CAJ | 학술논문

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。
수시자권익보호시의학윤리학적핵심，종“subject”일사적유래급기한역적연변과정，분석국내외대수시자자주성중시정도적불동。수시자적자주의식시림상시험순리완성적중요인소，천술료미국상관법규급수시자자주권익보호현상，병결합아국국정종수시자각도진행분석，제출가강수시자자주권익보호적중요성；병종림상시험지식적보급、개진수시자권리적고지방식급수시자자주권리적행사등방면제출가행성건의，이기완선수시자권익보호공작。
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;secondly proposed the importance of strengthening the subjects’ rights protection according to China’s own problems from the perspectives of 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 .