Experiments that led to the first gene-edited babies: the ethical failings and the urgent need for better governance

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.

Ethics, Genetic Technologies and Equine Sports: The Prospect of Regulation of a Modified Therapeutic Use Exemption Policy

“…A recent conference presentation concerning the gene-editing of human embryos in order to prevent disease provoked public outcry and criticism from the academic community (Li et al 2019). Although Savulescu et al (2015) have argued in favour of allowing continuing research on gene editing of human embryos, others have advocated extreme caution (Baltimore et al 2015;Lanphier et al 2015).…”

Precision medicine in the era of CRISPR-Cas9: evidence from Bosnia and Herzegovina

“…The standards will then pave the way for an international framework under which scientists should perform research and clinical applications of gene editing, one, as the panel summarized in a report after its inaugural meeting, that will be scalable, sustainable, and focused to "work in parts of the world," countries like BH no question included, "where there is traditionally weaker regulation of scientific and clinical research and practice, and where genome editing may not yet be pursued with great intensity" (ibid). Going further, the scientific community has called for clear consensus, as well as enactment and enforcement of strict laws globally for the use of human genome editing in medical treatments (Li et al, 2019).…”

Precision medicine, agriculture, and genome editing: science and ethics

“…The research group cited the National Research Council report in justifying its project to individuals who are ethically concerned. On November 25, 2018, a Chinese researcher at the Southern University of Science and Technology in Shenzhen, China, He Jiankui, announced the creation of two genome‐edited babies, Lulu and Nana, engineered via CRISPR/Cas9 to disable the CCR5 gene, rendering them immune to HIV . The announcement was met with a cavalcade of criticism and condemnation from various national governments, including the Chinese and American governments, and a veritable panoply of prominent scientists, physicians, and ethicists.…”