对我国药物临床研究受试者权益保护的法理学思考  

Jurisprudence Thinking on Rights and Interests Protection of Chinese Human Subjects of Drug Clinical Research

作　　者：邵蓉[1] 张玥[1] 魏巍[1] 

机构地区：[1]中国药科大学医药产业发展研究中心,南京211198

出　　处：《中国药事》2011年第11期1065-1067,1093,共4页Chinese Pharmaceutical Affairs

基　　金：江苏省教育厅高校哲学社会科学基金指导项目(编号2011SJD820004)

摘　　要：目的探讨药物临床研究受试者权益保护问题。方法分析药物临床研究受试者的弱势地位,并从法理学角度探讨保护药物临床研究受试者权益的必要性及理论基础。结果与结论我国GCP规定了受试者的诸多权利,体现了对受试者的倾斜性保护,这是实现实质平等的客观需要,也是保护其权益的有效方式,但仍存在瑕疵,应在修法中不断完善。Objective To discuss the problem of protecting human subjects of drug clinical research.Methods Analyzed the vulnerable position of human subjects of drug clinical research,and then discussed the necessity to protect their rights and interests and theory base from a jurisprudence perspective.Results and Conclusion GCP provided human subjects some rights,giving them protection measures.It was not only the objective needs for achieving substantive equality but also an effective way to protect their interests.But GCP had many defects which should be changed in the revision of legal.

关 键 词：药物 临床研究 受试者 GCP 

分 类 号：R95[医药卫生—药学]