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Britain's Human Fertilisation and Embryology Authority (HFEA) said on Wednesday (August 11) that it had granted the country's first license to create human embryonic stem cells using cell nuclear replacement.
"We're absolutely thrilled," said Alison Murdoch, a member of the Newcastle Human Embryonic Stem Cell Group that was granted the license. "The potential this area of research offers is immensely exciting, and we are keen to take the work we've done so far to the next level."
Three months after the Newcastle group first announced its application, the HFEA's Licence Committee granted just a 1-year license, allowing researchers to create stem cells from human ova for research purposes only.
"This is an important area of research and a responsible use of technology," said HFEA chief Suzi Leather. "The HFEA is there to make sure any research involving human embryos is scrutinized and properly regulated."
The fact that the license is only for 1 year was surprising, said Stephen Minger, a stem cell researcher from King's College London. "I think the HFEA is being cautious here," he told The Scientist. "They're feeling their way along."
Chris O'Toole, head of research regulations at HFEA, said the 1-year limit was imposed because this was "a novel license, and we felt that in the first instance it should only be for a year." The Newcastle group could apply for a further 3-year license if everything goes well in the first year, she told The Scientist. The progress of the project would be assessed after 6 months, and the researchers could reapply about 9 months into the first year.
Minger didn't think there was much chance of the license not being renewed after the initial year. "These guys [in Newcastle] have the experience to do this sort of thing," he said. "They're highly competent people and more than qualified to do it."
The group's license allows them to undertake cell nuclear replacement using nuclei from existing stem cell lines and using nuclei from skin cells taken with informed consent from women undergoing gynecological procedures. The initial application also included a third activity, but the Newcastle group withdrew this request after HFEA sought additional information about it. O'Toole said they might seek an extension of the license to undertake this activity—which HFEA would not give details of—at a later date.
In some ways, Minger said, the fact that the HFEA deliberated so hard before making a decision on a 1-year license is a sign that the United Kingdom has got its cloning and stem cell laws right. "People think long and hard about these things, and that's the kind of country you want to be doing this sort of research in," he said.
In the United Kingdom, reproductive cloning is illegal, and research on human embryos is only allowed for certain purposes. The original rules were set by the Human Fertilisation and Embryology Act (1990), which allowed the HFEA to grant licenses if the use of human embryos was to help treat infertility, increase knowledge about the causes of congenital disease, improve understanding of miscarriages, or develop better contraception or find ways to detect the presence of gene or chromosome abnormalities.
In 2001, new regulations allowed embryo research for increasing knowledge about the development of embryos, improving understanding of serious disease, or enabling such knowledge to be applied in developing treatments for serious disease.
Murdoch and her colleague Miodrag Stojkovic stressed that their work was a long way from providing treatments, and Minger agreed. "In reality, this doesn't bring us much closer to the clinic," he said. "We still have to figure out how to turn these stem cells into clinically useful cells."
The decision was not welcomed by all. Life, a pro-life charity, deplored the announcement. "Even though the HFEA has not granted all that was requested, this is a deplorable further step down the slippery slope. We should be ashamed of it," said Life's National Chairman, Jack Scarisbrick.
Human Genetics Alert, an anti-cloning group, also condemned the decision. David King, the group's director, said the move was designed to influence the United Nations, which is debating an international treaty on cloning, not to ban this type of research. "The research will have no scientific or medical benefit and is cruelly raising people's hopes," he said.
References
| 1. | | [http://www.hfea.gov.uk/PressOffice/Archive/1092233888]
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| | | "HFEA grants the first therapeutic cloning licence for research," Human Fertilisation and Embryology Authority press release, August 11, 2004. Return to citation in text:
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| 2. | | [http://www.the-scientist.com/news/20040616/02/]
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| | | S. Pincock, "UK considers cloning request," The Scientist, June 16, 2004. Return to citation in text:
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| 3. | | [http://www.kcl.ac.uk/depsta/biomedical/cfnr/members/minger.html]
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| | | Stephen Minger Return to citation in text:
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| 4. | | [http://www.centreforlife.co.uk/news/article.php?id=15]
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| | | "Application for a licence to undertake research involving somatic cell nuclear transfer," Centre for Life press release, May 10, 2004. Return to citation in text:
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| 5. | | [http://www.lifeuk.org/news/news.php?subaction=showfull&id=1092229154&archive=&start_from=&ucat=&]
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| | | "Life deplores HFEA go ahead on cloning," Life press release, August 11, 2004. Return to citation in text:
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| | | Human Genetics Alert Return to citation in text:
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| 7. | | [http://www.the-scientist.com/news/20031210/05/]
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| | | T. Tamkins, "UN to vote on cloning in a year," The Scientist, December 10, 2003. Return to citation in text:
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