The federal government has opened the door to research on embryonic stem cells, and is now to determine what ethical chains to join. But researchers in California are worried that the expected limits could still cause aggravation if they do not fit the standards of their own funding agency, the California Institute of Regenerative Medicine (CIRM). Issues involving both the consent and the source of the embryos are under discussion.
Scientists say that the draft rules enacted by the National Institutes of Health, 17 April will put some lines, including scientifically valuable cell lines approved under the Bush administration -out limits. The NIH project requires written by couples state that they were informed of the "alternatives" before giving their embryos. Often couples are said other options orally, but it is not part of the written informed consent, said Geoffrey Lomax, senior officer for medical and ethical standards at CIRM. The institute noted that its rules have the seal of approval of the National Academy of Sciences and the International Research Society for Stem Cell.
"As the leading provider of research funding on human embryonic stem cells in the world, CIRM's interest to ensure that the rules of the NIH comply with medical and ethical standards of CIRM," the institute said in a draft declaration. If the federal government put excessive eligibility bar, CIRM said, "some scientifically important lines can not qualify." One way to avoid the problem, he says, is for the NIH to consider "grandfathering" in established lines that might not otherwise qualify. The CIRM statement also recommends the creation of a register of "consistent lines."
Everybody needs to be in line as far as possible, the draft declaration emphasizes, to eliminate confusion and red tape that would otherwise ensue in studies of a mixture of federal funding and state. While it is possible to have consistency in the consent procedures, there will always be a gap between the federal and state rules regarding the source of stem cells, because scientists federally funded will still not be allowed to derive new cell lines. this involves the destruction of an embryo, which is prohibited by the Congress by the so-called Dickey-Wicker amendment that prohibits the use of federal funds for research on embryos. One reason for the creation of CIRM was to allow scientists to produce new cell lines, including the controversial method called research cloning and yet unproven, or nuclear transfer of somatic cells.
The new working group is expected to report by the end of May in a long time to NIH to be careful before issuing final guidelines in early July.
CIRM board should approve the creation of a working group to assess the NIH draft guidelines at its 2-day meeting this week.
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