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药物临床试验中伦理审查存在的问题与对策
引用本文:王荣梅.药物临床试验中伦理审查存在的问题与对策[J].中国医学伦理学,2007,20(1):35-36.
作者姓名:王荣梅
作者单位:山东大学第二医院,山东,济南,250033
摘    要:对我国目前药物临床试验伦理审查存在的问题进行了分析,并提出通过建立完善的伦理审查程序和审查标准,加强伦理委员会成员的培训,加大国际间的交流及监管力度等措施,提高伦理审查的质量和水平,以保障受试者的合法权益和临床研究的科学性和可靠性。

关 键 词:药物临床试验  伦理审查  受试者
文章编号:1001-8565(2007)01-0035-02
收稿时间:2006-12-25
修稿时间:2006-12-25

Problems and Strategies of Ethic Censorship in Clinical Trials
Wang Rongmei.Problems and Strategies of Ethic Censorship in Clinical Trials[J].Chinese Medical Ethics,2007,20(1):35-36.
Authors:Wang Rongmei
Institution:The Second Hospital of Shandong University, Shandong , Jinan , 250033
Abstract:To make the pharmaceutical clinical trials meet the ethic standard in our country,we make an analysis of the problems of current ethics censorship in this field.Moreover,we claim that for the purpose of scientific and reliable clinical research,the legal rights of subjects and the quality increase of ethics censorship,it is necessary to establish complete ethics censorship procedure and standard,intensify the training of the ethics committee's members,set up supervisory system and promote international community.
Keywords:pharmaceutical clinical trial  ethic censorship  subject
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