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人类生殖系基因编辑的域外监管经验研究
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作者 邹亚文 陶应时 《中国医学伦理学》 北大核心 2024年第10期1146-1153,共8页
研究人类生殖系基因编辑的域外监管经验对于完善中国基因编辑治理框架具有重要的借鉴意义。英国和美国在监管机构、法律法规及多团体参与方面已经有了较为成熟的做法。英国通过人类受精和胚胎学管理局(HFEA)将生殖系基因编辑纳入辅助生... 研究人类生殖系基因编辑的域外监管经验对于完善中国基因编辑治理框架具有重要的借鉴意义。英国和美国在监管机构、法律法规及多团体参与方面已经有了较为成熟的做法。英国通过人类受精和胚胎学管理局(HFEA)将生殖系基因编辑纳入辅助生殖的监管范畴,而美国主要由食品药品监督管理局(FDA)和国立卫生研究院(NIH)两机构负责监管。两国的经验表明,人类生殖系基因编辑的监管框架需要有明确划分职责的监管机构,也需要分类的管理和及时调整修订滞后的法律法规来应对技术的发展和伦理挑战。在此基础上,提出借鉴国际和国家各种组织的咨询,增加公众参与对于建立正确的价值观至关重要。建议中国应明确机构监管职责,制定行之有效的法律法规条款,并促进多方对话和公众参与等。 展开更多
关键词 人类生殖系 基因编辑 域外监管
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我国人类生殖系基因组编辑治理框架的问题及其完善 被引量:7
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作者 胡新平 石佳友 《经贸法律评论》 2022年第1期19-37,共19页
“基因编辑婴儿”事件集中暴露了我国人类生殖系基因组编辑规制体系的不足,该事件发生后,我国在立法上对基因编辑技术和涉及人的生命科学研究作出了一系列回应,但现行治理框架仍存在具体问题尚待解决,包括立法层级低、可操作性欠缺、分... “基因编辑婴儿”事件集中暴露了我国人类生殖系基因组编辑规制体系的不足,该事件发生后,我国在立法上对基因编辑技术和涉及人的生命科学研究作出了一系列回应,但现行治理框架仍存在具体问题尚待解决,包括立法层级低、可操作性欠缺、分类分阶段治理不明确、立法滞后、公众参与不足等。在考察人类生殖系基因组编辑规制的域外经验的基础上,建议我国将现有的规范性法律文件内容进行整合,上升到法律位阶进行专门立法;细化基因编辑的分类分阶段治理;为保持规制的活力和有效性,加强软法规则的建设;增加科技领域立法的透明度,强化公众参与。 展开更多
关键词 人类生殖系基因组编辑 可遗传基因组编辑 场景化治理 域外经验
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论人类生殖系基因组编辑的私法规制
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作者 王康 《法律科学(西北政法大学学报)》 CSSCI 北大核心 2024年第5期59-72,共14页
在《民法典》第1009条的规制范围中,人类生殖系基因组编辑的伦理、法律问题最为复杂。本条作为对人类生殖系基因组编辑进行直接规制的唯一条款,本质上系聚焦义务施加的框架性条款,仅是“新条文”而非“新规则”,但有“新意义”。为在私... 在《民法典》第1009条的规制范围中,人类生殖系基因组编辑的伦理、法律问题最为复杂。本条作为对人类生殖系基因组编辑进行直接规制的唯一条款,本质上系聚焦义务施加的框架性条款,仅是“新条文”而非“新规则”,但有“新意义”。为在私法领域实现对前沿生命科技的国家治理政策目标,其对人类生殖系基因组编辑技术应用发出禁令,并采取了风险、伦理与利益三个虽不充分但却务实的规制路径,展示出谨慎、包容、谦抑的规制立场。本条因包含转介条款而具有法源指引和拓展之功能,借助将有关管制法条款的规范位阶提升,可形成一个有关人类生殖系基因组编辑的公法、私法交融的动态规制体系。本条因其一般条款的性质而存在着适用上的风险和负担,需经具体化之司法作业才能发挥应有的规范力,故不能过高评价其法价值和法效果。本条尚需在法的外在体系、内在体系上予以立法改进和法理阐释,才能真正实现规范目的,在人类生殖系基因组编辑法律规制中彰显以人之尊严为价值内核的基因正义。 展开更多
关键词 人类生殖系基因组编辑 人之尊严 基因正义
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Transnationalization on the Technique of Assisted Human Reproduction
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作者 Edna Raquel Hogemann 《Sociology Study》 2014年第3期262-268,共7页
This paper's purpose is to present a reflective analysis about the process of transnationalization in which the technique of assisted human reproduction has been going to the extent that such a procedure has been rev... This paper's purpose is to present a reflective analysis about the process of transnationalization in which the technique of assisted human reproduction has been going to the extent that such a procedure has been revealed as a true "fertility tourism", offered through packages for those people who have financial conditions, but cannot through natural means to realize the dream of membership. Through the dialectic method of discourse, promoting the comparison of the thought of many authors who focus on issues such as globalization, commodification of human, technical exacerbation detriment of humans, and their interpersonal relations, the author seeks to introduce issues that are the order of day with respect to this global market arising from the tremendous advances reproductive techniques in a society marked by economic interests, it turns much more to the consumer and considers the human being as an additional asset to be sold, since its conception. The author acknowledges that they cease for tourism human reproduction is a trade that is worth of human frailty, because relying on one of the most intimate aspects of life: the desire to be a mother or father or ultimately, the perpetuation of the species. 展开更多
