涉及人的生物医学研究伦理审查制度立法进程及其特征分析

Analysis on the Legislative Process and Characteristics of Human-Related Biomedical Research Ethics Review System

对涉及人的生物医学伦理审查立法进行梳理,依据权利制度变化和重大标志性法律文件的出台,并结合国内外临床试验发展,将其划分为四个阶段,认为中国伦理审查立法进程具有以下特征:从规范化临床试验转变为以受试者保护为核心的制度内涵,审查范围随着科技和认知发展逐步明确,逐步加强知情同意的审查,日益重视审查效率,逐步加强监管,明确法律责任。基于立法现状和我国国情提出应从统一伦理审查法律规范和要求,加强伦理审查的内外部监管,加大违反伦理审查相关规定的处罚等方面进一步完善立法,加大受试者权益保护。

According to transformed of rights and system and the issuance of major landmark legal documents and combined with domestic and foreign clinical trial development,this study sorted out the legislation of the ethical review of the biomedical research involving human,dividing it into four stages.It’s believed that the legislation has following characteristics:the core of the system transformed from standardized clinical trial to the protection of the participants’right;the scope of the review is gradually clarified with the development of science and technology;the review of informed consent is gradually strengthened;the efficiency of review is increasingly emphasized;supervision is gradually strengthened;clearing legal responsibilities.Based on the current legislative situation and national conditions,it is proposed to unify the requirements of ethics review,strengthen internal and external supervision of ethics review and increase penalties for violations of ethics review regulations to improve the protection of participants’rights and interests.