Congress gets a chance to codify sensible NIH rules for stem cell research.

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Saturday, October 10, 2009

THE SWIRL of controversy that greeted President Obama's executive order lifting the ban on federal funding of stem cell research in March didn't make a significant return when the final rules were released over the summer. That's because the National Institutes of Health successfully navigated a minefield of ethical and moral questions. To protect those regulations from politics and changes by another administration, Rep. Diana DeGette (D-Colo.) soon will introduce the Stem Cell Research Enhancement Act of 2009. The legislation would codify Mr. Obama's executive order permitting federal funding of such research within guidelines established by the NIH and would require that they be reviewed periodically.

Usually, couples who go to in vitro fertilization clinics create more embryos than will be implanted. The remainder are either destroyed or frozen. The NIH regulations and the bill would allow couples to donate their embryos for research as long as they are fully informed of their choices and they are not compensated for the embryos. The guidelines give donors the ability to change their minds "until the embryos were actually used."

Mr. Obama's executive order overturned one issued by President George W. Bush in 2001 that allowed federal funding only for those stem cell lines already developed. Scientists ultimately found the number of approved lines too few and the utility of those lines limited.

For facilities with stem cell lines developed on or before July 7, the NIH will establish a committee of scientists, ethicists and advocates to examine on a case-by-case basis the procedures and paperwork to determine whether the lines were derived with voluntary informed consent from donors and in a manner consistent with the new rules. This panel would also make the same evaluation of stem cell lines originating outside the United States. There are an estimated 700 stem cell lines already in existence.

The bill specifically outlaws human cloning, as do the NIH guidelines. And Congress already prohibits federal funding for collecting stem cell lines from human embryos, which are destroyed in the process. But the NIH rules make it clear that taxpayer money will not be used on lines from embryos created solely for research. The life-saving treatments and therapies that could result from stem cell research should not come from crossing this clear moral and ethical boundary.


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