US agency outlines framework for funding human embryonic stem-cell work.
The National Institutes of Health today released a comprehensive set of draft guidelines intended to govern federally funded human embryonic stem cell research. The provisional rules were published 38 days after President Barack Obama signed an executive order freeing up federal money for research on hundreds of human embryonic stem cell lines.
The guidelines limit federal funding to research on stem cell lines derived from embryos created by in vitro fertilization (IVF) solely for reproductive purposes, and no longer needed for that purpose. Parents would have to voluntarily donate the embryos, without inducements and without researcher influence.
Disappointing some researchers, the guidelines explicitly disqualify from funding any stem cell lines derived from embryos created for research purposes, whether by standard IVF methods or by somatic cell nuclear transfer. No such lines are currently known to exist. The draft guidelines also forbid funding for lines derived through parthenogenesis, a form of asexual reproduction in which an unfertilized egg is developed into an embryo. The International Stem Cell Corporation, a California company, has reported deriving stem cells from parthenotes.1
In lifting restrictions imposed by President George W. Bush in August 2001, which limited federal funding to only a score of lines derived before then, Obama ordered the NIH to develop guidelines governing federally funded stem cell research within 120 days; the NIH now has 82 days left to complete the process. It will issue the guidelines formally next week in the Federal Register, kicking off a 30-day public comment period. After that, the biomedical agency will make any changes it deems necessary in response to the comments it receives and will issue final guidelines on or before 7 July.
"This is a significant new step and will lead, in a relatively short period of time, to a greatly increased number of stem cell lines available for federal funding," Raynard Kington, the NIH's acting director, told reporters during a 17 April teleconference. He noted that, once the guidelines are finalized, the agency will periodically revisit them to see if adjustments are needed to reflect evolving science.
Kington says that, using an unofficial agency analysis of banks and registries worldwide, the NIH estimates that more than 760 human embryonic stem cell lines are in existence. Although it is impossible to know how many will meet NIH eligibility standards before they are finalized, he says he expected "many" to do so, opening up to federally funded scientists a trove of genetically diverse cell lines, a significant number of which represent specific diseases.
Stem cell research topics are among the many topics being funded by $200 million in Challenge Grants made available through the NIH's recent economic stimulus windfall. Kington said that the review and funding of applications for stem cell research proposals will be deferred until the final guidelines are issued. At that point, researchers will have the opportunity to modify their applications to comply with the guidelines before funding decisions are made.
Advocacy groups and scientists that support the research applauded today's development. "We're thrilled that the next step in this process has come to fruition and that the draft guidelines are out," says Amy Comstock Rick, president of the Coalition for the Advancement of Medical Research, an umbrella group of organizations that backs federal funding for the research.
Mark Kay, a geneticist and stem cell researcher at Stanford University in Palo Alto, California, said he would have liked to see the guidelines embrace stem cells derived outside the reproductive context. Still, he says, the draft effort "is a step in the right direction".
Meri Firpo, who uses stem cells in diabetes research at the University of Minnesota, called the guidelines "reasonable", but added that "there are some specific issues that probably need clarifying". Among them, she said, is the guidelines' silence on whether lines derived from embryos created from donated sperm or ova would qualify — under guidelines adopted in the past by the US National Academies, they do not qualify. Firpo, who derives stem cell lines, says that to comply with the Academies' guidelines, she has had to turn away offers of embryos because sperm or egg donors were used for their creation.
Those who oppose the research because deriving stem cell lines requires the destruction of days-old embryos say that the guidelines would vastly expand an enterprise they deplore. "It's forcing American taxpayers to spend their money creating essentially an incentive to create and destroy more human embryos," says David Christensen, senior director of Congressional affairs at the Family Research Council in Washington DC.
Christensen noted that the guidelines don't require the fertility doctor and the researcher to be different people, but say only that that this should be the case "whenever it [is] practicable". "This is really crafted with huge loopholes," he says.
Revazova, E. S. et al. Cloning Stem Cells 9, 432–449 (2007).