美国人体研究知情同意对我国的启示

Enlightenment of Informed Consent of American Human Research to China

随着人们自主意识的增强,知情同意在人体研究中的地位越发显得重要,而我国在知情同意的践行上还存在许多需要改进的地方:相关的法律规范位阶偏低;研究者告知的内容不完善;弱势群体法律规范过于笼统;人体研究知情同意监管力度不够。知情同意诞生于英美法系,通过研究美国在人体研究知情同意上的政策,立足于我国的国情提出以下解决方案:提高人体研究法律规范位阶,完善告知的内容;细化对未成年受试者知情同意的特殊规定;加强对人体研究知情同意的监管;完善人体研究知情同意跟踪审查机制。

With the enhancement of people’s self-awareness,the status of informed consent in human research is becoming more and more important. However,there are still many areas to be improved in the practice of informed consent in China: low rank of relevant legal norms; imperfect content of researchers’ information; too general legal norms of vulnerable groups; insufficient supervision of informed consent in human research. Informed consent was born in the Anglo-American legal system. By studying American policy on informed consent in human research,this paper put forward the following solutions based on China’s national conditions: improving the legal norms of human research,and improving the content of informed consent; refining the special provisions on informed consent of minor subjects; strengthening the supervision of informed consent in human research and improving the follow-up review mechanism of informed consent in human research.