受试者自主性在临床试验中的重要性——从Subject由来及其汉译演变谈起  

Importance of Subjects' Autonomy in Clinical Research:From the Origin of Subject and Its Chinese Translation

作　　者：陈晓云[1] 李久辉[2] 李佶[1] 郑锦 刘胜[1] 

机构地区：[1]上海中医药大学附属龙华医院医学伦理委员会,上海200032 [2]上海中医药大学医学伦理学教研室,上海200125 [3]上海中医药发展办公室,上海200040

出　　处：《医学与哲学（A）》2015年第6期28-31,47,共5页Medicine & Philosophy:Humanistic & Social Medicine Edition

基　　金：中医药行业科研专项"中医药临床研究伦理审查体系建设与审查技术研究";项目编号:201407001-14;上海市进一步加快中医药事业发展三年行动计划"医学伦理人才培养";项目编号:ZY3-RCPY-3-1058

摘　　要：受试者权益保护是医学伦理学的核心,从"subject"一词的由来及其汉译的演变过程,分析国内外对受试者自主性重视程度的不同。受试者的自主意识是临床试验顺利完成的重要因素,阐述了美国相关法规及受试者自主权益保护现状,并结合我国国情从受试者角度进行分析,提出加强受试者自主权益保护的重要性;并从临床试验知识的普及、改进受试者权利的告知方式及受试者自主权利的行使等方面提出可行性建议,以期完善受试者权益保护工作。Respect the subjects＇ rights and protect their interests are the core values of medical ethics. This article discussed the term of ＂subject＂ and its Chinese translation through analyzing the different attentions to subjects＇ autonomy between China and US. Due to the participants＇ consciousness of autonomy is an important factor for clinical trial, this paper, firstly introduced the US relevant laws and regulations of human subject protection; secondiy proposed the importance of strengthening the subjects＇ rights protection according to China＇s own problems from the perspectives o{ the subjects; thirdly suggested to spread clinical trials knowledge and improve the informed consent process in order to improve the protection of the subjects＇ rights and interests fundamentally.

关 键 词：受试者 自主性 临床试验 权益保护 

分 类 号：R052[医药卫生]