DOI:10.6039/j.issn.1001-0408.2012.21.05
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
摘要
Abstract
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 recruitment, weak management mechanism and non-standardized informed consent implementation, etc. The level and quality of supervision 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Key words
Drug clinical trials/ Ethic committee/ Problems/ Strategies分类
医药卫生引用本文复制引用
姚战鹏,王婧雯,金鑫,贾艳艳,马忠英,彭莉,文爱东..我国药物临床试验中的伦理问题与对策[J].中国药房,2012,23(21):1931-1933,3.基金项目
国家"重大新药创制"科技重大专项资助项目(2011ZXJ09202-13) （2011ZXJ09202-13）