关键词 Transnationalization assisted reproduction TRADE
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端粒和端粒酶在生殖领域的研究进展 被引量:2
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作者 杜坤 董悦芝 周飞京 《中华生殖与避孕杂志》 CAS CSCD 北大核心 2020年第5期434-438,共5页
端粒是染色体末端的DNA-蛋白质复合体,端粒的长度决定了细胞的寿命;端粒酶是具有延长端粒长度的逆转录酶。外周血白细胞及人类生殖系细胞中都有端粒及端粒酶活性的表达。研究显示端粒及端粒酶活性与胚胎发育异常及不孕不育有关,明确端... 端粒是染色体末端的DNA-蛋白质复合体,端粒的长度决定了细胞的寿命;端粒酶是具有延长端粒长度的逆转录酶。外周血白细胞及人类生殖系细胞中都有端粒及端粒酶活性的表达。研究显示端粒及端粒酶活性与胚胎发育异常及不孕不育有关,明确端粒、端粒酶与不孕不育的关系可为一些疾病的治疗带来指导意义。本文就端粒及端粒酶在生殖领域研究进展方面作一综述。 展开更多
关键词 端粒 端粒酶 人类生殖系细胞 外周血白细胞 不孕不育
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Experiments that led to the first gene-edited babies: the ethical failings and the urgent need for better governance 被引量:12
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作者 Jing-ru LI Simon WALKER +1 位作者 Jing-bao NIE Xin-qing ZHANG 《Journal of Zhejiang University-Science B(Biomedicine & Biotechnology)》 SCIE CAS CSCD 2019年第1期32-38,共7页
The rapid developments of science and technology in China over recent decades, particularly in biomedical research, have brought forward serious challenges regarding ethical governance. Recently, Jian-kui HE, a Chines... The rapid developments of science and technology in China over recent decades, particularly in biomedical research, have brought forward serious challenges regarding ethical governance. Recently, Jian-kui HE, a Chinese scientist, claimed to have "created" the first gene-edited babies, designed to be naturally immune to the human immunodeficiency virus(HIV). The news immediately triggered widespread criticism, denouncement, and debate over the scientific and ethical legitimacy of HE’s genetic experiments. China’s guidelines and regulations have banned germline genome editing on human embryos for clinical use because of scientific and ethical concerns, in accordance with the international consensus. HE’s human experimentation has not only violated these Chinese regulations, but also breached other ethical and regulatory norms. These include questionable scientific value, unreasonable risk-benefit ratio, illegitimate ethics review, invalid informed consent, and regulatory misconduct. This series of ethical failings of HE and his team reveal the institutional failure of the current ethics governance system which largely depends on scientist’s self-regulation. The incident highlights the need for urgent improvement of ethics governance at all levels, the enforcement of technical and ethical guidelines, and the establishment of laws relating to such bioethical issues. 展开更多
关键词 Jian-kui HE Human germline gene editing Human immunodeficiency virus (HIV) Clustered regularly interspaced short palindromic repeat (CRISPR)-Cas9 Ethical review
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