The guidelines spell out the ethical and scientific criteria that the National Institutes of Health will weigh as it considers the first applications for federal grant money to study human embryonic stem cells.
Those cells, which could be obtained from embryos donated by patients at fertility clinics, are widely believed to carry the potential to treat a range of diseases, including diabetes and neurological disorders such as Alzheimer's and Parkinson's.
Opponents say the research is unacceptable because the only way to acquire the cells is by destroying human embryos.
The guidelines will insist that federal research be conducted only on cells taken from frozen embryos that were destined to be discarded anyway, sources briefed on the plan said.
Moreover, federal money could not be used for the destruction of embryos to get the cells. That job would have to be done by privately funded researchers who could then pass the useful cells to federally supported scientists. Opponents contend that such a separation of responsibility for the embryo's destruction would be morally meaningless.
The new rules will disallow payments to embryo donors and will preclude donors from specifying who should receive their embryo's stem cells. Those provisions aim to discourage the creation of a market in embryo cells and block any incentive for a woman to create fresh embryos just to provide a potential treatment for a sick relative.
Patient-support groups immediately hailed the new rules, which were delayed for more than a year after the NIH was flooded with public comments about an earlier draft. One source close to the process said that those comments initially ran strongly against allowing such research but that patient-advocacy groups later caught up and helped turn the tide.
"We're very supportive of this research," said Robert Goldstein of the Juvenile Diabetes Foundation in New York. "We'd like to see work go forward in this field, which we think has extraordinary promise."
Better than adult cells?
But others, citing recent evidence that certain cells from adults may hold much of the curative potential previously believed unique to embryo cells, threatened to derail the research funding effort.
"It's becoming harder and harder to argue that embryonic cells have uses that adult cells do not," said Richard Doerflinger, associate director of the Secretariat for Pro-life Activities at the National Conference of Catholic Bishops. "I think the decision to release this during [congressional] recess is deliberate. They hope the flak will die down by Labor Day."
Members of Congress vowed to pick up the issue when they returned.
"I don't think that they by law should be allowed to do this," said Rep. Jay Dickey, R-Ark., who for the last four years has co-sponsored an amendment to the NIH appropriations bill that precluding federal funding of any research that results in the destruction of human embryos. Last year, lawyers at the Department of Health and Human Services determined that the provision did not preclude stem cell research.
"We're talking about dismembering a living being, according to our interpretation," said Mr. Dickey, adding that he would consider filing a legislative amendment to clarify his position.
Scientists countered that embryos are not "dismembered" to get stem cells because retrieval is conducted when the embryo is still a one-week-old microscopic ball of undifferentiated cells, long before any organs or limbs have developed.
Developments in Britain
They noted that last week, a British government advisory commission came out in favor of far more permissive rules on human embryo research. They would allow scientists there to create cloned human embryos from scratch for research as long as they are destroyed within 14 days, when the first evidence of nerve cells appears.
According to one source who participated in an NIH briefing late Tuesday, the agency plans to appoint an advisory committee of scientists and ethicists to review all embryo-cell grant applications submitted to the NIH's Office of Science Policy. That committee will have its first meeting in December.
Applications that pass first muster will be forwarded to the NIH scientific review advisory committee, which is scheduled to have its next meeting in January and which can forward promising applications to the grant-judging committees within the NIH's individual funding institutes. That means the first awards could be announced late next year at the earliest, the source said â€“ assuming that Congress and the next president do not interfere with the process.
The final rule closely tracks the wording of last year's draft rule, sources said, but has added provisions to address public concerns. That includes stronger language to ensure that donors fully understand that their embryos will not survive the procedure and that cells from their embryos may be kept alive indefinitely and may be made into tissues that could ultimately be transplanted into patients.
Separation of duties
The guidelines state that federally funded researchers who want to conduct research on stem cells would have to arrange for someone else to retrieve those cells and would have to certify to the NIH that they were retrieved in accordance with federal rules.
"It would be very tough for the public to take argument with this rule-making process, which has reached out to ethicists, religious leaders, scientists, patient groups, physicians and others in a very sincere attempt to provide a mechanism to exploit what may be the biggest breakthrough in medicine in the past 10 years," said Daniel Perry, chairman of Patients' Coalition for Urgent Research, created last year to support stem-cell research.
Mr. Perry said the potential medical benefits for the desperately ill outweigh any ethical reservations about embryo research.
"What the patient groups have been saying along is, 'Get on with it. We want this for our loved ones,'" he said.