After years hearing scientists complain that the U.S. federal government funded research on too few human embryonic stem cell lines, Lana Skirboll, who directs the Office of Science Policy at the U.S. National Institutes of Health, has something to tell the stem cell community: “the ball is in their court.” The NIH announced on Monday that it would be accepting applications to determine whether a line is eligible for funding. The process is not without risks: some scientists are quietly concerned that their informed consent procedures could come under criticism, or that they could lose access to non-federal sources of funding if the lines they wish to work with aren’t cleared by the NIH.
Some confusion over the process is already evident. (See Let the vetting begin) Scientists conducting research on a hESC line should not submit it themselves, Skirboll says, but instead find out whether the group that derived the line will submit it. That’s why the draft list is public, she says. “If you see a line that you’re working on that has not been listed, you need to think about your research and talk to the deriver.”
Geoff Lomax, who heads the standards group at the California Institute of Regenerative Medicine. suspects that the evaluation process could get extremely complex, particularly for older lines. One solution, he thinks, is to assess newer lines, which should more closely follow current thinking for informed consent requirements. Setting precedents soon would be useful, he says. “There’s no need to deal with the hardest lines first.”
“I hope like heck we have so many applications that we have that problem,” says Skirboll. The first in-person meeting of the working group will not be scheduled until it’s clear that there are enough lines to evaluate. “We’re hoping that the order doesn’t matter, that we can go through them very quickly.”
Some of the usual suspects are missing from the list of human embryonic stem cell lines waiting to be evaluated by the U.S. National Institutes of Health for their eligibility federal funding. However, according to a draft list provided by the NIH, none of the hES cell lines eligible for funding under the Bush administration have been submitted, nor have any of the lines from Doug Melton’s group at Harvard. (Spokesmen for both the University of Wisconsin, where more most of the previously approved lines were derived, and the Harvard Stem Cell Institute indicated that the lines would be submitted.)
The NIH issued guidelines in July included strict criteria for documenting informed consent. (See Stem cell research expands)Lines created after this date will undergo a simple administrative review for strict compliance with the guidelines. But the more-studied lines derived prior to the guidelines will need to be evaluated one-by-one by an NIH working group to see if they are consistent in spirit with the guidelines. Though lines that do not pass muster with the NIH can still receive research funding from private organizations and individual states, the deliberations of the NIH working group will be made public, these granting agencies may prove reluctant to award funds to material lacking such approval.
Moreover, the evaluation will require universities to submit sensitive material. Any documentation containing personally identifiable information about donors will not be retained by NIH, says Skirboll, and though consent forms and other documentation will not be made public, she says, it will be subject to the Freedom of Information Act..
Institutions have legitimate worries about public overreaction and the disclosure of proprietary information, says Robert Streiffer, a bioethicist at the University of Wisconsin, has raised concerns about the informed consent standards applied to funding hESC lines under the Bush administration. (See When the past catches up with the present.) Nonetheless, he says, “If you’re not willing to publicly disclose the conditions under which you derived your cells, that’s a pretty big red flag”.
With the exception of two lines from biotech company Bresagen, Streiffer thinks lines eligible for funding under President Bush will also be deemed eligible for funding under the Obama administration.
The more interesting question, Streiffer says, is whether the NIH will seek to enforce consent criteria unique to particular lines. For example, he says, hES cells cannot be mixed into human embryos under the Obama guidelines, but consent forms from the University of Wisconsin state that cells cannot be mixed with any sort of embryo.
Skirboll says that specific consent conditions will be posted along with the lists of lines eligible for federal funding, and that grant applications proposing experiments outside these conditions will not be eligible for funding.