Published online 26 May 2009 | Nature | doi:10.1038/news.2009.515
Updated online: 27 May 2009

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Draft stem-cell guidelines criticized

Researchers complain that previously approved cell lines would not be covered.

As the National Institutes of Health (NIH) begins finalizing guidelines to govern US funding of human embryonic stem-cell research, an initial ripple of researcher worry has swollen into a near-unanimous wave of concern that virtually all existing stem cell lines would be disqualified if the draft guidelines were adopted as written, with their strict informed-consent provisions.

During the 30-day period of public comment on the guidelines that ends today (26 May), the NIH received tens of thousands of comments. Although a large number came from religious conservatives opposed to any expansion of federal funding for the research, scientists' concerns centred on the fate of existing research.

More than 700 human embryonic stem-cell lines are thought to exist worldwide.Alamy

"If adopted as written — and we don't think they will be — [the guidelines] would make it virtually impossible for any lines that exist now to be eligible for federal funding," says Amy Comstock Rick, president of the Coalition for the Advancement of Medical Research, an umbrella group of disease organizations, scientific societies and universities that supports stem-cell research.

The NIH has estimated that more than 760 human embryonic stem-cell lines exist at banks and registries globally. In August 2001, former President George W. Bush said that the government would fund research on only a score of lines available at the time. "Even an initial analysis of the 21 NIH-approved cell lines shows that the vast majority would not be available for NIH funding under a strict interpretation of the draft NIH guidelines," says George Daley, a stem-cell researcher at Children's Hospital Boston. "Hopefully the NIH will revise their draft to grandfather in the hundreds of existing lines that have been derived under the highest standards of their time."

In March, President Barack Obama lifted the Bush restrictions and asked the NIH to work out the details for proceeding with the funding of "scientifically worthy and responsibly conducted research". When the NIH announced its draft guidelines on 17 April, acting director Raynard Kington told reporters he was confident that they would "greatly expand" the number of stem-cell lines available. But as scientists and advocates have parsed the provisions, they have found many devils in the details.

Consent needed

Much of their concern lies within nine provisions that the guidelines say must be included in informed consents signed by patients who donate embryos left over after in vitro fertilization (IVF). For instance, the consent form must spell out that the donation is being made "without any restriction or direction" regarding the use of the stem cells or the patients who may benefit from the research. It must stipulate that the donors "would not receive financial or any other benefits" from commercial development of the research.

Many existing informed consent forms do not include such provisions, says Patrick Taylor, deputy general counsel for research affairs at Children's Hospital Boston. What's more, he says, there are legitimate arguments against including them, and no general consensus on their appropriateness. Taylor published a recent critique on the hazards of retroactive ethical rules, and of the NIH's stem-cell guidelines in particular.1 Other provisions in the draft guidelines enjoy broad ethical agreement, such as voluntary, uninduced consent, and telling donors what will happen to the embryos in the process of stem-cell derivation.

Another stipulation for existing lines requires federally funded researchers to document that donors' decisions were made free from researcher influence. Taylor and others have interpreted this to mean that IVF clinics must have an explicit written policy, or a statement in their informed consents, to this effect. However, the vast majority of IVF clinics have no regular relationship with researchers, and thus are unlikely to have written policies or consent forms addressing the issue.

In their comments, researchers are also urging the NIH to create a registry of stem-cell lines that qualify for federal funding under whatever guidelines are finally adopted. Otherwise, says Comstock Rick, an "incredibly inefficient" system could result, with each university having to do due diligence on each stem-cell line its federally funded researchers want to use.

There is also discontent that the NIH did not allow federal funding for research on stem cells that may one day be derived from embryos created by somatic cell nuclear transfer, or from embryos created by IVF for research purposes. Groups including the CAMR and the Association of American Medical Colleges urged the NIH to reconsider on this point.

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As for concerns that the NIH guidelines could keep US researchers from using lines derived under different consent procedures in countries such as the United Kingdom, Peter Braude, an expert in stem-cell derivation at St Thomas' Hospital in London, is sanguine. Authorities on both sides of the Atlantic, he says, "will try to avoid [mismatches] and get to some kind of sensible international consensus".

Whatever changes it adopts, the NIH will need to do so quickly: once they are drafted, the final guidelines must still win approval from senior officials in the office of the Secretary of Health and Human Services and at the Office of Management and Budget before the publication deadline of 7 July. 

Updated:

As of midday on 27 May, the NIH had received more than 48,000 comments on the draft guidelines.

  • References

    1. P. Taylor, Cell Stem Cell doi:10.1016/j.stem.2009.05.002; 2009.
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