转基因食品人体试验的法律规制——基于“黄金大米”事件的宪法分析

Legal Regulation of Human Trials of Genetically Modified Foods:A Constitutional Analysis Based on the Golden Rice Case

"黄金大米"事件的曝光引发了人们对于转基因食品人体试验的法学思考。在该转基因食品人体试验中,参与试验学生的尊严、生命权、健康权、知情同意权都受到了一定的侵害。现阶段,我国存在着许多违法的生物医学人体试验,这严重侵害了受试者的权益。目前,我国尚未有专门的法律对人体试验进行规制,人体试验中受试者权利易受侵害,而通过市场的外在调节,难以达到有效规范人体实验、保护受试者的人权的目的,因而需要制定专门的《人体试验法》。该法律应该以保障人的尊严为原则,以受试者人权保护为核心,同时在程序上应执行伦理委员会审查和卫生行政部门许可的双审制度。

The exposure of Golden Rice Case caused people to think about human trials of genetically modified foods.In this human trial,human dignity,right to life,right to health,and privacy of students participating in the trial were violated.At present,there are plenty of illegal biomedical human trials in China,which invade the interests of the subjects.There are not any specified laws regulating of human trials.The subjects＇ rights are vulnerable.However,by the external regulation of market,it is impossible to regulate human trials effectively and protect subjects＇ interests.Therefore,it is necessary to enact Human Trails Act and make special provisions for human trials of genetically modified food.The law bases on the principle of human dignity,with the protection of subjects＇ human rights at it＇s core.By reviewing of the Institutional Review Board and license system executed by health administrative departments,the law aims to protect the subjects＇ human rights.