California's Stem Cell Scientists Fear Federal Red Tape

The federal government has opened the door for human embryonic stem cell research, and it's now figuring out which ethical strings to attach. But California researchers are worried that the expected limits could still cause them aggravation if they don't jibe with standards set out by their own funding body, the California Institute of Regenerative Medicine (CIRM). Issues involving both consent and the source of the embryos are under discussion.

Scientists say the draft rules issued by the National Institutes of Health on 17 April will put some scientifically valuable cell lines—including lines approved under the Bush Administration—off limits. The NIH draft requires that couples state in writing that they have been informed of "alternative options" before donating their embryos. Often couples are told about other options orally, but it's not part of the written informed consent, says Geoffrey Lomax, senior officer for medical and ethical standards at CIRM. The institute notes that its rules have the stamp of approval from the National Academy of Sciences and the International Society for Stem Cell Research.

"As the largest funder of human embryonic stem cell research in the world, CIRM has an interest in ensuring that the NIH rules are consistent with CIRM's medical and ethical standards," the institute says in a draft statement. If the feds set too high a bar for eligibility, CIRM says, "some scientifically significant lines may not qualify." One way to avoid the problem, it says, is for NIH to consider "grandfathering" in established lines that might not qualify otherwise. The CIRM statement also recommends creation of a registry of "compliant lines."

Everybody needs to be in synch as far as possible, the draft statement points out, to eliminate the confusion and red tape that would otherwise ensue in studies involving a mix of federal and state funding. While it's possible to have consistency in consent procedures, there will still be a disconnect between federal and state rules when it comes to the source of stem cells, because federally funded scientists will still not be allowed to derive new cell lines. That involves the destruction of an embryo, which is forbidden by Congress through the so-called Dickey-Wicker amendment, which bans the use of federal funds for research on embryos. One reason for the creation of CIRM was to enable scientists to produce new cell lines, including through the controversial and as-yet-unproven method called research cloning, or somatic cell nuclear transfer.

The new task force is supposed to report out by the end of May—in plenty of time for NIH to pay heed before it issues final guidelines in early July.

The CIRM board is expected to approve creation of a task force to assess NIH's draft guidelines at its 2-day meeting this week.

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