药物临床试验中伦理审查存在的问题与对策

Problems and Strategies of Ethic Censorship in Clinical Trials

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。

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.