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随着我国社会经济的不断发展和人民健康需求的日益增长,新药进入临床试验的项目越来越多,临床研究特别是真实世界研究的开展也越来越广泛,对受试者权益保护的法律问题逐渐凸显。本文通过对案例的分析,重点对受试者权益保护主体中的伦理委员会及其法律地位、法定职责进行了阐述;提出了当受试者权益受到侵害时,如何确定承担责任的归责原则;并在此基础上提出了商业保险制度与受试者救助基金制度并存等制度构想与建议。
With the continuous development of our society and economy and the increasing demand of people’s health, there are more and more projects that new drugs enter into clinical trials. The clinical research, especially real-world research, is also more and more extensive. The law of protecting the rights and interests of subjects The problem is gradually highlighted. Based on the analysis of the case, this article focuses on the ethics committee and its legal status and legal duties in the subject of rights protection, and puts forward the principle of how to determine the responsibility of the subject when the rights and interests of the subject are infringed. On this basis, the conception and suggestion of the system of commercial insurance and the co-existence of the fund system of the victims’ aid are proposed.