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

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.

我国人体临床试验受试者知情同意权的法律保护

人体临床试验中的“知情同意原则”是人权理念在人体试验领域延伸的产物,也是人类文明进步在生物医学研究中的反映。近年来,我国受试者知情同意权的法律保护逐渐完善。受试者的知情同意由伦理规范上升为法律规范,法律规范位阶逐步上升,受试者知情同意权被侵犯后的法律救济制度在公法规制的基础上增加了私法救济,权利保护有更加全面的趋势。国内知情同意权保护制度与国际规范实现部分接轨。受试者知情同意权的保障既要依靠法律制度的完善,也有赖于尊重人权、尊重自我决定权的社会共识的形成。

《联合国反腐败公约》:预防和打击腐败的全球性法律文件

针对腐败日益严重且呈现跨国化、全球化的特点,为更有效地预防和打击腐败,联合国大会于2003年通过了《联合国反腐败公约》。《联合国反腐败公约》是预防和打击腐败方面最重要的全球性法律文件。生效10年来,其权威性和影响力不断增强。《联合国反腐败公约》确立了国际反腐败的预防、刑事定罪与执法、国际合作、资产追回、履约监督等五大法律机制,并在实施的过程中建立起履约审议机制。中国积极参加《联合国反腐败公约》的制定,认真履行缔约国义务,反腐败工作取得重大进展。