Human germline gene editing. Recommendations of ESHG and ESHRE†‡

Human germline gene editing. Recommendations of ESHG and ESHRE†‡
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ESHG 和 ESHRE 的建议†‡ 人类种系基因编辑。

DOI:
10.1093/hropen/hox025
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发表时间:
2018
影响因子:
8.3
通讯作者:
M. Cornel
M. Cornel
中科院分区:
医学2区
文献类型:
--
作者:
G. de Wert;G. Pennings;A. Clarke;U. Eichenlaub;C. V. van El;F. Forzano;M. Goddijn;B. Heindryckx;H. Howard;D. Radojkovic;E. Rial‐Sebbag;B. Tarlatzis;M. Cornel

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摘要基因编辑的技术发展对临床应用提出了很高的期望,首先是体细胞基因编辑,但在理论上也适用于种系基因编辑(GLGE)。目前,许多国家不允许GLGE。这使得这些国家的临床应用现在不可能,即使GLGE将变得安全和有效。这项立法背后的论据是什么,它们仍然令人信服吗?如果一项技术可以安全有效地帮助避免严重的遗传疾病,这是否会成为重新考虑先前观点的理由?欧洲人类生殖与胚胎学学会(ESHRE)和欧洲人类遗传学学会(ESHG)共同制定了一份背景文件和建议,以告知和激发正在进行的社会辩论。在咨询其成员和专家后,该建议书的最终版本于2017年5月获得各协会执行委员会和董事会的批准。考虑到伦理争论,我们认为,基础和临床前研究人类GLGE可以合理,有条件。此外,虽然临床GLGE完全为时过早,但它可能在未来成为一种负责任的干预措施,但只有在充分的临床前研究之后。儿童和子孙后代的安全是一个主要问题。未来的讨论还必须解决生殖和潜在的非生殖替代方案之间的优先事项,如PGD和体细胞编辑,如果这是安全和成功的。然而,禁止人类生殖系修改需要相关利益攸关方,包括公众和立法者之间重新讨论。
Abstract Technological developments in gene editing raise high expectations for clinical applications, first of all for somatic gene editing but in theory also for germline gene editing (GLGE). GLGE is currently not allowed in many countries. This makes clinical applications in these countries impossible now, even if GLGE would become safe and effective. What were the arguments behind this legislation, and are they still convincing? If a technique can help to avoid serious genetic disorders, in a safe and effective way, would this be a reason to reconsider earlier standpoints? The European Society of Human Reproduction and Embryology (ESHRE) and the European Society of Human Genetics (ESHG) together developed a Background document and Recommendations to inform and stimulate ongoing societal debates. After consulting its membership and experts, this final version of the Recommendations was endorsed by the Executive Committee and the Board of the respective Societies in May 2017. Taking account of ethical arguments, we argue that both basic and pre-clinical research regarding human GLGE can be justified, with conditions. Furthermore, while clinical GLGE would be totally premature, it might become a responsible intervention in the future, but only after adequate pre-clinical research. Safety of the child and future generations is a major concern. Future discussions must also address priorities among reproductive and potential non-reproductive alternatives, such as PGD and somatic editing, if that would be safe and successful. The prohibition of human germline modification, however, needs renewed discussion among relevant stakeholders, including the general public and legislators.