论人体试验中受试者的知情同意权——从“黄金大米”事件切入

Study on the Right of Informed Consent of Subjects in Human Trials——As the breakthrough point with the“Golden Rice events”

在"黄金大米"事件中,研究者严重侵害了受试者的知情同意权。对此进行反思,中国相关立法存在研究者告知标准未确立,对未成年受试者缺乏特别保护及民事责任缺失等问题。对此应确立研究者之"理性受试者"告知标准;对未成年受试者采用"双重同意"模式;同时规定侵害受试者知情同意权的独立请求权,使受试者的知情同意权成为"有救济的真正的权利"。

In the ＂Golden Rice events＂, the researchers seriously infringe the right of informed consent of subjects. On reflection, there are some problems that lack of the researchers＇ informing standard, the special protection to the minor subjects and the civil liability to the researchers in China. We should establish the rational subjects＇ standards to the researchers informing. About minor subjects, we must adopt the dual consent model. And we must provide the subjects＇ independent right of claim to infringement of the right of informed consent. That will make the subjects right of informed consent has a real meaning.