受试者知情同意伦理审查中的法律要点  

Legal Points in Ethical Review of Subjects Informed Consent

作　　者：刘炫麟 LIU Xuanlin(Medical Security Law and Policy Research Center,China University of Political Science and Law,Beijing 100088,China)

机构地区：[1]中国政法大学医疗保障法律与政策研究中心,北京100088

出　　处：《中国医学伦理学》2022年第11期1188-1195,1213,共9页Chinese Medical Ethics

基　　金：中国政法大学青年教师学术创新团队资助(21CXTD01)。

摘　　要：受试者参与生物医学研究通常需要获得其知情同意,这也是《中华人民共和国民法典》《中华人民共和国基本医疗卫生与健康促进法》《中华人民共和国医师法》等法律所规定的。由于法律的专业性和复杂性,研究者在撰写知情同意书时,常会在法律术语使用、告知义务履行、受试者权益保护三个方面出现不足。伦理委员会在对受试者知情同意书进行伦理审查时,对研究者所存在的上述不足存在着客观能力欠缺或者主观重视程度不够等问题。通过梳理法律要点,并提供校正方案,为伦理审查提供参考。Subjects informed consent are needed in biomedical research,which has been confirmed by the Civil Code of the People s Republic of China,Law of the People s Republic of China on the Promotion of Basic Medical and Health Care,and Law on Doctors of the People s Republic of China.Due to the professionalism and complexity of the law,researchers often have deficiencies in the use of legal terms,the fulfillment of disclosure obligations and the protection of subjects rights and interests when writing informed consent forms.When the ethics committee conducts ethical review on the informed consent form of the subjects,there are some problems such as lack of objective ability or insufficient subjective attention to the above shortcomings of the researchers.By combing the legal points,this paper summarized the correction scheme to provide reference for ethical review.

关 键 词：生物医学研究 受试者 知情同意 伦理审查 权益保护 

分 类 号：R-052[医药卫生]