Quotes of the Day

The National Institutes of Health (NIH) issued official guidelines on Monday governing the federal funding of human embryonic-stem-cell research, four months after President Obama signed an executive order overturning the longstanding federal ban.

The Obama Administration has significantly expanded the number of stem-cell lines that may now be eligible for study using federal funds. Since 2001, under a Bush Administration ban, no new stem-cell lines could be created or studied using government dollars (though financing was allowed for research on a few dozen or so stem-cell lines that were already in existence), but some estimates suggest that since Bush's policy was implemented, as many as 700 new human embryonic-stem-cell lines have been created through private funding, mostly using embryos discarded by IVF clinics — and many of those lines may now qualify for public funding.

"The guidelines allow NIH to fund scientifically worthy research using responsibly derived human embryonic stem cells," Dr. Raynard Kington, acting director of the agency, said in a telebriefing with reporters on Monday.

The new rules, which also establish the first federal registry of eligible stem-cell lines, were immediately applauded by scientists and by various patient advocacy groups. "These guidelines will bring us closer than ever toward unleashing the promise of embryonic-stem-cell-research and maximizing its therapeutic potential for patients with Type 1 diabetes," said Alan Lewis, president of the Juvenile Diabetes Research Foundation.

Starting Tuesday, all U.S. stem-cell researchers must follow the NIH guidelines in creating new stem-cell lines in order to receive federal support. For all lines created before Tuesday, researchers may now receive federal funds if the creation of their stem-cell lines adhered to the spirit, if not the letter, of the new regulations.

The guidelines allow the NIH to fund the creation and study of new stem-cell lines, as long as they originate from embryos that were discarded during the IVF process and donated, with proper informed consent, to research. Government funds still may not be used, however, to create an embryo specifically to destroy it for research purposes, or to create or study stem cells derived from embryos generated by other methods, including cloning and parthenogenesis, in which the egg is directly activated to start dividing and generate an embryo.

In establishing standard criteria for obtaining informed consent from potential donors, the NIH said its main goal was to separate the donation process from the IVF process in order to ensure that donors understand that their IVF experience will not be affected in any way by their decision to discard or donate unused embryos. Donors must be specifically advised that their embryos may be used for stem-cell studies, and may result in commercial products for which they should not expect any financial or medical benefit.

The informed-consent guidelines reflect concerns expressed by researchers, IVF consumers and ethicists that while nobody can predict how donated embryos may end up being used in research, couples undergoing IVF should be made fully aware of the widest range of possibilities. Overall, the NIH rules took into account 49,000 comments submitted to the agency by scientists, patient advocates, medical and religious organizations, private citizens and members of Congress during a public comment period.

The largest concern among stem-cell experts involved the status of the few dozen stem-cell lines that had qualified for federal funding, even under Bush's more restrictive policy. Stem-cell lines derived from those embryos are currently seeding many different studies, but because the embryos were not donated under the same stringent informed-consent procedures that will be required starting Tuesday, it's possible they may no longer be eligible for federal financing.

The NIH is asking scientists working with these lines to submit as much documentation as possible to demonstrate that the embryos were donated voluntarily, without coercion and without any monetary benefit to the donors. This material will be reviewed by a select group of scientists, ethicists and community members that will be convened over the next few months as part of a working group of the advisory committee to the director of the NIH.

"They will be exercising judgment, and considering whether the principles of voluntary informed consent were followed, even if the step-by-step procedures currently required were not followed in the derivation of that stem-cell line," said Kington.

It's not yet clear exactly what criteria the working group will use to determine eligibility. But it's possible that stem-cell lines could be excluded from federal funding if, for example, the embryo donors had not been made aware that their embryos would be used for stem-cell research, or if they had given consent for their embryos to be studied only for a specific period of time. If those embryos had been used to generate stem cells, which can theoretically survive indefinitely in a lab dish, the donors may not have technically approved that research.

"We will have to look at what's out there, and determine whether we believe it meets our standards," said Kington.

Kington said that the NIH would continue to review its guidelines for funding eligibility — in particular, regarding cell lines derived from embryos created outside the IVF process. "We know there is strong sentiment in this country for supporting federal funding of research involving cell lines from embryos created for reproductive purposes that otherwise would be destroyed," said Kington. "We don't believe there has been public discussion yet of the ethical guidelines regarding alternative sources of embryonic stem cells. We will reconsider the guidelines as science evolves, and as the public discussion over the ethical principles evolves."

If the speed with which stem-cell advances in recent years have been made is any indication, those revisions may be on the horizon very soon. "These NIH guidelines represent a reasonable compromise, based on where the science stands today," says Dr. Sean Morrison, director of the Center for Stem Cell Biology at the University of Michigan. "But this field is evolving at an incredibly rapid pace, and it may be necessary, down the road, to revisit some of the elements on this policy as the science evolves."

• Alice Park
• New government regulations for the funding of human embryonic-stem-cell research will significantly expand the number of studies on stem-cell lines that qualify for public funds