Administration unveils stem cell rules

The federal government can begin approving funding for research on a greatly expanded number of embryonic stem cells as of Tuesday under guidelines announced by the National Institutes of Health (NIH).

Federal dollars will be available for research on human embryonic stem cells that were derived from leftover embryos created for reproductive purposes at in vitro fertilization clinics and only with the donors’ consent. Funding is prohibited for stem cells created any other way.

“We believe that the final guidelines we are releasing today adhere to both of President Obama’s principles” that the NIH advance stem cell research but do so in an ethical way, acting NIH Director Raynard Kington said Monday.

With the NIH’s announcement, Obama is now able to fulfill his campaign promise to significantly increase research in this area, which is seen as highly promising by scientists seeking treatments for a plethora of ailments.

The Obama administration’s actions Monday are sure to reignite the smoldering debate over the morality and ethics of embryonic stem cell research.

Though scientists covet these stems cells because of their potential to be transformed into virtually any human tissue — which could lead to cures for diseases as diverse as cancer and Alzheimer’s — human embryos must be destroyed in the process of their creation.

The fault line in the political debate over stem cell research is mostly, though not entirely, the same one that separates supporters and opponents of abortion rights.

The NIH witnessed this emotional intensity firsthand. The agency received more than 49,000 comments from the public after issuing a draft of its guidelines in April. About 30,000 of them — many of which were form letters — debated whether the NIH should be funding embryonic stem cell research at all, Kington said.

The NIH disregarded all such comments, labeling them “unresponsive” to the guidelines it released. “We actually did not ask the public whether we should fund research on human embryonic stem cells. We asked the public how we should fund human embryonic stem cell research,” Kington said.

An executive order Obama issued in March, combined with the NIH guidelines issued Monday, freed up the agency to begin funding research on more embryonic stem cells right away.

“We clearly predict that the opportunities for research will greatly expand,” said Kington. The new NIH funding from the stimulus bill enacted earlier this year, combined with the expectation of a change in stem cell funding policy, prompted numerous applications that are pending, he said. The NIH gave out $88 million in research grants on embryonic stem cells in fiscal 2009, according to Kington.

Nevertheless, legislation is still pending in Congress to further expand on the parameters for that research. President George W. Bush twice vetoed previous versions of the bill.

Obama’s executive order lifted strict limits on embryonic stem cell research put in place by Bush. The Bush policy permitted federal funding on only embryonic stem cells created before Aug. 9, 2001.

“Today, with the executive order I am about to sign, we will bring a change that so many scientists and researchers, doctors and innovators, patients and loved ones have hoped for, and fought for, these past eight years: We will lift the ban on federal funding for promising embryonic stem cell research,” Obama said at the time.

Obama gave the NIH a wide berth in developing its guidelines for what types of embryonic stem cells would be eligible for federal funding.

That leeway led to concern among opponents, and some supporters, of embryonic stem cell research that federal dollars would go to finance studies using stem cells derived from even more controversial means than in vitro fertilization for reproductive purposes.

But the final guidelines, building on a draft issued in April, only permit funding on leftover embryos and establish standards for informed consent of the donors. The rules also prohibit clinics from providing any type of inducement, financial or otherwise, in exchange for donors consenting to scientific research on their embryos.

Some scientists wanted the NIH to fund research on other methods of deriving embryonic stem cells in settings other than fertility clinics, but the agency declined. “We don’t believe there’s been the public discussion” about the ethical or scientific implications of other methods, Kington said.

The NIH policy does not change current federal law strictly forbidding the creation of human embryos expressly for scientific research.

To qualify for NIH funding under the Obama policy, researchers have to substantiate that the cells they propose to use were developed under the NIH’s ethical standards, particularly the rules for informed consent of donors. Researchers who used other methods of informed consent, or cells derived in foreign countries, must submit documentation to an NIH panel to obtain approval.

Once the NIH approves a stem cell line, it will be placed on a registry, after which any researcher may access federal money to work on those lines.