Stem cell researchers in Singapore can anticipate a comprehensive set of local bioethical guidelines and a regulated research and development framework soon. Last week, Singapore's Bioethics Advisory Committee (BAC) came out with 11 key recommendations involving the licensing, control, and monitoring of all human stem cell research in the city-state. BAC's recommendations (see sidebar), which include establishing a statutory authority with multidisciplinary membership including members of the public, were made after extensive consultations with a panel of international experts, local community and religious groups, and the general public.

BAC, an independent entity that comprises government officials, community leaders, media representatives, and medical experts, was set up in 2000 to study the ethical, legal, and social issues brought about by the rapid development in biomedical research in Singapore. In February 2001, BAC formed its Human Stem Cell Research (HSR) subcommittee to deal specifically with issues arising from human stem cell research and to consider related issues of reproductive and therapeutic cloning.

The Bioethics Advisory Committee's Recommendations

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

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 of the decision to abort.

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

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 less than 14 days old that were created for fertility treatment.

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.

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

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.

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.

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.

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.

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 authorized or permitted by the law, to which he has a conscientious objection.

Stem cell scientists in Singapore--most notably, the group at ES Cell International, one of the world's top stem cell suppliers--have adopted the internationally recognized National Institutes of Health Guidelines. Nevertheless, a comprehensive local legislative and regulatory framework is generally deemed essential to ensure proper research conduct and increase confidence in local biomedical research and development. "If we aspire to be a biomedical hub, we need to do it in a way that is morally responsible," says Lim Pin, who chairs BAC.

BAC's recommendations with respect to human stem cell research are comprehensive. "Our approach was 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," explains Lim. "Two key elements central to our recommendations are strict regulation of research and provision of conscientious objection," he emphasizes.

"We believe we have taken into account all points of view and concerns to create a framework that allows important medical research to continue while maintaining respect for the embryo," says Lim. Stressing the point further, Senior District Judge Richard Magnus, the head of BAC's HSR subcommittee, notes that embryos would be accorded "a special status." For that very reason, Magnus says, "various constraints and strict rules have been built in to provide a very measured way of dealing with stem cell research."

BAC recommends that research on human embryonic stem cells should be allowed only where there is strong scientific merit in, and potential medical benefit from, such research. In these instances, the committee says, the use of existing embryonic cell lines derived from embryos fewer than 14 days old should be considered before resorting to the use of cells taken from surplus in vitro fertilization embryos fewer than 14 days old. The committee says the 14-day mark is an appropriate limit as the cells of the embryo are not yet differentiated into tissues, in that there is no organized development.

The creation of embryos specifically for research might be allowed on a "highly selective case-by-case basis where no acceptable alternative exists," a standard that will be subjected to "approval from the proposed statutory board." BAC, however, calls for an outright ban on human reproductive cloning and affirms that scientists caught doing so would face the full force of the law, although final details of penalties for offenders have not been spelled out.

In addition, BAC also recommends that informed consent be sought from all cell and tissue donors and that the buying and selling of donated materials, such as surplus embryos, be prohibited. With respect to the latter, it states, "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." Similarly, tissue or surplus embryos from fertility treatment donated for research must be an "absolute gift," and anyone caught selling or buying donated materials, or coercing or inducing others to donate, would face tough legal sanctions.

However, BAC maintains that "researchers should not be prohibited from gaining commercially from the products of research, as well as treatments and therapies developed from the donated materials." Explaining this recommendation in more detail, Lim adds, "Scientists put time, work, money, [and] commitment into developing the cures and therapies from the basic material. So there must be a reward system in place for these scientists, or else it would be difficult to participate in this kind of work."

The committee believes that its recommendations are both "just" and "sustainable." They are just in the sense that they allow research with potential therapeutic benefit to proceed, and sustainable in that the proposed ban on reproductive cloning will ensure that such research has little biological or genetic impact on future generations.

If the recommendations are implemented, as appears likely, scientists seeking to carry out human stem cell research in Singapore will have to go through a stringent procedure to obtain appropriate licenses for their work. They will also have to adhere to strict regulatory guidelines and expect their research to be subjected to close scrutiny by the authorities.

Onerous though it might be, the added effort will likely contribute to greater good. The BAC guidelines should reassure the public and ensure that scientists work within the confines of ethically acceptable limits. The guidelines "will enhance our image internationally and make research work done here more acceptable," says Tan Chorh Chuan, director of medical services at the Ministry of Health.