【摘要】 基因编辑婴儿的行为之所以违反道德和法规,是因为研究者没有把受试者的生命和健康利益放在首位。它从程序非正义开始,以错误的受益/风险评估和无效的伦理审查为凭据,违规实施了可遗传的基因编辑增强临床试验,让无明显受益的婴儿承受了巨大的未知风险。这一事件暴露出我国生物医学伦理规制的某些薄弱环节,诸如机构伦理委员会的权利与其能力、独立性和规范性建设严重不相称;对机构伦理委员会审查失误的补救措施明显不足;相关规范性文件效力层次低,对违规行为处罚过轻等。建议对人类可遗传的基因编辑临床研究项目进行风险评估,对其中的风险较高者增加伦理审查复核机制,对其中的高风险者提交高一级伦理委员会审查,并报请国家卫生健康委员会审批。更多还原

【Abstract】 The reason why the behavior of genetically edited babies violates ethics and regulations is that researchers do not take the life and health of the subjects as the priority. Initiating from procedural injustice and based on false benefit/risk assessments and invalid ethical reviews,it violated the rules by conducting genetic editing-enhanced clinical trials,which exposed infants without any significant benefits to huge unknown risks. This incident has disclosed the following deficient aspects of biomedical ethics regulation in China: 1) the serious disparity between the rights of institutional ethics committees and their ability,independence and normative construction; 2) the obvious inadequacy of remedial measures for the review errors of institutional ethics committees; 3)the low level of validity of relevant normative documents and the light penalties for violations. It is thus suggested that the risk assessment of clinical research projects of human genetic editors be carried out,the mechanism of ethical review be increased for those at higher risk,and those at higher risk be submitted to the higher-level Ethical Committee for examination and approval,and be submitted to the National Health Commission for approval.更多还原