读医学网

        在第二届人类基因组编辑国际峰会(香港)即将召开之际，大会组委会获悉，中国诞生了一对被胚胎基因组编辑的双胞胎，而领导这项研究的研究员也即将在本次峰会(周三)上发言。

        可遗传的基因组编辑临床试验，一直是许多研究小组争论和探讨的热点话题，目前已经有大量的研究证据，为进行可遗传的基因组编辑临床试验提供了有力的理论证据和研究基础。美国国家科学院、工程与医学科学院2017年发表的报告中写道，在临床前研究充分阐明潜在的风险和益处，并且通过同行评审的情况下，这类的临床研究可能会被批准。但这仅仅是在没有更有效的治疗手段情况下，人们选择更先进医学手段的方式，但不得不提到的是，这些研究提供的手段只是一类可以选择的替代方式，而在临床研究进行的整个过程中，必须要做到高度的透明化，并且需要经历严格的监督和审查。此外，报告还提到，在进行这类研究时，我们应该保持谨慎的态度，同时需要广泛征求社会公众的意见和建议，并且在相关部门制定了有效的监管手段(包括研究的标准和结构体系)的情况下，这项研究才是真正有意义和科学的。

        让我们将目光放到欧洲。2018年英国纳菲尔德生物伦理学委员会发布了一份独立调查报告，这份报告明确指出“我们应该建立一个高效的遗传性基因组编辑的干预环境”，这样才能保证人类遗传的安全性。而在中国，导致了这两个孩子出生的临床试验是否符合相关标准，还有待商榷。

        大会组委会希望通过这次高峰论坛的对话，可以进一步增进全世界对人类基因组编辑相关研究问题和伦理问题的认识和理解，而我们的目标是确保人类基因组编辑安全、合理、有效且负责地进行，并且造福全社会。

        联系方式：

        莫莉·高尔文(Molly Galvin)

        公共信息和新闻办公室

        美国国科学院院，工程与医学院

        电子邮箱：mgalvin@nas.edu

        联系电话： +1-202-731-2841

        声明原文如下：

        Nov. 26， 2018

        Statement from the Organizing Committee on Reported Human Embryo Genome Editing

        HONG KONG -- On the eve of the Second International Summit on Human Genome Editing， we were informed of the birth of twins in China whose embryonic genomes had been edited. The researcher who led the work， He Jainkui， is scheduled to speak at the summit on Wednesday.

        The criteria under which heritable genome-editing clinical trials could be deemed permissible have been the subject of much debate and discussion by many research groups. Numerous studies have provided guidance for the conduct of heritable genome-editing clinical trials. One such study， a 2017 report by the U.S. National Academies of Sciences， Engineering， and Medicine， concluded that clinical trials might be permitted after peer-reviewed preclinical research further clarifies the potential risks and benefits， only for compelling medical reasons in the absence of reasonable alternatives， and with maximum transparency and strict oversight. The report noted that such research should be approached with caution and with broad public input. It specified a regulatory framework that included ten recommended criteria and structures. A second major report， released in 2018， which was the result of an independent inquiry by the Nuffield Council on Bioethics in the U.K.， also specifies “circumstances in which heritable genome editing interventions should be permitted.” Whether the clinical protocols that resulted in the births in China conformed with the guidance in these studies remains to be determined.

        We hope that the dialogue at our summit further advances the world’s understanding of the issues surrounding human genome editing. Our goal is to help ensure that human genome editing research be pursued responsibly， for the benefit of all society.

        Contact：

        Molly Galvin

        Office of News and Public Information

        U.S. National Academies of Sciences， Engineering， and Medicine

        mgalvin@nas.edu

        Mobile： +1-202-731-2841