论我国转基因动物器官移植人体试验监管制度

Study on the Human Trials Regulatory System of Transgenic Animal Organ Transplants in China

人体试验是转基因动物器官移植走向临床应中用的必经阶段。为维护受试者的生命健康安全,保障试验研究的科学进行,转基因动物器官移植人体试验需要法律的严格监管。目前学界专门针对转基因动物器官移植人体试验的法律监管制度研究很不充分。通过对我国转基因动物器官移植人体试验相关法律监管制度进行梳理,揭示对其进行专门研究的必要性,确立转基因动物器官移植人体试验的基本原则,进而提出具体而有针对性的制度建议。

Human trials of transgenic animal organ transplant is a crucial stage to be clinical application. In order to preserve the life safety and body healthy of the subjects, and promote the scientific research, human trials of transgenic animal organ transplant must subjected to severe legal supervision. Currently academic specialized transgenic animal organs for human transplant legal regulatory system research trials are quite suffi- cient. Through collating the relevant legal and regulatory system of human trials of organ transplantation,uncover necessity of specialized research, establish the basic principle of human trials of transgenic animal organ transplants, and then propose a system specific and targeted recommendations.