Skip to main content
SpringerLink
Log in

Ethical issues in human germline gene editing: a perspective from China

  • Original Article
  • Published:
Monash Bioethics Review Aims and scope Submit manuscript

Abstract

The ethical issues associated with germline gene modification and embryo research are some of the most contentious in current international science policy debates. In this paper, we argue that new genetic techniques, such as CRISPR, demonstrate that there is an urgent need for China to develop its own regulatory and ethical framework governing new developments in genetic and embryo research. While China has in place a regulatory framework, it needs to be strengthened to include better compliance oversight and explicit criteria for how different types of research should be reviewed by regulatory authorities. We also document a variety of opinions about the new technologies among the public, scholars, and policy makers. China needs to develop its own regulations in coordination with other countries; but it is unlikely that an international consensus will be achieved in this area, given the existing differences in regulations between countries. We should aim at harmonization, not necessarily complete consensus, and the perspective from China is vital when international norms are developed and harmonized. Chinese policy makers and researchers need to be aware of the international discussions, at the same time as the international community is aware of, and accommodates, Chinese positions on important policy options.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

Abbreviations

CRISPR:

Clustered regularly interspaced short palindromic repeats

HFEA:

Human fertilization & embryology authority

NHFPC:

National health and family planning commission

MOST:

Ministry of science and technology

NIH:

National Institutes of Health

ISSCR:

International society for stem cell research

References

  • Aach, J., et al. Addressing the ethical issues raised by synthetic human entities with embryo-like features. Elife. https://www.ncbi.nlm.nih.gov/pubmed/28494856. Accessed 21 Mar 2017.

  • Ai, L. 2016. Thinking of gene editing technology ethical controversy. Science and Society 6 (3): 7.

    Google Scholar 

  • Baltimore, D. 2015. Biotechnology. A prudent path forward for genomic engineering and germline gene modification. Science 348 (6230): 36–38.

    Article  Google Scholar 

  • Belluck, P. 2017. In breakthrough, scientists edit a dangerous mutation from genes in human embryos, in New York Times. https://www.nytimes.com/2017/08/02/science/gene-editing-human-embryos.html.

  • Callaway, E. 2016a. Gene-editing research in human embryos gains momentum. Nature 532 (7599): 289–290.

    Article  Google Scholar 

  • Callaway, E. 2016b. UK scientists gain licence to edit genes in human embryos. Nature 530 (7588): 18.

    Article  Google Scholar 

  • Carver, J., et al. 2003. An in vitro model for stromal invasion during implantation of the human blastocyst. Human Reproduction 18 (2): 283–290.

    Article  Google Scholar 

  • Chen, Y., et al. 2003. Embryonic stem cells generated by nuclear transfer of human somatic nuclei into rabbit oocytes (In Chinese). Cell Research 13 (4): 251–263.

    Article  Google Scholar 

  • China’s Ministry of Health, Ministry of Finance, and ministry of Agriculture. Decision on establishing New Rural Cooperative Medical Insurance Scheme. 2003. http://www.gov.cn/zwgk/2005-08/12/content_21850.htm.

  • China targets reproductive technology abuse. http://www.chinadaily.com.cn/china/2013-02/05/content_16204479.htm. Accessed 2 Feb 2013.

  • CNN: Chinese scientist claims world’s first gene-edited babies, amid denial from hospital and international outcry. https://edition.cnn.com/2018/11/26/health/china-crispr-gene-editing-twin-babies-first-intl/index.html. Accessed 27 Nov 2018.

  • Connor, S. 2017. First human embryos edited in U.S. https://www.technologyreview.com/s/608350/first-human-embryos-edited-in-us/. Accessed 1 Aug 2017.

  • Cyranoski, D., and S. Reardon. 2015. Embryo editing sparks epic debate. Nature 520 (7549): 593–594.

    Article  Google Scholar 

  • Daley, G.Q., et al. 2016. Setting global standards for stem cell research and clinical translation: The 2016 ISSCR guidelines. Stem Cell Reports 6 (6): 787–797.

    Article  Google Scholar 

  • Deglincerti, A., et al. 2016. Self-organization of the in vitro attached human embryo. Nature 533 (7602): 251–254.

    Article  Google Scholar 

  • Ethical guiding principles for ethical review of clinical trials for drugs (In Chinese). 2010. Beijing: China Food and Drug Administration.

  • Ethical guiding principles for human embryonic stem cell research (In Chinese). 2003. Beijing: Ministry of Science and Technology & Ministry of Health.

