Bioethics Advisory Committee recommends tightly regulated human stem cell research and complete ban on reproductive cloning in Singapore

Singapore, 21 June 2002 Singapore's Bioethics Advisory Committee recommends a complete ban on human reproductive cloning and recommends that human stem cell research and therapeutic cloning be permitted under strict regulation. The regulatory framework should require the informed voluntary consent of donors, prohibit the commerce and sale of donated materials, especially surplus embryos and stipulate that no one shall be under a duty to participate in any manner of research on human stem cells to which he has a conscientious objection.

These were the key positions taken in the report, "Ethical, Legal and Social Issues in Human Stem Cell Research, Reproductive and Therapeutic Cloning" released by the Bioethics Advisory Committee ('BAC').

The BAC was appointed by Cabinet in December 2000 to examine the ethical, legal and social issues arising from biomedical research and development in Singapore, and to recommend policies to the Ministerial Committee for Life Sciences on those issues.

The Human Stem Cell Research ('HSR') Sub-Committee was formed under the BAC in February 2001 to specifically deal with the ethical, legal and social issues arising from human stem cell research, and to consider the related issues of reproductive and therapeutic cloning.

BAC Chairman, Professor Lim Pin, shares the fundamental approach of the BAC, "Our approach is to balance two key ethical commitments: to protect human life and the rights and welfare of the individual, and to advance human life by curing disease."

An extensive consultation process was undertaken that aimed to understand the concerns and sentiments of local interest groups and the general public. A website was set-up in August 2001 explaining the basic scientific and medical facts relating to HSR and inviting views from the public. In November 2001, a consultation paper was distributed to 39 religious and professional groups. 25 written responses were received and 3 dialogue sessions were held. In December 2001, a focus group discussion was jointly organised by the BAC and the Feedback Unit, Ministry of Community Development and Sports. 39 participants from all walks of life were present. International positions were examined, papers were commissioned from a panel of seven local experts, and inputs obtained from the BAC constituted International Panel of Experts.

"We have heard a wide range of views and opinions expressed," said Senior District Judge Richard Magnus. "This was no surprise given Singapore's diverse multi-religious, multi-cultural and multi-racial population. The report identifies the crux of the matter as arising from the ethics of deriving embryonic stem cells from human embryos for research purposes. The thoughtful written submissions by many groups and the feedback given through the dialogue sessions and our website reflect a wide spectrum of views. Some maintain that life with full personhood begins at conception, some say at 40 days, others believe that the embryo is only a group of cells until 4 months, and there are groups who are more focused on helping patients with severe incurable diseases."

After extensive research, careful consideration of community feedback and much deliberation, the BAC has come up with 11 key recommendations* on human stem cell research and reproductive and therapeutic cloning which it believes would lead to 'just' and 'sustainable' results. The results would be 'just', in that research with tremendous potential therapeutic benefits to mankind will proceed. The results would be 'sustainable', as such research has little biological or genetic impact on future generations, especially with the ban on reproductive cloning. (*Please refer to Annex 1 for a summary of the 11 recommendations)

"Whilst it is not possible to expect 100% agreement in a population that is so heterogeneous in terms of its cultural, racial and religious make-up, we have done everything possible to take into account all the views and concerns shared," Prof Lim Pin emphasizes. "Two key elements central to our recommendations are: strict regulation of research and provision for conscientious objection."

The report emphasized that it is crucial to set up a comprehensive and stringent regulatory framework. BAC recommends that a statutory authority with multidisciplinary membership including members of the public be set up to license, control and monitor all human stem cell research conducted in Singapore. Strict conditions should be attached to licences that are granted and the statutory authority should be empowered to conduct regular checks as well as to impose sanctions on those who fail to comply with the laws and regulations.

The report has been presented to the relevant ministries, and the government will decide on these recommendations later.

A copy of the report is available on the BAC website from 21 June 2002.

SUMMARY OF RECOMMENDATIONS

The BAC believes that the recommendations would lead to 'just' and 'sustainable' results. The results would be 'just', in that research with tremendous potential therapeutic benefits to mankind will proceed. The results would be 'sustainable' as such research has little biological or genetic impact on future generations, especially with the ban on the reproductive cloning.

Recommendation 1: Research involving the derivation and use of stem cells from adult tissues is permissible, subject to the informed consent of the tissue donor.

Recommendation 2: Research involving the derivation and use of stem cells from cadaveric foetal tissues is permissible, subject to the informed consent of the tissue donor. The decision to donate the cadaveric foetal tissue must be made independently from the decision to abort.

Recommendation 3: Research involving the derivation and use of ES cells is permissible only where there is strong scientific merit in, and potential medical benefit from, such research.

Recommendation 4: Where permitted, ES cells should be drawn from sources in the following order: (1) existing ES cell lines, originating from ES cells derived from embryos less than 14 days old; and (2) surplus human embryos created for fertility treatment less than 14 days old.

Recommendation 5: The creation of human embryos specifically for research can only be justified where (1) there is strong scientific merit in, and potential medical benefit from, such research; (2) no acceptable alternative exists, and (3) on a highly selective, case-by-case basis, with specific approval from the proposed statutory body.

Recommendation 6: For the derivation and use of ES cells, there must be informed consent from the donors of surplus human embryos, gametes or cells.

Recommendation 7: There should be a complete ban on the implantation of a human embryo created by the application of cloning technology into a womb, or any treatment of such a human embryo intended to result in its development into a viable infant.

Recommendation 8: There should be a statutory body to license, control and monitor all human stem cell research conducted in Singapore, together with a comprehensive legislative framework and guidelines.

Recommendation 9: In obtaining consent from donors of cells, gametes, tissues, foetal materials and embryos, the information provided to the donors must be comprehensive, and there must not be any inducements, coercion or undue influence.

Recommendation 10: The legislative and regulatory framework should prohibit the commerce and sale of donated materials, especially surplus embryos. Researchers should not be prohibited from gaining commercially from the products of research, as well as treatments and therapies developed from the donated materials.

Recommendation 11: The legislative framework should provide that no one shall be under a duty to participate in any manner of research on human stem cells, which would be authorised or permitted by the law, to which he has a conscientious objection.

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