医学研究受试者权利及其保护的基本问题

Fundamental Issues of Rights of Human Subjects in Medical Research

以权利法学理论为基础,借鉴域外立法经验,对受试者权利保护的应然性问题进行研究,以期有利于转变医学试验参与者的观念,为相关制度完善提供建议。受试者以自己的生命健康风险为代价参与医学研究有其伦理正当性,其权利应当予以充分保护;受试者在社会生活及研究活动中均处于弱势地位,应当遵循特别保护原则;对心智不全者的人体试验在医学发展中是必要的,但应当在正常受试群体不能替代的情况下才能予以开展,并采取严格审查措施;受试者权利具有人权属性,立法保护应当体现其神圣性。

Based on theory of legal right and foreign legislative experience, this article studied human subjects rights in medical research in order to change subjectss＇ view towards medical research and promote the regulation system. The ethical legitimacy for human subjects to participate in research at the risk of their own lives is based on the fully protection of their rights. As vulnerable people in society and research, human subjects deserve additional protections. The enrollment of mental impaired subjects can only be justified by their irreplaceable recruitment of other healthy volunteers into medical research. At the same time, the stringent ethical review should be implemented. Because of the nature of human rights, the protection of human subjects should embody sanctity.