Biomedical agency announces new funding policy for cell lines.
Nearly 11 years after Wisconsin-led researchers reported the first isolation of human embryonic stem cells, the field became eligible this week for broad research funding by the US government.
In final guidelines that went into effect on 7 July, the National Institutes of Health (NIH) established a process that will allow scientists who hold stem-cell lines derived before this date to apply for their inclusion in an agency-established registry of fundable cell lines.
In doing so the agency, based in Bethesda, Maryland, acknowledged that the strict ethical conditions it laid out in draft guidelines published in April (see Nature 458, 950–951; 2009) may have excluded many existing cell lines from federal funding. After receiving more than 49,000 comments on the draft guidelines, "it became clear that there were lines that responsible people would all agree were responsibly derived … but might not meet the exact guidelines that we have put forth," said Raynard Kington, acting NIH director, on 6 July.
A working group will be established to judge on a case-by-case basis whether pre-existing lines "meet the principles underlying the guidelines", he said. Those principles remain unchanged from the April draft: fundable lines must be derived from embryos that were created solely for reproductive purposes and are no longer needed. Parents must voluntarily donate the embryos without inducements or researcher influence, and written informed consent must be obtained.
The final guidelines, like the draft ones, exclude funding for stem cells derived from embryos created for research, whether by in vitro fertilization, somatic cell nuclear transfer or parthenogenesis, when an unfertilized egg is developed into an embryo.
Although lines created in the United States from 7 July onwards will have to follow the guidelines to the letter, scientists who create lines abroad in future may apply to the working group to demonstrate that a line was made under procedural standards that are "at least equivalent" to those provided in the final guidelines. The NIH director will give the final approval to all decisions made by the group.
Kington said he expected the group to comprise nine to ten people, including ethicists, scientists and fertility doctors, and to be up and running "within the next couple of months", along with the new registry.
“The NIH has done what is best for the field by having their own registry — one list that everyone can work from. ”
Many scientists were delighted with the final guidelines. "It's a huge step forward," says George Daley, a researcher at Children's Hospital Boston and the Harvard Stem Cell Institute in Cambridge, Massachusetts. "It's flexible and science friendly."
Sean Morrison, a stem-cell biologist at the University of Michigan in Ann Arbor, adds: "The NIH has done what is best for the field by having their own registry — one list that everyone can work from."
Some scientists, including Daley, said that they were disappointed with the exclusion of embryos derived for research purposes, but pointed out that the agency intends to revisit the guidelines as the science evolves.
The NIH guidelines depart in one significant way from existing National Academy of Sciences standards; they do not require consent from gamete donors — only from the couple seeking in vitro fertilization services.
The guidelines respond to an executive order issued in March by President Barack Obama (see Nature 458, 130–131; 2009), who lifted restrictions imposed by President George W. Bush on 9 August 2001.