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Bulletin of Chinese Academy of Sciences (Chinese Version)

Keywords

in vitro human embryo research, ethical regulation, 14-day rule, Warnock Report

Document Type

Policy & Management Research

Abstract

Since it was proposed, in vitro human embryo research had been following the 14-day rule, which limited in vitro research on human embryos within 14 days after fertilization. With the advancement in embryo culturing technology, this ethical rule has been greatly challenged. In 2021, the International Society for Stem Cell Research (ISSCR) recommended a conditional extension of the existing time limit in ISSCR Guidelines for Stem Cell Research and Clinical Translation, hence the international scientific community has restarted the debate on the 14-day rule. This study systematically analyzed the historical background and controversies of the 14-day rule ethical regulation of human embryo research, as well as revisited the core ethical issues of the moral status, dignity, and legal status of human embryos as research subjects. It also comprehensively examined the attitudes of different stakeholders in responding to the relaxation of current regulations and raised policy agenda and suggestions in extending the time limit of human embryo research.

First page

1718

Last Page

1728

Language

Chinese

Publisher

Bulletin of Chinese Academy of Sciences

References

1 谭韬, 季维智. 灵长类生物医学前沿探索中的伦理思考. 科学与社会, 2021, 11(4): 1-11. Tan T, Ji W Z. Ethical and scientific issues concerning the frontier exploration of primate biomedicine. Science and Society, 2021, 11(4): 1-11. (in Chinese)

2 Shahbazi M N, Jedrusik A, Vuoristo S, et al. Self-organization of the human embryo in the absence of maternal tissues. Nature Cell Biology, 2016, 18(6): 700-708.

3 Deglincerti A, Croft G F, Pietila L N, et al. Self-organization of the in vitro attached human embryo. Nature, 2016, 533: 251-254.

4 Department of Health and Social Security. Report of the Committee of Inquiry into Human Fertilisation and Embryology. London: Her Majesty’s Stationery Office, 1984.

5 Hyun I, Wilkerson A, Johnston J. Embryology policy: Revisit the 14-day rule. Nature, 2016, 533: 169-171.

6 Zhou F, Wang R, Yuan P, et al. Reconstituting the transcriptome and DNA methylome landscapes of human implantation. Nature, 2019, 572: 660-664.

7 Xiang L F, Yin Y, Zheng Y, et al. A developmental landscape of 3D-cultured human pre-gastrulation embryos. Nature, 2020, 577: 537-542.

8 Zhai J L, Xu Y H, Wan H F, et al. Neurulation of the cynomolgus monkey embryo achieved from 3D blastocyst culture. Cell, 2023, 186(10): 2078-2091.

9 Niu Y Y, Sun N Q, Li C, et al. Dissecting primate early post-implantation development using long-term in vitro embryo culture. Science, 2019, 366: eaaw5754.

10 Ma H X, Zhai J L, Wan H F, et al.In vitro culture of cynomolgus monkey embryos beyond early gastrulation. Science, 2019, 366: eaax7890.

11 Gong Y D, Bai B, Sun N Q, et al. Ex utero monkey embryogenesis from blastocyst to early organogenesis. Cell, 2023, 186(10): 2092-2110.

12 Sagan A, Singer P. The moral status of stem cells. Metaphilosophy, 2007, 38(2-3): 264-284.

13 肇旭. 人类胚胎干细胞研究的伦理观分析. 伦理学研究, 2012, (1): 82-89. Zhao X. Analysis of ethical perspectives on human embryonic stem cell research. Studies in Ethics, 2012, (1): 82-89. (in Chinese)

14 Shannon T A, Wolter A B. Reflections on the moral status of the pre-embryo. Theological Studies, 1990, 51(4): 603-626.

15 Lockwood M. Warnock versus Powell (and Harradine): When does potentiality count?. Bioethics, 1988, 2(3): 187-213.

16 Sumner L W. Abortion and Moral Theory. Oxford: Princeton University Press, 2014, 285.

17 彭耀进, 吕建伟. 人类胚胎研究“14天规则”的挑战与出路. 自然辩证法通讯, 2022, 44(10): 77-86. Peng Y J, Lv W J. The challenges and solutions of the 14-day rule in human embryo research. Journal of Dialectics of Nature, 2022, 44(10): 77-86. (in Chinese)

18 Koch R. Conjoined twins and the biological account of personal identity. The Monist, 2006, 89(3): 351-370.

19 李亚明, 李建会. 人的尊严与人类增强. 哲学动态, 2019, (6): 98-108. Li Y M, Li J H. Human dignity and human enhancement. Philosophical Trends, 2019, (6): 98-108. (in Chinese)

20 Sacks J. The Dignity of Difference: How to Avoid the Clash of Civilizations. London: Continuum, 2004.

21 George R P. Human cloning and embryo research: The 2003 John J. Conley Lecture on medical ethics. Theoretical Medicine and Bioethics, 2004, 25(1): 3-20.

