Monica Amarelo
mamarelo@aaas.org
202-326-6431

American Assocation for the Advancement of Science

Tracking every egg? – AAAS report lists practical options for regulating human cloning

Regulating Human Cloning outlines the results of a recent workshop that brought together scientists, policymakers and others. Participants explored options for regulating human research cloning to support medical advances--while preventing efforts to clone people, or "reproductive" cloning.

"AAAS, along with most of the world's mainstream scientists, endorses a legally enforceable ban on any efforts to clone a baby," said Alan I. Leshner, the Association's chief executive officer and executive publisher of Science. "Our fear of reproductive cloning is understandable and appropriate. But, we must not allow those concerns to block medical advances that may someday be achieved through other kinds of research that involve cloned cells. The recent AAAS workshop was an important first step toward identifying options to ensure that research cloning occurs in the safest, most responsible manner possible."

The American Association for the Advancement of Science (AAAS) workshop was intended to stimulate dialogue among those with diverse views. It therefore steers clear of making consensus recommendations, and instead lists options.

For example, to support responsible research cloning, one workshop group proposed that:

• Research cloning methods should be approved only following animal studies;
• All donors must provide informed consent;
• The cloned embryo must not be allowed to develop beyond 14 days;
• Regulations should protect privacy and confidentiality of data; and
• A system must be established to track and monitor the research products.

To prevent human clones, one option discussed by attendees would ensure that:

• The transfer of a cloned embryo into a uterus would be illegal;
• Facilities conducting research cloning would not house fertility labs;
• All products of research cloning, and their outcome, would be recorded; and
• Shipment or transport of cloned embryos would not be allowed (though the transport of products such as stem cells would be acceptable).

Options for regulatory structures evaluated by AAAS workshop participants included:

• "RAC-like Body" – The Recombinant DNA Advisory Committee has advised the Nation Institutes of Health on bioethical issues and established research guidelines since the 1970s.
• Institutional Review Board (IRB) – Some workshop attendees suggested that local IRBs may be more familiar with the researchers they regulate.
• New Regulatory Agency – To "track every ovum," a new agency, much like the United Kingdom's Human Fertilisation and Embryology Authority (HFEA), may be needed, some participants said.

Workshop participants expressed concern over whether stem-cell lines can be developed to reflect the genetic diversity of the entire human population. Such diverse stem-cell lines might support more generalized therapies, of use to a broader population, some said. Others discussed concerns about the source of egg donations: Researchers should only use eggs from women whose intent is to further research--not those who donate eggs for fertility treatments, some workshop participants said.

What is research cloning, and how is it different from reproductive cloning?

Both involve a technique called nuclear transplantation--replacing the nucleus of a donor's egg with the DNA from an adult cell. Under certain conditions, the resulting entity will begin developing like a fertilized egg. In reproductive cloning, the entity is implanted into a uterus, where it has the potential to develop into a full organism; a clone of the donor of the adult cell. In research cloning, the entity is not implanted in a uterus. Instead, after several days, researchers harvest embryonic stem cells, which theoretically can develop into any type of cell and, according to many researchers, may someday be used to treat neurodegenerative diseases or other conditions.

A complete copy of the AAAS report may be found online at http://www.aaas.org/spp/cstc/issues/cloningreport.pdf.

The American Association for the Advancement of Science (AAAS) is the world's largest general scientific society, and publisher of the journal, Science (www.sciencemag.org). AAAS was founded in 1848, and serves some 265 affiliated societies and academies of science, serving 10 million individuals. Science has the largest paid circulation of any peer-reviewed general science journal in the world, with an estimated total readership of one million. The non-profit AAAS (www.aaas.org) is open to all and fulfills its mission to "advance science and serve society" through initiatives in science policy; international programs; science education; and more. For the latest research news, log onto EurekAlert!, www.eurekalert.org, the premier science-news Web site, a service of AAAS.