by Claudia Kalb

The people have spoken, and the NIH has responded. A month ago, we reported that the NIH had received 49,015 comments in response to its draft guidelines for human stem-cell research. Now, after reviewing all the input—from scientists, medical groups, religious organizations, private citizens, and member of Congress—the government’s final guidelines are out, and they’re being applauded for one major change: stem-cell lines that have been ineligible for federal funding in the past may now qualify for government dollars. That’s welcome news for stem-cell scientists who don’t have private money to do their work.

The key sticking point has been informed consent, the process that walks individuals through the ins and outs of donating their embryos to science. When the draft guidelines came out in April, many scientists expressed concern about the rigid requirements that were outlined, since many of the lines already created—including some of the 21 lines approved for use by President George W. Bush—wouldn’t meet the new standards. In a press conference announcing the final guidelines, the NIH’s acting director, Dr. Raynard Kington, said it became clear that the standards for informed consent had changed over time and that there were also a variety of standards out there, from the National Academy of Sciences to the International Society for Stem Cell Research. Kington said lines exist that “reasonable people would all agree were responsibly derived.” The new guidelines allow scientists to submit a request to a group of nine or 10 experts now being assembled. The group will assess whether or not the stem-cell lines researchers want to use uphold the principles of informed consent; if so, they’ll be approved for federal funding. (New lines that have yet to be created, on the other hand, must follow the new guidelines, which go into effect July 7, 2009.) The NIH will also create a new registry in the next couple of months, which will list all the stem-cell lines eligible for federal funding as they are approved.

The new guidelines still don’t allow federal funding to be used for somatic-cell nuclear transfer (SCNT), or so-called therapeutic cloning. Some scientists want to use this technique to create cells that have genetic conditions built in. But Kington said that while there’s been a “strong sentiment” in the country supporting government money for stem cells derived from embryos, there’s been little public discussion about alternative stem-cell sources. He said the NIH will follow public discussions as they evolve and will update the guidelines when they feel compelled to do so.

For now, a new era in stem-cell science begins. The president of the Juvenile Diabetes Research Foundation sent an immediate and enthusiastic response: “We thank the NIH and the Obama Administration for renewing our hope for a cure.”