  • Evitt, N.H., S. Mascharak, and R.B. Altman. 2015. Human germline CRISPR-cas modification: Toward a regulatory framework. American Journal of Bioethics 15 (12): 25–29.

    Article  Google Scholar 

  • Gaskell, G., et al. 2017. Public views on gene editing and its uses. Nature Biotechnology 35 (11): 1021–1023.

    Article  Google Scholar 

  • Han, Z. 2009. Research on the equity of health care between urban and rural in China (In Chineses). Beijing: China Social Sciences Publishing House.

    Google Scholar 

  • Han, B., et al. 2007. Attitudes of deaf youths towards genetic testing for hereditary deafness (In Chinese). Chinese Journal of Otology 5 (4): 4.

    Google Scholar 

  • He, X. 2015. Barrier of organ donation (In Chinese). http://opinion.people.com.cn/n/2015/0126/c159301-26452539.html. Accessed 17 May 2017.

  • HFEA. 2016. HFEA approves licence application to use gene editing in research. http://www.hfea.gov.uk/10187.html. Accessed 17 May 2017.

  • Hou, J., F. Guo, and L. Guo. 2012. Analysis and solution to the cognition of deaf children parents on gene tests (In Chinese). Chinese Journal of Otology 10 (1): 2.

    Google Scholar 

  • International summit on human gene editing: A global discussion, in international summit on human gene editing: A global discussion, S. Olson, Editor. 2016. Washington (DC): The National Academies.

  • Isasi, R., E. Kleiderman, and B.M. Knoppers. 2016. Genetic technology regulation. Editing policy to fit the genome? Science 351 (6271): 337–339.

    Article  Google Scholar 

  • ISSCR. 2016. Guidelines for stem cell research and clinical translation. The International Society for Stem Cell Research.

  • Kang, X., et al. 2016. Introducing precise genetic modifications into human 3PN embryos by CRISPR/Cas-mediated genome editing. Journal of Assisted Reproduction and Genetics 33 (5): 581–588.

    Article  Google Scholar 

  • Kiatpongsan, S. and D. Sipp. 2009. Medicine. Monitoring and regulating offshore stem cell clinics. Science 323(5921):1564–1565.

  • Kolata, G. 2016. Building a better human with science? The public says, no thanks. https://www.nytimes.com/2016/07/27/upshot/building-a-better-human-with-science-the-public-saysno-thanks.html. Accessed 23 Dec 2018.

  • Li, J., and T. Wang. 2016. The ethical debate on the research of gene-editing of human embryos (In Chinese). Science and Society 6 (3): 10.

    Google Scholar 

  • Li, J. and X. Zhang. 2016. Study on the ethical problems of embryonic genetic designing (In Chinese). Medicine & Philosophy 37 (13): 6.

    Google Scholar 

  • Liang, P., et al. 2015. CRISPR/Cas9-mediated gene editing in human tripronuclear zygotes. Protein Cell 6 (5): 363–372.

    Article  Google Scholar 

  • Liu, Z., et al. 2018. Cloning of macaque monkeys by somatic cell nuclear transfer. Cell 172(4):881–887 e7.

  • Ma, H., et al. 2017. Correction of a pathogenic gene mutation in human embryos. Nature 548 (7668): 413–419.

    Article  Google Scholar 

  • Notice of the ministry of health on amending the technical specifications, basic standards and ethical principles related to human assisted reproductive technology and human sperm bank. 2003. http://www.moh.gov.cn/mohbgt/pw10303/200804/18593.shtml.

  • Nuffield Council on Bioethics. Council to consider the’14 day rule’ in embryo research. 2016. http://nuffieldbioethics.org/news/2016/council-14-day-rule-embryo-research. Accessed 18 May 2017.

  • Qiu, R. 2015. Dialogue between science and ethics on human embryo gene editing (In Chinese). Jiankang Bao. http://www.jkb.com.cn/medicalHumanities/2015/0508/368639.html. Accessed 08 May 2017.

  • Qiu, R. 2016. Research and application of gene editing technologies: An ethical perspective (In Chinese). Medicine & Philosophy 37 (13): 7.

    Google Scholar 

  • Qiu, R. and D. Zhang. Humanistic inspirations of nuremburg code for reproductive ethics (In Chinese). Jian Kang Bao 2016 September 23. http://www.jkb.com.cn/medicalHumanities/2016/0923/395633.html.

  • Qiu, X., et al. 2005. Investigation and discussion on the ethical issues of therapeutic cloning and human embryo administrative (In Chinese). Chinese Medical Ethics 18 (6): 5.

