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中国人类生殖系基因组编辑的负责任治理。

Responsible governance of human germline genome editing in China†.

机构信息

State Key Laboratory of Stem Cell and Reproductive Biology, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.

Institute for Stem Cell and Regeneration, Chinese Academy of Sciences, Beijing, China.

出版信息

Biol Reprod. 2022 Jul 25;107(1):261-268. doi: 10.1093/biolre/ioac114.

Abstract

Considerable improvements have been made to gene editing technology, which has been increasingly applied to research involving humans. Nevertheless, human heritable germline genome editing is associated with a series of potential ethical, legal, and social risks, which have generated major controversies and discussions worldwide, especially after the "gene-edited babies" incident. Influenced by this incident, China has realized the importance of ethical governance in the field of life science and technology, has accelerated legislative and policy efforts in this field, and has gradually moved toward the direction of "precautionary" ethical governance. Black letter analysis, big data public opinion analysis, and other research methods are used in this paper. This paper explores the scientific background, ethical debates, and latest developments regarding China's regulatory framework for human germline gene editing after the "gene-edited babies" controversy and provides several recommendations on the future governance system of human germline gene editing in China. This paper argues that in recent years, the ethics governance of germline genome editing in China has been accelerated and great changes have been made. However, the regulatory system for germline genome editing requires further improvement in three aspects: coordination of legislation and agencies, establishment of an ethics review system at high levels, and public participation and education.

摘要

基因编辑技术取得了长足的进步,越来越多地应用于涉及人类的研究。然而,人类可遗传生殖系基因组编辑与一系列潜在的伦理、法律和社会风险相关联,这在全球范围内引发了重大争议和讨论,尤其是在“基因编辑婴儿”事件之后。受这一事件的影响,中国认识到生命科学和技术领域伦理治理的重要性,加快了这一领域的立法和政策努力,逐步朝着“预防”伦理治理的方向发展。本文采用实证分析、大数据舆情分析等研究方法,探讨了“基因编辑婴儿”事件后中国人类生殖系基因编辑的监管框架的科学背景、伦理争议和最新进展,并对中国人类生殖系基因编辑的未来治理体系提出了几点建议。本文认为,近年来,中国生殖系基因组编辑的伦理治理得到了加速,发生了重大变化。然而,生殖系基因组编辑的监管体系在三个方面需要进一步改进:立法和机构的协调、建立高层级的伦理审查制度以及公众的参与和教育。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cbb0/9310509/64cdb5631c0f/ioac114ga.jpg

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