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Wednesday, April 27, 2005

Law/Biotech - Stem Cell Guidelines Issued

The Washington Post reports today:

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. * * *

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.

The entire report, "Guidelines for Human Embryonic Stem Research," may be read online here.

Meanwhile, Senate Bill 268 is in conference committee. According to the Action List, one conference report was submitted, then withdrawn. For background, see this Jan. 14th ILB entry and this one from Jan. 17th.

Posted by Marcia Oddi on April 27, 2005 08:04 AM
Posted to Biotech | Indiana Law