摘要
受试者的权利保护是人体试验活动中最核心的伦理和法律问题。国内外法律法规对受试者权利的保护作出了若干规定。基于最新颁布的《涉及人的生命科学和医学研究伦理审查办法》,从受试者的生命健康权、知情权与自主决定权、隐私权、获得补偿与赔偿权四个方面,梳理我国医学科学研究中受试者权利保护的政策和现状,发现存在法律体系不健全、制度落实有差距、行政监管不到位等问题。建议完善受试者权利保护的法律体系,加大行政监管力度,建立起受试者全方位保护的网络。
The protection of subjects'rights is the most central ethical and legal issue in human trial activities.Domestic and foreign laws and regulation have made several provisions for the protection of subjects'rights.Based on the newly promulgated Measures for Ethical Review of Life Sciences and Medical Research Involving Human Subjects,this paper sorts out the policies and current situation of the protection of subjects'rights in medical scientific research in China from four aspects:subjects'right to life and health,right of informed consent and self-ditermination,right to privacy,and right to compensation and reimbursement.It is found that there are problems such as imperfect legal system,gaps in system implementation,and inadequate administrative supervision.It is recommended to improve the legal system for the protection of subjects'rights,increase administrative supervision,and therefore establish a comprehensive protection network of subjects.
作者
杨竟
陈勇川
YANG Jing;CHEN Yong-chuan(Party Committee Office,Chongqing Emergency Medical Center,Chongqing 400014,China)
出处
《医学与哲学》
北大核心
2023年第9期1-5,共5页
Medicine and Philosophy
关键词
受试者
权利
《涉及人的生命科学和医学研究伦理审查办法》
subject
rights
Measures for Ethical Review of Life Science and Medical Research Involving Human Subjects
