Scientists have expressed their satisfaction with the final guidelines on research with human embryonic stem cells (ES) issued today by the National Institutes of Health.
The new rules, which set the criteria for determining the ES cell lines can be used in experiments funded by the federal, NIH gives discretion to approve the old lines that do not meet modern requirements ethical stringent. And they call for NIH to establish a register of eligible lines. The rules add "an important step in the right direction for research on stem cells," says Harvard University stem cell researcher George Daley.
As draft guidelines issued in April, the new rules limit federal funding for work on derived ES cells from surplus embryos donated by couples receiving fertility treatment. (Federal funds can not be used to derive ES cells under a congressional ban called 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 laboratories, would qualify under detailed provisions regarding the informed consent of embryo donors set out in the guidelines. The answer is that there is no "grandfathering" of Bush automatic lines. However, a working group will deal with them on a case by case basis, recommending their approval if they are within the spirit if not the letter of the guidelines.
As Acting Director Raynard Kington NIH explained at a press conference, there will be separate channels to determine if a cell line is permissible under it was obtained before or after July 7, the effective date of the guidelines. For those derivatives or later, there will be a routine administrative review to see that they comply with the requirements of informed consent. If these lines are derived outside the United States, NIH will decide whether the rules under which they were obtained are "at least equivalent" to the rules of the NIH, said Kington.
The determination of the admissibility of cell lines derived before 7 July will require "more complicated exercise of judgment," Kington said. For this, a working group, an advisory subcommittee of Director NIH-committee will determine whether they were obtained within the framework of the principles of the guidelines, including informed consent and the absence of compensation for embryos.
Some scientists, such as Kevin Eggan at Harvard, were disappointed that the NIH did not open the door to the use of embryos created for research purposes, including the transfer of somatic cell nuclear (cloning) and parthenogenesis (from an unfertilized egg) . But "on balance, the guidelines are a vast improvement on the draft guidelines," says Eggan. "The registry establishment is a significant improvement, as the road clearly established for the approval of lines that require" grandfathering "." Stem cell researcher Sean Morrison of the University of Michigan Medical School in Ann Arbor welcomes NIH for "a very good job." He also says creating a new registry is "very important because it would take enormous resources for each institution to determine themselves" if a qualified given line for federal support. Morrison also provides that "all or most" of the 21 approved Bush lines will rally with the working group.
Kington predicted that as the new registry NIH stem cells and the working group, composed of nine or 10 scientists, ethicists and members of the public will be in business in the next two months.
How many lines will eventually make it to the registry is uncertain. Kington said there have been references to more than 700 new lines "there." But he said a much smaller number are widely used and can be expected to go on the register.
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