    Google Scholar 

  • Qiu, X., et al. 2010. Reinvestigation on ethical issues in stem cell study and clinical use: Results and recommendations (In Chinese). Medicine & Philosophy 31 (3): 4.

    Google Scholar 

  • Reardon, S. 2015. NIH reiterates ban on editing human embryo DNA. Nature. https://www.nature.com/news/nih-reiterates-ban-on-editing-human-embryo-dna-1.17452.

  • Regulations on ethical reviews of biomedical research involving human beings (In Chinese). 2016. Beijing: National Health and Family Planning Commission.

  • Regulations on ethical reviews of biomedical research involving human beings (trial implementation) (In Chinese). 2007. Beijing: Ministry of Health.

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

    Article  Google Scholar 

  • Sipp, D., and D. Pei. 2016. Bioethics in China: No wild east. Nature 534 (7608): 465–467.

    Article  Google Scholar 

  • Statement from the organizing committee on reported human embryo genome editing. http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=11282018b. 29 Nov 2018.

  • Tang, L., et al. 2017. CRISPR/Cas9-mediated gene editing in human zygotes using Cas9 protein. Molecular Genetics and Genomics 292 (3): 525–533.

    Article  Google Scholar 

  • Tatlow, D.K. 2015. A scientific ethical divide between China and the West, in New York Times.

  • The national health and family planning commission held a picturephone meeting on normative management of medical institutions and medical technology management (In Chinese). 2016. http://www.nhfpc.gov.cn/yzygj/s3586/201605/d56286761ce642519b8ac3e9c8c8b695.shtml. Accessed 18 July 2017.

  • Wang, H. 2016. Ethical Inquiries about CRISPR/Cas9-mediated gene editing in human tripronuclear zygotes (In Chinese). Medicine & Philosophy 37 (13): 4.

    Google Scholar 

  • Wang, C., et al. 2018. Gene edited babies: Chinese Academy of Medical Sciences’ response and action. Lancet.

  • Weisberg, S.M., D. Badgio, and A. Chatterjee. 2017. A CRISPR new world: Attitudes in the public toward innovations in human genetic modification. Front Public Health 5: 117.

    Article  Google Scholar 

  • Xunzi, B.C. The theory of rite (In Chinese). Ancient Chinese text.

  • Zhang, S. 2016. After the case of Wei Zexi, whether “the fourth way” of defencing cancer is blocked? (In Chinese). http://www.chinanews.com/jk/2016/07-20/7946392.shtml. Accessed 17 May 2017.

  • Zhang, X. 2016b. Risk-benefit analysis of CRISPR-Cas germline editing clinical research on human embryos and its ethical governance (In Chinese). Science and Society 6 (3): 10.

    Google Scholar 

  • Zhang, L. and  Y.Z. Zhang. 2012. Acceptance of prenatal screening for FMR1 mutation in Chinese female population (In Chinese). Chinese Journal of Birth Health & Heredity 20 (5): 3.

    Google Scholar 

  • Zhang, L., et al. 2018. Open letter from Chinese HIV professionals on human genome editing. Lancet. https://doi.org/10.1016/S0140-6736(18)33082-4.

    Article  Google Scholar 

Download references

Acknowledgements

Thanks go to Dr David Wendler and Dr Xiaomei Zhai for their careful and insightful comments.

Funding

National Social Sciences Fund (16CZX063).

Author information

Authors and Affiliations

  1. Department of Social Sciences and Humanities/Center for Bioethics, Chinese Academy of Medical Sciences & Peking Union Medical College, Dong Dan San Tiao #5, Dongcheng District, Beijing, 100730, China

    Di Zhang

  2. Department of Philosophy, University of Bergen, Sydnesplassen 12-13, 5020, Bergen, Norway

    Reidar K. Lie

Authors
  1. Di Zhang
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Reidar K. Lie
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

Di Zhang developed the original idea and is the main contributor to the content of this manuscript. Reidar K. Lie has made substantial contributions to the conception of this work and to revision of its content. All authors read and approved the final paper.

Corresponding author

Correspondence to Reidar K. Lie.

Ethics declarations

Competing interests

The authors declare that they have no conflict of interest.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Zhang, D., Lie, R.K. Ethical issues in human germline gene editing: a perspective from China. Monash Bioeth. Rev. 36, 23–35 (2018). https://doi.org/10.1007/s40592-018-0091-0

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40592-018-0091-0

Keywords

Search

Navigation