Abstract: The rapid developments of science and technology in China over recent decades, particularly in biomedical research, have brought forward serious challenges regarding ethical governance. Recently, Jian-kui HE, a Chinese scientist, claimed to have “created” the first gene-edited babies, designed to be naturally immune to the human immunodeficiency virus (HIV). The news immediately triggered widespread criticism, denouncement, and debate over the scientific and ethical legitimacy of HE’s genetic experiments. China’s guidelines and regulations have banned germline genome editing on human embryos for clinical use because of scientific and ethical concerns, in accordance with the international consensus. HE’s human experimentation has not only violated these Chinese regulations, but also breached other ethical and regulatory norms. These include questionable scientific value, unreasonable risk-benefit ratio, illegitimate ethics review, invalid informed consent, and regulatory misconduct. This series of ethical failings of HE and his team reveal the institutional failure of the current ethics governance system which largely depends on scientist’s self-regulation. The incident highlights the need for urgent improvement of ethics governance at all levels, the enforcement of technical and ethical guidelines, and the establishment of laws relating to such bioethical issues.

[1]Allers K, Hütter G, Hofmann J, et al., 2011. Evidence for the cure of HIV infection by CCR5Δ32/Δ32 stem cell transplantation. Blood, 117(10):2791-2799.

[2]Bauer G, Anderson JS, 2014. Gene Therapy for HIV. Springer, New York, NY.

[3]Baumann M, 2016. CRISPR/Cas9 genome editing—new and old ethical issues arising from a revolutionary technology. Nanoethics, 10(2):139-159.

[4]de Miguel Beriain I, del Cano AMM, 2018. Chapter 12 Gene editing in human embryos. A comment on the ethical issues involved. In: Soniewicka M (Ed.), The Ethics of Reproductive Genetics: Between Utility, Principles, and Virtues. Springer, Cham, p.173-183.

[5]Dunbar CE, High KA, Joung JK, et al., 2018. Gene therapy comes of age. Science, 359(6372):eaan4672.

[6]Kim D, Bae S, Park J, et al., 2015. Digenome-seq: genome-wide profiling of CRISPR-Cas9 off-target effects in human cells. Nat Methods, 12(3):237-243.

[7]Li YJ, Han Y, Xie J, et al., 2014. CRF01_AE subtype is associated with X4 tropism and fast HIV progression in Chinese patients infected through sexual transmission. AIDS, 28(4):521-530.

[8]Liang PP, Xu YW, Zhang XY, et al., 2015. CRISPR/Cas9-mediated gene editing in human tripronuclear zygotes. Protein Cell, 6(5):363-372.

[9]Liu SJ, Kong CJ, Wu J, et al., 2012. Effect of CCR5-Δ32 heterozygosity on HIV-1 susceptibility: a meta-analysis. PLoS ONE, 7(4):e35020.

[10]Nie JB, Fitzgerald RP, 2016. Connecting the east and the west, the local and the universal: the methodological elements of a transcultural approach to bioethics. Kennedy Inst Ethics J, 26(3):219-247.

[11]Qiu RZ, 2016. Debating ethical issues in genome editing technology. Asian Bioeth Rev, 8(4):307-326.

[12]SinaTech, 2018. The first human immunodeficiency virus (HIV) immune gene-edited babies were born in China. https://tech.sina.cn/d/bk/2018-11-26/detail-ihmutuec3688779.d.html [Accessed on Nov. 26, 2018] (in Chinese).

[13]Tebas P, Stein D, Tang WW, et al., 2014. Gene editing of CCR5 in autologous CD4 T cells of persons infected with HIV. N Engl J Med, 370(10):901-910.

[14]Wang C, Zhai XM, Zhang XQ, et al., 2018. Gene-edited babies: Chinese academy of medical sciences’ response and action. Lancet, in press.

[15]Wu YX, Liang D, Wang YH, et al., 2013. Correction of a genetic disease in mouse via use of CRISPR-Cas9. Cell Stem Cell, 13(6):659-662.

[16]Zhang XQ, 2016. Risk-benefit analysis of CRISPR-Cas germline editing clinical research on human embryos and its ethical governance. Sci Soc, 6(3):12-21 (in Chinese).