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Draft rules expand stem cell research options

Call for strict limits on use of embryos

By Bina Venkataraman
Globe Correspondent / April 18, 2009
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The federal government yesterday released its draft rules for funding embryonic stem cell research - expanding opportunities but stopping short of allowing government-sponsored scientific projects to use human embryos created solely for experimental purposes.

The National Institutes of Health proposed limiting federally funded research to use of embryos that would otherwise be discarded from fertility clinics. That is expected to significantly expand the number of stem cell lines available to researchers who seek to do basic research and develop treatments for a variety of intractable diseases.

But the Obama administration made clear it does not intend to finance research that uses embryos created solely for research purposes or cloned by scientists - more controversial procedures with less public and congressional support.

The proposed rules "look narrow on the surface and they are narrow," said Sheila Jasanoff, a professor of science and technology studies at Harvard's Kennedy School. "It's trying not to get into the morally thorny territory of creating embryos for research, which is unsettled and undeliberated - and potentially politically quite messy."

The proposed guidelines for receiving federal money will be open to public comment before they are made final in July.

Within minutes of yesterday's announcement, researchers in the Boston area publicly praised the proposed rules for making new research possible. Privately, some expressed concern that the rules might exclude certain lines of stem cells currently in use because there is no paper trail showing the original donors consented to their use. Some scientists elsewhere in the country are also concerned that the guidelines exclude cloned embryos that could be used to develop genetically tailored organs more effective for transplant.

"It is an important step forward," said Dr. Terence Flotte, dean of the University of Massachusetts Medical School in Worcester, of the draft guidelines. "It probably would open up scores of existing [stem cell] lines for research." Once final, the new rules will allow researchers to get to work quickly, said Flotte. In the fall, UMass Medical School established a stem cell bank and registry that it hopes to expand with federal funding.

Under the Bush administration, government-funded research could use only the relatively few stem cell lines already extracted from human embryos as of summer 2001. The policy was aimed at preventing scientists from destroying any more embryos to extract stem cells.

B.D. Colen, spokesman for the Harvard Stem Cell Institute, said the draft guidelines "clearly reflect a great deal of careful consideration of the scientific and ethical issues involved." The institute plans to make detailed comments before the rules become final, Colen said.

Some researchers believe cloned embryos are important in developing genetically matched organs for transplant. But projects that use these more controversial human embryos are expected to continue, said Dr. Leonard Zon, director of the stem cell research program at Children's Hospital Boston, as long as they retain the support of private philanthropists.

"The ability to have NIH funding to work on embryonic stem cells is really going to move our progress of translating cells into the clinic," Zon added. "We see these cells as advancing the field very far."

Some researchers are concerned that the funding guidelines, which require that embryo donors be informed of their options and consent in writing to their scientific use, would exclude stem cells that are currently in use, because it may no longer be possible to identify their donors. Human embryonic stem cells have been largely separated from information to maintain donors' privacy.

But Dr. Raynard S. Kington, acting director of the National Institutes of Health, said in a conference call that research supported by the NIH already underway on stem cells would continue. "There can be no question that these proposed guidelines will greatly expand scientific opportunity," he added.

In response to public pressure to seek better treatments for illnesses including cancer and Alzheimer's disease, Congress has twice passed laws to approve federal funding for stem cell research that uses human embryos from fertility clinics. On both occasions, President Bush vetoed the legislation.

Bina Venkataraman can be reached at bina@globe.com.

Dr. Leonard Zon of Children's Hospital said controversial projects will continue as long

as they have private support.

'Advancing the field'