论医学人体试验双重审查机制的构建  

On the Construction of Two-tiered Review System of Clinical Trial

作　　者：冯林林 陈小嫦 FENG LINLIN;CHEN XIAOCHANG(School of Humanities and Management, Guangdong Medical University, Dongguan, 523808, China)

机构地区：[1]广东医科大学人文与管理学院

出　　处：《西安电子科技大学学报（社会科学版）》2019年第2期1-5,共5页Journal of Xidian University：Social Science Edition

基　　金：广东省哲学社会科学“十二五”规划2014年度学科共建项目“人体试验当事人利益冲突的解决机制研究”(GD14XGL10);广东省创新强校工程2017年度特色创新类项目(人文社科)“人体试验风险管理的制度规制”(2017WTSCX046)

摘　　要：医学人体试验为高危行为,而这种高危行为不仅涉及的是自然人的基本权利——生命权和健康权,并且与公共利益联系密切。这些危险发生的后果,从公共安全角度而言,是属于系统性问题,从自然人权利救济角度而言,无法事后进行补救。因此,从控制危险的角度,以及从医学人体试验涉及的权利性质的角度而言,应当对医学人体试验实行行政许可。医学人体试验的审查应当为伦理委员会伦理审查、有权机关行政许可的双重审查机制。Clinical trial is a high-risk behavior, and it involves not only the basic rights of natural personsthe right to life and health, but also the public interest. The consequences of these dangers are systemic in terms of public safety and cannot be remedied afterwards from the perspective of natural person's rights relief. Therefore, administrative licenses should be applied to clinical trials from the perspective of controlling hazards and from the nature of the rights involved. A Two-tiered Review System shall be established, including the ethical review of the ethics committee and the administrative license of the competent authority.

关 键 词：医学人体试验 行政许可 伦理审查 

分 类 号：R-052[医药卫生]