de Wert Guido, Pennings Guido, Clarke Angus, Eichenlaub-Ritter Ursula, van El Carla G, Forzano Francesca, Goddijn Mariëtte, Heindryckx Björn, Howard Heidi C, Radojkovic Dragica, Rial-Sebbag Emmanuelle, Tarlatzis Basil C, Cornel Martina C
Department of Health, Ethics and Society, Research Institutes GROW and CAPHRI, Fac. of Health, Medicine and the Life Sciences, Maastricht University, PO Box 616, 6200 MD Maastricht, The Netherlands.
Department of Philosophy and Moral Science, Bioethics Institute Ghent, Ghent University, Blandijnberg 2, B-9000 Ghent, Belgium.
Hum Reprod Open. 2018 Jan 12;2018(1):hox025. doi: 10.1093/hropen/hox025. eCollection 2018.
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.
基因编辑技术的发展让人们对其临床应用寄予厚望,首先是在体细胞基因编辑方面,但理论上也包括生殖系基因编辑(GLGE)。目前,许多国家不允许进行生殖系基因编辑。这使得在这些国家即使生殖系基因编辑变得安全有效,现在也无法进行临床应用。这项立法背后的论据是什么,它们仍然令人信服吗?如果一种技术能够以安全有效的方式帮助避免严重的遗传疾病,这会成为重新考虑早期立场的理由吗?欧洲人类生殖与胚胎学会(ESHRE)和欧洲人类遗传学学会(ESHG)共同编写了一份背景文件和建议,以告知并推动正在进行的社会辩论。在咨询了其成员和专家后,这份最终版的建议于2017年5月得到了各学会执行委员会和理事会的认可。考虑到伦理论据,我们认为,在满足一定条件的情况下,关于人类生殖系基因编辑的基础研究和临床前研究是合理的。此外,虽然临床生殖系基因编辑目前还为时过早,但未来可能会成为一种负责任的干预手段,但前提是要有充分的临床前研究。儿童和后代的安全是一个主要问题。未来的讨论还必须涉及生殖和潜在的非生殖替代方法(如植入前基因诊断和体细胞编辑,如果它们安全且成功)之间的优先级。然而,禁止人类生殖系修饰需要相关利益攸关方,包括公众和立法者,重新进行讨论。