摘要
临床试验是新药物、新疗法在研发过程中一个不可或缺的环节,而受试者作为临床试验法律关系中的弱势群体,其权益极易受到侵害。受试者权益保护以生命伦理学和普遍人权理论为理论基础,具有理论层面的必要性。同时,面对我国当前法律体系不健全、制度不科学等现实困境,推进完善受试者权益保护也具有实践层面的必要性。结合域外临床试验受试者权益保护的有益经验,我国可以从事前立法和实施制度进行规范,以及事后司法进行救济等方面加以完善。
Clinical trials are indispensable links in the development of new drugs and new therapies. While as vulnerable groups in clinical trials in legal relationship, the subjects＇ interests are vulnera- ble to abuse. The protection of the subjects＇ rights and interests is based on the theory of bioethics and universal human rights, and has the necessity of theoretical level. At the same time, in the face of the current legal system that is not perfect, ties, and promoting the protection of subjects＇ the system is not scientific and other realistic difficul- rights and interests also has the necessity of practical level. Combining the beneficial experience outside of the subjects＇ rights and interests protection in the clinical trial of the patients, our country can be engaged in the promotion of legislation and imple- mentation of the system, and the post judicial relief or other aspects.
出处
《重庆理工大学学报（社会科学）》
CAS
2015年第12期97-104,共8页
Journal of Chongqing University of Technology（Social Science）
基金
国家社会科学基金青年项目"公立大学改制为行政法人研究"(CIA100155)
关键词
临床试验
权益保护
生命伦理学
普遍人权理论
无过错责任
clinical trial
protection of right and interest
bioethic
universal human right
no-fauh lia-bility
