Xue Yang, Shang Lijun
Law School, Tianjin University, Tianjin, China.
Center for Biosafety Research and Strategy, Tianjin University, Tianjin, China.
Front Cell Dev Biol. 2022 Oct 24;10:1016988. doi: 10.3389/fcell.2022.1016988. eCollection 2022.
The ISSCR recently released new guidelines that relaxed the 14-day rule taking away the tough barrier, and this has rekindled relevant ethical controversies and posed a fresh set of challenges to each nation's legislations and policies directly or indirectly. To understand its broad implications and the variation and impact of China's relevant national policies, we reviewed and evaluated Chinese laws, administrative regulations, departmental rules, and normative documents on fundamental and preclinical research involving human embryos from 1985 to 2022 in this paper. We have historically examined whether these regulations, including a 14-day rule, had restrictions on human embryo research, and whether and how these policies affected human embryo and embryoid research in China. We also discussed and assessed the backdrop in which China has endeavored to handle such as the need for expanding debates among justice practice, academia, and the public, and the shifting external environment influenced by fast-developing science and technology and people's culture and religions. In general, Chinese society commonly opposes giving embryos or fetuses the legal status of humans, presumably due to the Chinese public not seeming to have any strong religious beliefs regarding the embryo. On this basis, they do not strongly oppose the potential expansion of the 14-day rule. After the guidelines to strengthen governance over ethics in science, and technology were released by the Chinese government in 2022, Chinese policymakers have incorporated bioethics into the national strategic goals using a "People-Centered" approach to develop and promote an ecological civilization. Specifically, China follows the "precautionary principle" based on ethical priority as it believes that if scientific research carries any potential technological and moral risks on which no social ethical consensus has been attained, there would be a need to impose oversight for prevention and precaution. At the same time, China has adopted a hybrid legislative model of legislation and ethical regulations with criminal, civil and administrative sanctions and a 14-day limit specified within its national hESCs guidelines. This would certainly be a useful example for other countries to use when considering the possibility of developing a comprehensive, credible and sustainable regulatory framework.
国际干细胞研究学会（ISSCR）最近发布了新指南，放宽了14天规则，消除了这一严格限制，这再次引发了相关伦理争议，并直接或间接地给各国的立法和政策带来了一系列新挑战。为了解其广泛影响以及中国相关国家政策的变化和影响，我们在本文中回顾并评估了1985年至2022年期间中国有关涉及人类胚胎的基础研究和临床前研究的法律、行政法规、部门规章及规范性文件。我们从历史角度审视了这些法规（包括14天规则）是否对人类胚胎研究有限制，以及这些政策是否以及如何影响了中国的人类胚胎和类胚胎研究。我们还讨论并评估了中国努力应对此类情况的背景，例如在司法实践、学术界和公众之间扩大辩论的必要性，以及受快速发展的科学技术以及人们的文化和宗教影响而不断变化的外部环境。总体而言，中国社会普遍反对赋予胚胎或胎儿人类的法律地位，这大概是因为中国公众似乎对胚胎没有强烈的宗教信仰。在此基础上，他们并不强烈反对14天规则的潜在扩展。2022年中国政府发布加强科技伦理治理的指南后，中国政策制定者以“以人为本”的方式将生物伦理纳入国家战略目标，以发展和促进生态文明。具体而言，中国遵循基于伦理优先的“预防原则”，因为它认为，如果科学研究存在任何潜在的技术和道德风险，且尚未达成社会伦理共识，那么就需要进行监督以预防和防范。同时，中国采用了立法与伦理规范相结合的混合立法模式，包括刑事、民事和行政制裁，并在其国家人类胚胎干细胞指南中规定了14天的期限。这无疑将成为其他国家在考虑制定全面、可信和可持续监管框架时可借鉴的有益范例。
