Guidelines proposed for stem-cell research

The plan would set up local review boards and restrict research that introduces human cells into animals.

The debate over the use of embryonic stem cells in medical research has been batted between Congress, President Bush, state legislatures, and the United Nations. Now it's about to go from high-level politicians to local review boards.

That's one likely result of new guidelines for human embryonic stem cell research released Tuesday by the influential National Academy of Sciences, a private nonprofit group that advises the government. The guidelines call for new oversight committees to be formed at all institutions conducting such research. While the panel outlined numerous recommendations, these local committees would set their own standards.

"The oversight we call for will in many instances set a higher standard than required by existing laws or regulations," said Jonathan Moreno, a University of Virginia bioethicist who cochaired the Academy panel. "And while we were hesitant to recommend another bureaucratic oversight entity, the burden in this case is justified, given the novel and controversial nature of embryonic stem cell research."

The local committees would include researchers, experts in law and ethics, and members of the general public.

Although compliance with the guidelines is voluntary, the National Academy of Sciences is asking researchers, professional societies, and groups that fund medical research to back the idea.

Leonard Zon, president of the International Society for Stem Cell Research, says his group will endorse the NAS guidelines.

"I think this will set the standard for the field," says Dr. Zon, a professor at Harvard Medical School. It will help "to move the research forward," he says. "It'll help people negotiate through the [approval] process, and I think it will be good for the field."

The guidelines speak of standards for storing and distributing, but not banning, all sources of embryonic stem cells, from embryos already at fertility clinics to embryos produced for research, including those created by somatic cell nuclear transfer (SCNT), sometimes called "therapeutic cloning." Many religious groups have expressed opposition to the use of human embryos in research. The guidelines restrict their use to no more than the first 14 days of growth, before the cells begin to develop into parts of the body.

The inclusion of cloning, or SCNT, may be "a kind of olive branch" to stem-cell researchers, says Jason Robert, a bioethicist and historian of science at Arizona State University in Tempe. "It strikes me as an attempt to get the buy-in from scientists that's going to be required in order for the rest of the recommendations to have any bite."

So-called embryonic stem cell research oversight committees, or ESCROs, would also oversee the donation of early embryos for use in research. The guidelines set several parameters:

• Donors should give their consent and understand that their identities could become known and that they would not share in any financial benefits derived from creating stem cells.

• Donors should not be paid to donate embryos.

• Researchers should not pressure fertility clinics to create more embryos than those needed for reproductive treatments.

"The proof is going to be in the pudding," Professor Robert says. "Who knows how the ESCRO committees are going to really respond to the protocols when the time comes?" The ESCROs could, for example, set tighter standards than those laid out in the guidelines. Robert, a Canadian, notes that these guidelines are "more liberal" than those in Canada, which, for example, do not permit embryos to be created for research. "That's remarkable."

Institutions engaged in research, such as universities, foundations, and hospitals, already have Institutional Review Boards (IRBs) that must approve research projects. The ESCROs would not replace the IRBs but augment them. "I think there are a number of issues that go past what IRBs are used to [doing]," Zon says, including tracking which projects are using federal dollars.

The federal government has limited stem cell research using federal funds to cell lines created before 2001. The ESCRO guidelines would govern both those cell lines and others created around the country using private or state funding.

The guidelines also address chimeras, animals into which human cells have been placed for research. ESCRO approval should be obtained before chimeras are created, the guidelines say. And no embryonic stem cells from animals should be put into a human embryo. Human embryonic stem cells should not be transplanted into nonhuman primates, such as monkeys or chimpanzees. That position, Robert says, probably recognizes that research on primates "is about as politically sensitive a topic as you can find" outside of abortion.

Chimeras should be created only when no other research method is available. Introducing human cells into animal brains, for example, would be permitted only with a strong scientific justification. An example, Zon says, is creating mice with human bone marrow to study blood diseases, before a clinical trial in humans.

Overall, Robert sees the guidelines as a "nice compromise," recognizing the need for oversight beyond what we have now "but at the same time also warn against the danger of too much oversight."

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