体外人胚胎研究“14天规则”亟待调整：基于科学、伦理、政策的综合视角分析

The 14-day rule for in vitro human embryo research requires adjustment: From a comprehensive perspective of science, ethics and policy research

        鲁晓^1,2(中国科学院科技战略咨询研究院 北京 100190;中国科学院大学 公共政策与管理学院 北京 100049)
        赵铭^1,2(中国科学院科技战略咨询研究院 北京 100190;中国科学院大学 公共政策与管理学院 北京 100049)
        刘慧晖¹(中国科学院科技战略咨询研究院 北京 100190)
        李天晴³(昆明理工大学 灵长类转化医学研究院/省部共建非人灵长类生物医学国家重点实验室 昆明 650500)
        谭韬³(昆明理工大学 灵长类转化医学研究院/省部共建非人灵长类生物医学国家重点实验室 昆明 650500)
        季维智^3*(昆明理工大学 灵长类转化医学研究院/省部共建非人灵长类生物医学国家重点实验室 昆明 650500)

         体外人胚胎研究;伦理规制;“14天规则”;沃诺克报告

        in vitro human embryo research;ethical regulation;14-day rule;Warnock Report

        长期以来，国际科学界在体外人胚胎研究领域所遵循的“14天规则”，将人胚胎体外研究时间限制在受精后的14天内，这是该研究领域最重要的伦理规则。随着胚胎培养技术的发展，这一伦理规则受到前所未有的挑战。2021年，国际干细胞研究学会（ISSCR）在《干细胞研究和临床转化指南》中建议有条件地放宽这一限制，科学界重启关于“14天规则”的讨论。文章以“14天规则”为切入点，系统梳理人胚胎研究伦理规制的历史背景和现实挑战，围绕人胚胎的道德地位、尊严和法律地位等关键伦理问题进行分析，全面分析各界利益相关者的观点和态度，从而结合实际做出评估，明确提出审慎、适当延长“14天规则”的政策建议和具体措施。

        Since it was proposed, in vitro human embryo research had been following the 14-day rule, which limited in vitro research on human embryos within 14 days after fertilization. With the advancement in embryo culturing technology, this ethical rule has been greatly challenged. In 2021, the International Society for Stem Cell Research (ISSCR) recommended a conditional extension of the existing time limit in ISSCR Guidelines for Stem Cell Research and Clinical Translation, hence the international scientific community has restarted the debate on the 14-day rule. This study systematically analyzed the historical background and controversies of the 14-day rule ethical regulation of human embryo research, as well as revisited the core ethical issues of the moral status, dignity, and legal status of human embryos as research subjects. It also comprehensively examined the attitudes of different stakeholders in responding to the relaxation of current regulations and raised policy agenda and suggestions in extending the time limit of human embryo research.