Federal regulators on Monday set new rules for government financing of stem-cell research. The rules will allow such work if a review panel determines that couples gave the necessary “informed consent” for the use of their embryos. Scientists will get the chance to demonstrate to the review panel that older cell lines, created during the past decade and crucial to continuing research, meet this ethical standard.
The creation of a review panel, as part of final guidelines for stem-cell research issued by the National Institutes of Health, resolved one of the major complaints of scientists awaiting the implementation of President Barack Obama’s March 9 promise to allow expanded federal support of stem-cell research.
The new federal policy “will greatly expand opportunities for stem-cell research and will ensure that NIH-funded research using human embryonic stem cells will be conducted in an ethical and responsible way,” said Raynard S. Kington, acting director of the NIH, in a briefing for reporters.
The NIH guidelines, which take effect Tuesday, won immediate endorsement from researchers and university groups, including the Association of American Medical Colleges and the Association of American Universities.
The policy reflects “a thoughtful and balanced approach,” said David T. Scadden, co-director of the Harvard Stem Cell Institute.
Embryonic stem cells, because of their potential to grow into any of more than 200 types of tissue in the body, raise the possibility of cures for a range of ailments that include cancers, diabetes, and heart disease.
Former President George W. Bush, siding with those who believe any potential human life form should be preserved, ruled on August 9, 2001, that federal money could not be involved in any projects using embryonic stem cells created after that date. Mr. Obama announced his intention to overturn Mr. Bush’s policy in March and asked the NIH to draft detailed rules for stem-cell use.
Those new rules say that, from today forward, the government will provide money for embryonic-stem-cell research only when the couple who produced the embryo can be shown to have fully understood the scientific implications and have given clear approval.
For stem-cell lines that originated before Tuesday, the NIH will establish a review committee of about 10 science and ethics specialists who will decide whether the embryonic stem cells were “derived responsibly,” Dr. Kington said.
The reviews will determine whether principles of informed consent “have been met even if every specific detail outlined in the final policy was not followed,” Dr. Kington said. In the case of stem-cell lines from foreign sources, the committee will determine if the country’s consent standards “are at least equivalent” to the U.S. policy, he said.
The result is a policy “much more workable and practical” than scientists had feared, Dr. Scadden said. “The panel still needs to be named,” he said, “but experience thus far suggests that this administration appoints those with substantive credentials.”
The NIH will also establish a registry of approved lines. “That will make the process much simpler for institutions and individual investigators,” Dr. Scadden said.
The federal government is now spending about $88-million a year to support embryonic-stem-cell research. The spending could actually decline this year because of delays while awaiting the new NIH policy but should then grow substantially in future years, Dr. Kington said.
