Bioethics Advisory Committee consults on ethical, legal, and social issues arising from human nuclear genome editing

25 June 2024

The Bioethics Advisory Committee (“BAC”) is, between 6 June 2024 to 16 August 2024, conducting a public consultation on ethical, legal, and social issues arising from using human nuclear genome editing (“HNGE”) in biomedical research, clinical research, and healthcare.

By way of background, recent advances in HNGE technologies have led to the discovery of more precise tools that hold great promise in advancing human biomedical research and clinical translation, with the potential to improve human health. While HNGE technologies have the potential to confer resistance to diseases and enhance traits in the future, they also raise ethical issues such as unintended consequences and long-term effects on individuals and future generations, resulting in social inequalities, and other issues on consent.

BAC will engage with relevant stakeholders, including representatives from various academic, research and healthcare institutions, clinical ethics committees, institutional review boards, and industry partners through focus group discussions in July and August 2024. The feedback received will assist BAC in developing recommendations in the final advisory report to provide guidance on the ethical use of HNGE applications in human biomedical research, clinical research, and healthcare.

Public consultation

BAC has published a consultation paper on “Ethical, Legal, and Social Issues arising from Human Nuclear Genome Editing” to discuss the ethical issues arising from the use of HNGE technologies in biomedical and clinical research and other potential clinical applications. Other topics discussed in the consultation paper include mosaicism, off-target effects, long-term safety, equitable access, the broad effect of genetic enhancement on society, and how the HNGE governance framework can be implemented in Singapore. Ethical considerations raised for feedback in the consultation paper include:

  • How should researchers and clinicians balance the potential benefits of gene editing technologies against the risks associated with mosaicism and off-target effects?
  • How should researchers, research institutions, and clinicians ensure favourable risk-benefit ratio is achieved for patients or participants undergoing clinical trials or clinical interventions involving non-heritable gene editing?
  • Should clinical applications of heritable gene editing be allowed, given the difficulty in predicting the long-term consequences of such applications on future generations?
  • What can regulatory authorities do to ensure that embryo or oocyte donors are not receiving any inducement but fairly reciprocated for their contributions to gene editing research?
  • What are the ethical considerations in ensuring equitable access to gene editing technologies?
  • What can be done to ensure that gene editing technologies are used responsibly and ethically?

Building upon previous BAC reports and recommendations and referencing relevant legislation/Acts such as the Human Biomedical Research Act 2015, the Human Cloning and Other Prohibited Practices Act 2004, and the Healthcare Services Act 2020, the consultation paper covers the ethical principles to guide the ethical use of HNGE applications in human biomedical research, clinical research, and clinical translation, such as respect for persons, solidarity, justice, proportionality, sustainability, and other ethical considerations including inclusivity, transparency, and responsible stewardship of science.

The consultation paper is an adapted version of the final advisory report. A summary of the main comments/feedback received, together with the final report and recommendations will be published on the BAC website and REACH portal in the first half of 2025.

Reference materials

The following materials are available on the REACH website www.reach.gov.sg: