Readying for the Emerging Moral Dilemmas in Genetic Modification of the Human Genome Sequence (Second Generation)
In a recent report, the International Commission on the Clinical Use of Human Germline Genome Editing (hHGE) has recommended caution in future uses of this groundbreaking technology. The report, published in September 2020, comes after the controversy surrounding Dr. He Jiankui's announcement that he had transferred edited human embryos into a uterus in November 2019.
The Commission's recommendations are based on the potential ethical concerns associated with hHGE, such as the unknown effects, the need for subsequent longitudinal follow-up of edited individuals and their offspring, potential therapeutic misconception, and the potential use for human enhancement or eugenics. The Commission also emphasises the importance of broad societal consensus and the empowerment of all stakeholders.
The report recommends that initial uses of hHGE should be limited to certain circumstances: for "serious monogenic diseases" that cause "severe morbidity or premature death", in which parents "have no option for having a genetically-related child without the disease" or "the expected proportion of unaffected embryos" would be less than 25%, and the parents have had one unsuccessful trial of Pre-implantation Genetic Diagnosis (PGD).
The Commission's definition of serious monogenetic disease is broad and includes conditions such as cardiomyopathy, various arrhythmias, and cancer susceptibilities. However, the specific disease examples used by the Commission are extremely rare and unlikely to be pursued.
The report also calls for an International Scientific Advisory Panel to assess the scientific safety and efficacy of hHGE, and for an international mechanism to address any concerns about deviations from these standards.
Robert Klitzman, MD, authored an editorial in the latest issue of the American Journal of Bioethics, expressing his views on the Commission's report. He notes that the report does not weigh financial costs against competing global health needs and does not address concerns about the best interests or rights of the unborn child, nor the implications of social inequities.
The Commission's recommendations reveal and underscore critical remaining challenges, such as the treatment effectiveness for certain diseases reducing the potential needs for hHGE, the rarity of the situations where hHGE could be justified, and the potential allocation of limited resources for hHGE.
The report also warns that the sanctioning of hHGE in rare circumstances could serve as a Trojan Horse, loophole, or slippery slope for other uses in less serious scenarios. The challenges raised by the Commission's Report concern the intricate balancing of competing ethical principles, not just issues of 'governance' per se.
The World Health Organization (WHO) created an Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing in response to Dr. He Jiankui's announcement. While the WHO Committee focuses on articulating broad principles and processes, the Commission's task involves considering societal and ethical issues.
ASRM and other countries' relevant professional organizations should stipulate that physicians and healthcare professionals should not be involved in any way in the care of patients using germline editing abroad. The Commission's Report provides valuable insights and guidelines, but multiple stakeholders will likely soon confront additional, complex dilemmas involving interplays of both science and ethics.
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