National Institutes of Health issues final embryonic stem cell guidelines
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Washington D.C., Jul 6, 2009 / 05:04 pm 
(<http://www.catholicnewsagency.com>CNA).- The National Institutes of 
Health (NIH) has released its final guidelines for human embryonic 
stem cell research. The rules allow the funding of research which 
uses stem cells harvested from fertility clinic embryos and also 
outline informed consent standards for women or couples who donate 
their embryos.

The guidelines, which implement a March 9 executive order issued by 
President Barack Obama, become effective July 7.

Msgr. David Malloy, General Secretary of the U.S. Conference of 
Catholic Bishops (USCCB), has been critical of the NIH rules. In a 
May commentary on the guidelines, he said the rules were "broader or 
more permissive" than any previous research policy in key respects.

He also insisted it was a human right not to be subjected to harmful 
experimentation.

"As the President noted," Msgr. Malloy said, "we must not make 'a 
false choice between sound science and moral values.' In fact, these 
sources of guidance both point in the same direction, away from 
destructive embryonic stem cell research. His executive order and 
these Guidelines nonetheless insist on a course of action that is 
both morally objectionable and, increasingly, scientifically obsolete."

"This is not merely a political or ideological problem, or a problem 
of religious dogma, but a deeply human problem: We are testing the 
limits of our obligation to treat all fellow human beings, of every 
age and condition, with basic respect," Msgr. Malloy wrote.

There was doubt about whether the new NIH requirements for informed 
consent would have disqualified some existing stem cell lines, the 
Associated Press says. The NIH now requires documentation of 
voluntary informed consent from a woman or couple who donate the 
original embryo. They must have been told of other options for 
"leftover" embryos, such as donating to another infertile woman.

The NIH designed a compromise which deems old stem cell lines 
eligible for government research dollars if scientists can prove they 
met the spirit of the new ethics standards.

An NIH registry will list all cell lines that qualify.

Acting NIH Director Raynard Kington portrayed the informed consent 
guidelines as a "reasonable compromise" which will achieve President 
Obama's stated goal of "advancing science while maintaining rigorous 
ethical standards," the Associated Press reports.

Stem cell research hopes to harness the power of adult or embryonic 
stem cells to create better treatments for ailments ranging from 
diabetes to spinal cord injuries. Embryonic stem cells are harvested 
by destroying human embryos.

NIH-STEMCELLS Jul-6-2009 (430 words) With photo posted April 21. xxxn

NIH rejects comments opposing funding of embryonic stem-cell research

By Nancy Frazier O'Brien
<http://www.catholicnews.com/index.html>Catholic News Service

WASHINGTON (CNS) -- Although 30,000 of the approximately 49,000 
comments on the National Institutes of Health's draft guidelines on 
human embryonic stem-cell research opposed any federal funding of 
such research, those responses were "deemed not responsive to the 
question put forth," according to the acting director of NIH.

"We did not ask them whether to fund such funding, but how it should 
be funded," said Dr. Raynard S. Kington in a telephone briefing with 
the media July 6.

But Richard M. Doerflinger, associate director of the U.S. bishops' 
Secretariat of Pro-Life Activities, said it was "disingenuous (for 
Kington) to say that comments criticizing the guidelines overall were 
to be ignored."

The 30,000 individuals or organizations that made comments in 
opposition to federal funding of embryonic stem-cell research were 
saying, "You're not responding to what the American people want. 
Start over," Doerflinger added.

The U.S. Conference of Catholic Bishops and its affiliated 
organization, the National Committee for a Human Life Amendment, 
directed 9,436 comments to NIH about the draft guidelines before the 
May 26 close of the public comment period, according to Deirdre A. 
McQuade, assistant director for policy and communications in the 
pro-life secretariat.

NIH's final guidelines, which take effect July 7, are not 
significantly different from the draft guidelines published April 23 
and open for public comment until May 26.

The draft guidelines allowed the use of federal funds for embryonic 
stem-cell research only on embryos created for reproductive purposes 
at in vitro fertilization clinics and no longer needed for that 
purpose. They set standards for voluntary informed consent by those 
donating the embryos, and said no NIH funds would be given for 
research that did not meet the standards.

The final guidelines, however, set up an "alternative pathway" for 
approval of funding of research involving embryos donated before the 
new guidelines took effect. A working group made up of about 10 
scientists and ethicists will look at each such application on a 
case-by-case basis, Kington said, to determine whether it meets "the 
core principles of voluntary informed consent."

Like the draft, the final guidelines specifically ban funding "for 
research using embryonic stem cells derived from other sources, 
including somatic cell nuclear transfer, parthenogenesis and/or IVF 
embryos created for research purposes."

Also prohibited is funding of research in which stem cells "are 
introduced into nonhuman primate blastocysts" or research "involving 
the breeding of animals where the introduction of human 
embryonic-stem cells or human-induced pluripotent stem cells may have 
contributed to the germ line."

MORE TO COME
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