By Susan Brinkmann, OCDS
Staff Writer

The National Institutes for Health (NIH) published their official guidelines today regarding human embryonic stem cell research after admitting that they disregarded 30,000 of the approximately 49,000 comments received during the public comment period because they were deemed to be “not responsive to the question put forth.”

During a telephone briefing with the media on July 6, Dr. Raynard S. Kington of the NIH said about the rejected comments: “”We did not ask them whether to fund such funding, but how it should be funded.” Therefore, the comments were thrown out.

But Richard M. Doerflinger, associate director of the U.S. bishops’ Secretariat of Pro-Life Activities, told the Catholic News Service that 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 said.

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

However, one major area of difference between the draft and final version of the guidelines involves the area of consent. 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 that were no longer needed for that purpose, and for which there was voluntary informed consent by the parents of those embryos. This applied to embryos created as long as 10 years ago, a requirement many researchers complained would greatly reduce the number of available stem cell lines.

The new guidelines addressed this issue by setting up an “alternative pathway” for approval of funding for research on these older embryos. This pathway consists of a group of scientists and ethicists who will work on a case-by-case basis to determine whether “the core principles of voluntary informed consent” are being met.

Another area of concern in the final version of the guidelines also involves consent. Previously, parents of unused IVF embryos had to be told of all options for their embryos before giving consent for their use in embryo-destructive research. Now parents only need to be told about options available at the particular clinic. So if that clinic is not involved in embryo adoption or otherwise bringing unused embryos to term, the parents don’t need to be told about those options.

Anyone applying for NIH funding for research on embryonic stem cells derived after July 7, 2009, must apply for grants and submit support that the embryos were derived following the NIH’s ethics standards.

Among the requirements:

• There must be a “clear separation” between the decision to create embryos for reproductive purposes and for research purposes

• Medical personnel at the in vitro fertilization clinic must explain to the donor all other options pertaining to embryos that are no longer needed

• Donors cannot be paid or given other financial inducements to donate embryos

• Research cannot provide direct medical benefit to the donor (such as creating stem cells that would then be used to treat the donor’s own disease)

• The clinician creating embryos during in vitro fertilization cannot also perform research on them

Like the draft, the final guidelines specifically ban funding “for research using embryonic stem cells derived from other sources, including somatic cell nuclear transfer [otherwise known as cloning], 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.”

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