论医学人体试验受试者权益的法律保护  

On the Legal Protection for the Rights and Interests of Medical Human Trial Subjects

作　　者：刘丹茹[1] 张雪[1] 尹梅[1] 

机构地区：[1]哈尔滨医科大学人文社会科学学院

出　　处：《医学与法学》2013年第4期68-71,共4页Medicine and Jurisprudence

基　　金：四川医事卫生法治研究中心立项资助项目"临床知情同意书规范性践行模式研究"(项目编号:YF12Z02);哈尔滨医科大学伍连德青年科学基金项目"伦理审查委员会(IRB)跟踪审查制度作用机制的研究与实践"(项目编号:WLD-QN08)的阶段性成果

摘　　要：在世界范围内医学人体试验已经日渐趋于法律规范化,我国也试图通过法律手段来调控医学人体试验并作出了积极的探索。但要达到与生命科学发展相适应的水平,我国的相关法律制度尚存在诸多不足甚至立法空白。从"医学人体试验受试者权益"的概念和其重要内容出发,简要介绍国外较为先进的法律制度,借鉴国际经验从加强试验监管、完善经济保障、健全人体试验立法等角度对我国现存问题提出法律对策。Medical human trials have been increasingly becoming legally standardized worldwide, and we are trying to regulate medical human trials by legal means and have made positive exploration in China. But there are still many deficiencies and even legislative blank in the relevant legal system in our country if we want achieve the level which adapts to the development of life science. In this paper, the author starts from the definition and important contents of the rights and interests of medical human trial subjects, briefly introduces advanced foreign legal systems, argues that we should learn from other countries, and puts forward legal countermeasures on the ex- isting problems in our country from the following perspectives： strengthening the supervision of trials; improving economic security; and improving the legislation of human trials, etc..

关 键 词：医学人体试验 受试者权益 法律保护 

分 类 号：D921[政治法律—宪法学与行政法学] D922.16[政治法律—法学] D923