by Bryn Nelson

Some think the US should adopt a UK regulatory structure for embryo research

Officials at the US National Institutes of Health (NIH) will be kept busy for the next four months as they craft new guidelines specifying which embryonic stem (ES) cell research will now qualify for federal funding. But that hasn't stopped the first rumblings of a fight over what the country's regulatory framework might eventually look like.

President Obama's executive order does not overturn the Dickey–Wicker Amendment, a 13-year-old ban on federal funding for the actual creation of new stem cell lines, an act that destroys an embryo. In the United States these efforts must be funded privately or by state governments.

Ruth Macklin, a professor of bioethics at Albert Einstein College of Medicine in New York, is among those who support a regulatory agency patterned after the UK's Human Fertilisation and Embryology Authority, in existence since 1990. The HFEA oversees the creation, storage and use of embryos for research, and regulates fertility clinics. Beyond laying out enforceable rules for ES cell science in the United States, she says, a similar scheme would bring order to the largely unregulated in vitro fertilization (IVF) industry.

"We have been involved in pushing for not doing something like that," responds Amy Comstock Rick, president of the Coalition for the Advancement of Medical Research based in Washington, DC. "We have the National Institutes for Health and they have the authority and the expertise to issue guidelines in this area, and in fact they did that before Bush issued his policy."

The country's scientific advisers, the National Academies, have already issued ethical guidelines about when hES cells can be used for research, and Comstock Rick notes that university-based ES cell research already has to pass muster with institutional oversight committees to ensure the experiments are conducted responsibly.

Advocates of a British-style plan say the current system lacks cohesiveness and transparency. "I think it should be looked at very seriously as a model, and I've been saying this since 2002 when I was first licensed by the HFEA to derive human embryonic stem cell lines," says Stephen Minger, director of the Stem Cell Biology Laboratory at King's College London. Crucially, he says, the UK regulations make no distinction between private and federal funding or between private and public IVF clinics.

But Comstock Rick counters that following the UK approach would add a counterproductive "parallel layer" of regulation that would largely duplicate the existing framework. "This country already has an amazing infrastructure in place to deal with these issues," she says, "and we think it should be used, and could be used, very well."

Regardless of how the regulatory apparatus is conceived, officials may face another major ethical scuffle if Congress eventually allows federal funding for the derivation of new stem cell lines. The Vatican, a fierce opponent of ES cell research, recently fired another shot across the bow of US policymakers by reiterating its opposition to IVF — the estimated 400,000 frozen embryos stored at IVF clinics across the country are the main source for deriving new ES cell lines in the United States.

Scientists have noted that cloning embryos for therapeutic purposes will require donated eggs as well, raising the additional conundrum of how to ethically secure donations from healthy women. As demonstrated by the opposition of feminist groups in countries such as Germany, both researchers and bioethicists say that ambivalence towards ES cell research on those grounds can't be ignored — or underestimated.

 

Source:  Nature

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