药物临床研究受试者知情同意权法律保护之探析  

Discussion and analysis on legal protection of human subjects’ informed consent in 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：《上海医药》2011年第8期409-412,共4页Shanghai Medical & Pharmaceutical Journal

基　　金：江苏省教育厅高校哲学社会科学基金指导项目"药物临床试验受试者权益保障体系研究"(编号:2011SJD820004)

摘　　要：目的:为我国药物临床研究受试者知情同意权法律保护提供参考。方法:对药物临床研究受试者知情同意权法律保护的重要意义进行阐释,总结我国实现受试者知情同意权过程中存在的问题并对原因进行剖析;介绍受试者知情同意权立法现状,探究立法缺陷。结果与结论:建议通过加强对受试者及研究者的法制教育、构建完善的法律法规保障制度、健全伦理委员会监管机制等措施来完善受试者知情同意权的法律保护。Objective： To provide references for legal protection of human subjects’ informed consent in drug clinical research in China.Methods： We explained the significance of human subjects’ informed consent in drug clinical research,found some problems in the realization of human subjects’ informed consent and then analyzed the reasons.Besides,we introduced interrelated legislation and explored legislation defect.Results Conclusions： At present,we should improve legal protection of human subjects’ informed consent by strengthening legal education for both human subjects and researchers,building a sound regulation system,perfecting regulatory mechanism of Ethics Committee and so on.

关 键 词：临床研究 知情同意权 

分 类 号：R-051[医药卫生] D922.16[政治法律—宪法学与行政法学]