Ethical, Legal, and Social Issues in Human Nuclear Genome Editing

16 APR 2024

PUBLIC CONSULTATION ON ETHICAL, LEGAL, AND SOCIAL ISSUES IN HUMAN NUCLEAR GENOME EDITING

1\. The Bioethics Advisory Committee (BAC) will conduct a public consultation to seek views and feedback on the ethical, legal, and social issues in Human Nuclear Genome Editing (HNGE). The online consultation will be conducted from 3 June 2024 to 31 July 2024 and can be accessed from <a href="https://www.bioethics-singapore.gov.sg/files/publications/consultation-papers/big-data-and-ai.pdf/">here</a>or <a href="https://go.gov.sg/feedback-bdai/">REACH Portal</a>.

Ethical Challenges of Human Nuclear Genome Editing

2\. .

Aim of Consultation

3\. Recognising these ethical challenges, the BAC has developed a public consultation paper ‘Ethical, legal, and social issues in Human Nuclear Genome Editing’ to discuss the ethical principles underpinning the use of HNGE and selected use-cases in clinical research, such as respect for persons, solidarity<sup>[1]</sup>, justice, proportionality<sup>[2]</sup> and sustainability. Other ethical considerations are also discussed, including integrity, transparency, accountability, consistency and stakeholder engagement. The paper is intended to guide academics, researchers, healthcare professionals, Clinical Ethics Committees (CECs) and Institutional Review Boards (IRBs) on the ethical use of HNGE. Other clinical or healthcare aspects will not be covered within the scope of the paper.

4\. The report builds upon previous BAC reports and recommendations and references relevant legislations such as the Personal Data Protection Act (2012) and the Human Biomedical Research Act (2015), and complements other big data and AI reports and ethical guidelines in Singapore to provide guidance to decision-makers who work with big data in health and research, codify good practice and support the safe growth of AI in biomedical and healthcare research.

5\. The views of the public, academic, research, and healthcare institutions, CECs, IRBs, professional bodies and societies, and other interested organisations will assist the BAC in developing its recommendations.

Scope of Consultation

6\. The public consultation paper covers ethical issues arising from the use of big data and AI in human biomedical research, such as responsible data usage, data ownership, custodianship, and stewardship, data privacy, accessibility and security, data anonymisation and other ethical considerations and issues specific to AI. Please refer to Annex A for the outline of key ethical questions and issues raised in the consultation paper.

Period of Consultation

7\. The public consultation will last for a period of two months from 3 June 2024 to 31 July 2024. All comments should be sent in by 31 July 2024. Any comments received after 31 July 2024 will not be considered.

Feedback Channels

8\. The public consultation paper can be accessed from the <a href=" https://www.bioethics-singapore.gov.sg/">BACwebsite</a> or <a href="https://go.gov.sg/feedback-bdai/">REACH Portal</a>. Members of the public are invited to provide feedback on the issues discussed in the public consultation paper through the following channels:

a. By email: <br> &lt;[bioethics\_singapore@moh.gov.sg](mailto: bioethics_singapore@moh.gov.sg)&gt;

b. By post:<br>

Biomedical Ethics Coordinating Office<br>

1 Maritime Square<br>

#09-66 HarbourFront Centre<br>

Singapore 099253<br>

c. By online feedback form:<br>

9\. There will be focus group discussions conducted physically or virtually via Zoom in June/July 2024. The BAC will invite representatives from various academic, research and healthcare institutions, CECs, IRBs, professional bodies and societies, as well as industry partners to participate in these sessions.

Summary of Response

10\. 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 end 2024.

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ANNEX A

[Invitation To Comment] Public Consultation Paper: Ethical, Legal, and Social Issues in Human Nuclear Genome Editing.

a.

1\.

Ethical Considerations:

i.

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### Footnotes

<br><sup>[1]</sup>

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[Press Release (PDF)](/files/publications/press-releases/bac-bdai-press-release.pdf)