Legal Protection of the Right of Informed Consent of the Subjects of Human Clinical Trials in China  

作　　者：孟祥菡 SHFN Jinjun MENG Xianghan;SHFN Jinjun(the Law School, Renmin University of China;不详)

机构地区：[1]the Law School, Renmin University of China [2]不详

出　　处：《The Journal of Human Rights》2022年第1期177-196,共20页人权（英文版）

摘　　要：The “informed consent principle” in human clinical trials is the product of the extension of the concept of human rights in the field of human trials and a reflection of the progress of human civilization in biomedical research. In recent years, the legal protection of the right to informed consent for research subjects has been gradually improved in China. The right to informed consent for research subjects has been improved from an ethical norm to a legal norm. The legal status of legal norms has also been gradually improved. Based on the public law regulations, private law relief has been added to the legal relief system for the infringement of the right to informed consent for research subjects. As a result, the protection of rights has been enhanced. The domestic informed consent protection system is partially in line with international norms. The protection of the right to informed consent depends on the perfection of the legal system and the social consensus to respect human rights and the right to self-determination.

关 键 词：SUBJECTS right to informed consent obligation to inform human clinical trials 

分 类 号：D621.5[政治法律—政治学] D923[政治法律—中外政治制度] R951[医药卫生—药学]