22 Resnik D B. Embryonic stem cell patents and human dignity. Health Care Analysis, 2007, 15(3): 211-222.

23 Zurriaráin R G. The dignity of the frozen human embryo. Revista de Medicina de la Universidad de Navarra, 2007, 51(1): 30-32.

24 Austriaco N P G. Debating embryonic dignity in a liberal society. Stem Cell Reviews, 2005, 1(4): 305-307.

25 Pinker S. The stupidity of dignity. New Republic, 2008, 28(5): 28-31.

26 Oduncu F S. Stem cell research in Germany: Ethics of healing vs. human dignity. Medicine, Health Care and Philosophy, 2003, 6(1): 5-16.

27 刘亚飞, 马小敏, 孙洪岩, 等. 论“基因编辑婴儿”对人的尊严的挑战. 医学与哲学, 2019, 40(11): 31-35. Liu Y F, Ma X M, Sun H Y, et al. Challenge of “gene-edited baby” on human dignity. Medicine & Philosophy, 2019, 40(11): 31-35. (in Chinese)

28 Kass L. Life, Liberty and the Defense of Dignity: The Challenge for Bioethics. New York: Encounter Books, 2002.

29 de Miguel Beriain I, Sanz B. Human dignity and gene editing: Additional support for Raposo’s arguments. Journal of Bioethical Inquiry, 2020, 17(2): 165-168.

30 Raposo V L. Gene editing, the mystic threat to human dignity. Journal of Bioethical Inquiry, 2019, 16(2): 249-257.

31 罗喜. 康德论人的尊严——兼论尊严的可丧失性问题. 当代中国价值观研究, 2020, 5(1): 24-35.Luo X. Kant on human dignity—On the issue of the loss of the dignity. Chinese Journal of Contemporary Values, 2020, 5(1): 24-35. (in Chinese)

32 Tyser R C V, Mahammadov E, Nakanoh S, et al. Single-cell transcriptomic characterization of a gastrulating human embryo. Nature, 2021, 600(7888): 285-289.

33 李佳伦. 英国法对人体胚胎的民事法律地位的争议. 人民司法, 2014, (13): 107-111.Li J L. Controversy over the civil legal status of human embryos under English law. People’s Judicature, 2014, (13): 107-111. (in Chinese)

34 徐海燕. 论体外早期人类胚胎的法律地位及处分权. 法学论坛, 2014, 29(4): 146-152.Xu H Y. The legal status of early embryos and the right of the disposition of frozen embryos. Legal Forum, 2014, 29(4): 146-152. (in Chinese)

35 张善斌, 李雅男. 人类胚胎的法律地位及胚胎立法的制度构建. 科技与法律, 2014, (2): 276-295.Zhang S B, Li Y N. The legal status of human embryo and recommendations for China’s legislative structure. Science Technology and Law, 2014, (2): 276-295. (in Chinese)

36 Hurlbut J B, Hyun I, Levine A D, et al. Revisiting the Warnock rule. Nature Biotechnology, 2017, 35(11): 1029-1042.

37 Chan S. How and why to replace the 14-day rule. Current Stem Cell Reports, 2018, 4(3): 228-234.

38 Chan S. How to rethink the fourteen-day rule. Hastings Center Report, 2017, 47(3): 5-6.

39 Warnock M. Should the 14-day limit on human embryo research be extended?. BioNews, 2017-01-09(883).

40 Greely H T. The 14-day embryo rule: A modest proposal. Houston Journal of Health Law & Policy, 2022, 22: 147.

41 Leida A. Almost half of the UK public support extending the 14-day rule. BioNews, 2017-01-23(885).

42 Peng Y J, Lv J W, Xiao Z Y, et al. A framework for the responsible reform of the 14-day rule in human embryo research. Protein & Cell, 2022, 13(8): 552-558.

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