Lingering Concerns Remain About NIH Stem Cell Rules

UPDATE: NIH posted a notice today saying that ongoing research on previously approved stem cell lines can continue.

BARCELONA, SPAIN—Science was the main topic of conversation here yesterday at the International Society for Stem Cell Research’s (ISSCR’s) annual meeting. But three other items distracted researchers. First, the weather—it poured rain all afternoon, marring planned tours of this beautiful city. Second, a Spanish leg of the Tour de France rolled into town late in the afternoon, and I must admit I sneaked out of the poster sessions for 20 minutes to see the riders zoom by. But the third issue dominating conversations here was politics. While American stem cell researchers were celebrating the final NIH stem cell guidelines, questions remain, particularly whether the National Institutes of Health will approve existing lines in time for use with stimulus funds. And in Europe, politics concerned the Italian scientists here as several of them are suing the government to force it to include human embryonic stem in its stem cell funding.

Regarding the new NIH guidelines, which took effect on Tuesday, 7 July, Kevin Eggan of Harvard University noted that he spent Tuesday night talking to Harvard lawyers about whether he needed to shut down experiments in his lab. While he has been working with federally-approved human ES lines, he notes that those lines could be considered illegal until they get vetted by the stem cell working group NIH plans to create. Indeed, if one looks closely at all the informed consent requirements, Eggan argues that all existing human ES lines will have to get waivers from the NIH working group to be studied with federal funding. “There are no human ES lines that currently meet NIH guidelines,” he says.

Eggan ultimately decided his group didn’t need to stop lab work, but he says there remains a lot of uncertainty about the new guidelines. For example, both Eggan and George Daley of Children’s Hospital Boston wonder who will be on the NIH working group and how quickly it will review, and hopefully approve, existing human ES lines. “We’re concerned there will be more and more delays,” says Daley, who noted that ISSCR officials arranged a call late in the evening here to talk to NIH officials about the guidelines.

The biggest question seems to be whether NIH can approve lines fast enough that they can be used with stem cell grants submitted to NIH for the money allocated under the U.S. economic stimulus plan. (NIH's deadline for awarding the 2009 stimulus grants is 30 September.) Eggan says his grants specified what cell lines he preferred to use, but also noted alternatives in case the guidelines didn’t approve those lines. But he doesn’t know if all researchers went to that trouble. What if a grant is approved but the human ES line involved hasn’t made it through the working group? NIH sought to reassure ISSCR officials they would resolve that issue but didn’t specify how. “No one knows. The fact is it’s uncertain,” says Eggan. Still, Daley says that despite these lingering concerns, the general mood about the new guidelines is “grateful.”

While American stem cell scientists may be getting freed of politics, those in Italy can’t say the same. Human ES cell research is legal in Italy but that doesn’t mean the government has to fund it. As Nature detailed last week, one Italian science agency recently sent out a call for stem cell grant proposals but specifically excluded human ES cell research, leading three Italian scientists to sue the government. Elena Cattaneo of the University of Milan is one of those researchers and at a press conference here, she lamented the “strong political interference” with science and said it violated Italy’s constitutionally protected freedom of scientific research. She said she and her fellow plaintiffs expect the lawsuit will be settled quickly.