法律视域下药物临床试验受试者的权益保护  

Protect the Rights and Interests of the Subjects with the Clinical Trials of Drugs from the Legal Perspective

作　　者：孙同波[1] 尹梅[1] 张雪[1] 钟岩[1] 徐文轩[1] 

机构地区：[1]哈尔滨医科大学,黑龙江哈尔滨150081

出　　处：《中国医院管理》2016年第4期73-74,共2页Chinese Hospital Management

基　　金：南京医科大学人文协同创新中心项目(JX21831802/006/006);哈尔滨医科大学伍连德青年科学基金项目(WLD-QN08)

摘　　要：对药物临床试验进行法律规制,最大限度地保护受试者合法权益,让医学研究运行在为人类造福的正确轨道上,已经成为了必须面对的现实课题。有鉴于此,从药物临床受试者权益的范畴出发,在分析和讨论我国药物临床试验受试者保护存在问题的基础上,提出了完善的对策。In order to maximize the protection of the rights and interests of the subjects and let medical research run in the right track for the benefit of mankind, legal regulation of clinical trial of drugs has become a reality issue which we must face. For this reason, the article starts from the categories of the rights and interests of clinical trial of drugs, and analyzes and discusses of the problems of subjects protection in clinical trial of drugs. Finally, the article puts forward the countermeasures to improve it.

关 键 词：药物临床试验 受试者权益 法律 

分 类 号：R95[医药卫生—药学]