“黄金大米”事件的反思——用科学理性和道德规范做好伦理审查

Introspection of "Golden Rice" Incident-Doing Well in Ethical Review with Scientific Rationality and Code of Ethics

"黄金大米"事件所暴露的问题既有伦理委员会本身缺乏道德自律的原因,也有相关法规制度设计上的欠缺。强调伦理委员会对知情同意全过程的监管,在伦理审查中引入问责机制,通过制度设计,使伦理委员会的审查和监督的全过程尽可能实行信息公开,加大审查的透明度,尽快出台涉及人的临床研究法律规范。

The ＂Golden Rice＂ incident exposed the problems not only in the ethics committee, lacking the moral self- discipline, but also the poor designing of relevant laws and regulations. This paper emphasized the whole process of supervision on informed consent, introducing the accountability mechanism into the ethical review, publishing the information of the whole process of review and supervision through the design of the system in the ethics committee, increasing the transparency of ethical review, promulgating laws on human body experiments as soon as possiable.