2015年4月我国英文学术期刊《蛋白质与细胞》(Potein and Cell)发表了中山大学黄军就副教授关于利用CRISPR/Cas9基因编辑技术对人类胚胎中地中海贫血症致病基因修饰的研究成果,引起了国内外对基因编辑技术及其应用研究的大讨论。本文简...2015年4月我国英文学术期刊《蛋白质与细胞》(Potein and Cell)发表了中山大学黄军就副教授关于利用CRISPR/Cas9基因编辑技术对人类胚胎中地中海贫血症致病基因修饰的研究成果,引起了国内外对基因编辑技术及其应用研究的大讨论。本文简要介绍了几种不同的基因组编辑技术的原理,比较分析了它们的优缺点。由于ZFNs和TALENs相对低效有更容易发生脱靶等缺点,而NgAgo基因编辑技术在几个月之前刚刚发表,目前的研究文献不多,因此本文主要总结了CRISPR/Cas基因编辑技术的研究进展,对其疾病基因治疗的应用前景进行了展望,同时对涉及的伦理和相关法规建设问题进行了分析并对监管机构制定政策提出了有益建议。展开更多
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
文摘2015年4月我国英文学术期刊《蛋白质与细胞》(Potein and Cell)发表了中山大学黄军就副教授关于利用CRISPR/Cas9基因编辑技术对人类胚胎中地中海贫血症致病基因修饰的研究成果,引起了国内外对基因编辑技术及其应用研究的大讨论。本文简要介绍了几种不同的基因组编辑技术的原理,比较分析了它们的优缺点。由于ZFNs和TALENs相对低效有更容易发生脱靶等缺点,而NgAgo基因编辑技术在几个月之前刚刚发表,目前的研究文献不多,因此本文主要总结了CRISPR/Cas基因编辑技术的研究进展,对其疾病基因治疗的应用前景进行了展望,同时对涉及的伦理和相关法规建设问题进行了分析并对监管机构制定政策提出了有益建议。
基金Project supported by the National Natural Science Foundation of China(No.L1824000)
文摘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.
