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AAAS Response to Draft NIH Human Stem Cell Research Guidelines Calls for Reconsideration of Three Issues

Federal funding for research involving stem cells derived from donated, excess human embryos from fertility treatments "will provide an opportunity to achieve important progress," the AAAS said in a 20 May comment on draft National Institutes of Health guidelines on human stem cell research.

Further, AAAS is "pleased to see NIH move quickly to issue guidelines that will enable scientists to move forward in this crucial field," AAAS chief executive officer Alan I. Leshner noted in his comment letter on behalf of AAAS.

But the AAAS letter also raised several concerns related to informed consent rules, a federal registry of stem cell lines, and the challenges of conducting public and private research within the same facility.

The draft NIH guidelines were published in the Federal Register 23 April 2009, shortly after President Barack Obama in March lifted restrictions set forth in 2001 by his predecessor, George W. Bush. The new president's decision was hailed as an end to the long-standing ban on federal funding to support any newly developed human embryonic stem cell lines. But Obama emphasized the need for the NIH to develop stringent ethical guidelines.

In his letter of comment, Leshner, who is also executive publisher of Science, wrote that NIH should consider a strategy to "grandfather in" existing stem cell lines that were developed in accordance with all known ethical guidelines—though before current rules regarding informed consent were put into place.

Obtaining voluntary consent from donors is an essential ethical safeguard, AAAS emphasized. But "it is unclear how many of the lines used in ongoing studies would be in compliance with the new guidelines," Leshner wrote. "Reconsent may be an impractical burden on researchers, leading some to forgo promising research."

AAAS also urged NIH to maintain a stem cell registry to keep scientists informed of eligible lines.

Finally, AAAS noted that administrative strings tied to federal funding would make it difficult or impossible for researchers receiving both public and private support to share equipment and laboratory space. In such cases, costs inevitably would skyrocket to support separate facilities and research projects.

The AAAS letter calls for further exploration of the "administrative, legal and ethical solutions to the problems inherent in the separation of public and private research."

AAAS has long emphasized the need for strong ethical guidelines governing federal support for human embryonic stem cell research. In 1999, for instance, the association issued a report on Stem Cell Research and Applications .

The complete text of Leshner's letter is available here.