医学临床试验受试者权益保护的理论逻辑和现实路径  

The Theoretical Basis and Realistic Route of Subjects' Rights and Interests Protection in Medical Clinical Trials

作　　者：杨春治[1,2] 

机构地区：[1]中国政法大学,北京100088 [2]福建中医药大学,福建福州350108

出　　处：《河北法学》2015年第3期126-134,共9页Hebei Law Science

基　　金：福建省法学会年度重点课题<我国医疗责任保险制度研究>[FLS(2013)A05]的阶段性研究成果

摘　　要：现代医学的发展离不开医学临床试验的前期支持,医学临床试验在国内日渐频繁,受试者在其中发挥了很大的作用,但是其权益保护却未得到应有的重视。就医学临床试验而言,受试者的权益保护不仅具有应然意义上的必要性,而且还有实然意义上的重要性,既有理论逻辑的思辨,又有现实困境的驱动。结合医学受试者权益保护的国际实践,我国医学临床试验受试者的权益保护可以从受试者权利保护、伦理机构建设、责任规则原则和保障制度设计等几个方面加以改进。The development of modern medicine cannot do without medical clinical trials＇ earlier period support. In the domestic,medical clinical trials are being more and more frequent,and subjects play an important role. But their rights and interests protection receives little attention. In terms of medical clinical trials,the protections of subjects＇ rights and interests not only have necessity,but also be of importance. It has Important theoretical basis and reality-driven. Combined with international practice of subjects＇ rights and interests protection in medical clinical trials,subjects ＇ rights and interests protection in our country can be improved in the following aspects：rights protection,ethical institution building,principles of liability rules and security system design.

关 键 词：受试者 伦理机构 无过错责任 强制医疗责任保险 医学试验 

分 类 号：DF36[政治法律—宪法学与行政法学]