Scientists expressed satisfaction with the final guidelines on research with human embryonic stem (ES) cells issued today by the National Institutes of Health.
The new rules, which set out criteria for determining which ES cell lines can be used in federally-funded experiments, give NIH discretion to approve old lines that don't meet stringent modern ethical requirements. And they call for NIH to set up a registry of eligible lines. The rules add up to "a major step in the right direction for stem cell research," says Harvard University stem cell researcher George Daley.
Like draft guidelines issued in April, the new rules limit federal funding to work on ES cells derived from surplus embryos donated by couples receiving fertility treatment. (Federal funds cannot be used to derive ES cells under a Congressional ban known as the Dickey-Wicker amendment.) The big question researchers had was whether the 21 lines approved for use under the Bush Administration, which are still used in many research labs, would qualify under detailed provisions for informed consent by embryo donors that are spelled out in the guidelines. The answer is there will be no automatic "grandfathering" in of the Bush lines. However, a working group will deal with them on a case-by-case basis, recommending that they be approved if they conform to the spirit if not the letter of the guidelines.
As acting NIH Director Raynard Kington explained at a press conference, there will be separate channels for determining whether a cell line is eligible depending on whether it was derived before or after 7 July, the effective date of the guidelines. For those derived on or after that date, there will a routine administrative review to see that they conform with informed consent requirements. If such lines are derived outside the United States, NIH will decide if the rules under which they were obtained are "at least equivalent" to NIH rules, said Kington.
Determining eligibility of cell lines derived before 7 July will require "more complicated exercise of judgment," said Kington. For this, a task force—a subcommittee of the NIH director's advisory committee—will determine whether they were obtained within the principles of the guidelines, including informed consent and the absence of remuneration for embryos.
Some scientists, such as Kevin Eggan at Harvard, were disappointed that NIH didn't open the door to the use of embryos created for research purposes—including through somatic cell nuclear transfer (cloning) and parthenogenesis (from an unfertilized egg). But "on balance, the guidelines are a vast improvement over the draft guidelines," says Eggan. "The establishment of the registry is an important improvement, as is the clearly established route to approval for lines that need 'grandfathering.'" Stem cell researcher Sean Morrison of the University of Michigan Medical School in Ann Arbor lauds NIH for "a really good job." He also says establishment of a new registry is "really important because it was going to take enormous resources for each individual institution to ascertain for themselves" whether a given line qualified for federal support. Morrison also predicts that "all or most" of the 21 Bush-approved lines will pass muster with the task force.
Kington predicted that both the new NIH stem cell registry and the working group, comprising nine or 10 scientists, ethicists, and members of the public, will be in business within the next 2 months.
How many lines will ultimately make it to the registry is unclear. Kington said there have been references to more than 700 new lines "out there." But he said a far smaller number are in widespread use and may be expected to go on the registry.