By Rick Weiss
Washington Post Staff Writer
Wednesday, April 27, 2005
Forging into a politically and ethically contentious regulatory void, the National Academies released a detailed set of guidelines yesterday aimed at all U.S. researchers who perform experiments with human embryonic stem cells.
The 131-page report from the nation's premier independent science advisory board contains the first comprehensive -- albeit voluntary -- ethics rules to emerge from years of jostling by scientists, ethicists, patient advocates and others with stakes in the research.
Embryonic stem cells show great therapeutic potential but stir controversy because human embryos must be destroyed to retrieve them. State and private investments have recently driven the field to new heights of activity, but political deadlocks have made federal oversight all but nonexistent.
Even the strict limits that President Bush imposed in August 2001 on federally funded stem cell research focused on which cells could be studied (those from embryos already destroyed by that date) while saying virtually nothing about what can be done with those cells.
The guidelines set standards for procuring stem cells. Most surprisingly, they call for a ban on paying women for their eggs, which until now have been worth thousands of dollars to some donors. The rules also spell out much of what scientists should and should not do with embryos and stem cells once they get them -- setting limits, for example, on the types of animal-human hybrids that ought to be produced.
The Academies, chartered by Congress to advise the nation, have repeatedly expressed support for stem cell research, including studies in which human embryos are cloned and then destroyed to provide stem cells. The new guidelines, created without government funding, do not rehash the old arguments for and against such research but go the next step to encourage "responsible practices," said Bruce Alberts, president of the National Academy of Sciences, a branch of the Academies.
He and others expressed the hope that the guidelines would quickly become the gold standard that universities, research institutes, privately funded scientists and states would follow in the absence of federal rules.
If that happens -- as many scientists yesterday said is likely -- it could greatly accelerate the pace of research by facilitating collaborations among scientists around the country who have been working under varying rules. The guidelines are also expected to help researchers gain faster Food and Drug Administration approval to try their emerging therapies in patients.
All told, said Harvey V. Fineberg, president of the Institute of Medicine, which with the National Research Council led the Academies' effort, the guidelines "are intended to provide the way that will enable freedom of inquiry to flourish."
The report drew kudos from patient advocacy groups and generally strong support from private companies and academia. Opponents of the research blasted it.
"These so-called 'guidelines' for destructive human embryonic stem cell research try to put a good face on an unethical line of research," said Sen. Sam Brownback (R-Kan.). "We should not be destroying young human lives for the benefit of others."
At the core of the report is a recommendation that all research institutions create special review boards to evaluate stem cell research proposals. That would fill a crucial gap, since the federally required Institutional Review Boards already in place at facilities across the country review only research on human subjects -- not embryos or embryonic cells.
Under the guidelines, embryos used for stem cell research must be freely donated by both the biological father and mother in full knowledge that the cells may be cultivated indefinitely and turned into commercial products for which they will receive no compensation.
Payments to egg donors, although now common practice at fertility clinics, should be banned because of the "sensitivities" inherent in the creation of embryos expressly for destruction, said Richard O. Hynes of the Massachusetts Institute of Technology, who co-chaired -- with University of Virginia bioethicist Jonathan Moreno -- the committee that wrote the report.
The rules call for embryos to be cultured no longer than 14 days, when the first hints of a developing nervous system become evident on the barely visible ball of cells.
The guidelines allow for the possibility of making various types of animal-human hybrids, called chimeras. But such experiments would face close scrutiny by the new review boards, and some experiments should be completely off-limits, the report declares. Injection of human embryonic cells into monkey or ape embryos to make primate chimeras would be banned, as would the creation of any human-animal chimera in which a human-like brain would be likely to develop.
Any chimeras that have the biological potential to make human sperm or eggs should not be allowed to breed, the report adds, to prevent creation of a human embryo in an animal's womb.
The full report is at http://books.nap.edu/catalog/11278.html