With Good Reason The New Guidelines for Stem Cell Research

Jul 14, 2009

In the course of deliberations at the Empire State Stem Cell Board, my colleagues and I have discussed "ethical" guidelines that would ideally govern everything from obtaining informed consent for the "donation" of human gametes or already existing embryos for research purposes to "respect" for the human embryo in the laboratory setting.  In the course of those exchanges, I have often had the unpleasant sensation of partaking in something akin to a debate over what color to paint the 'shower' stalls at Auschwitz.   In New York State, embryo-destructive research is legal and fundable by the state as long as it is engaged in "ethically."

This of course reflects the sad reality that our federal government has vouchsafed a medical and scientific regime that warrants the destruction of "unwanted" IVF embryos for research purposes.  This is nowhere more apparent than in the recently released National Institutes of Health (NIH) Guidelines on Human Stem Cell Research which went into effect on July 7.

Readers will recall that on March 9, 2009, President Obama issued Executive Order 13505, "Removing Barriers to Responsible Scientific Research Involving Human Stem Cells." The executive order directed the Secretary of Health and Human Services, through the NIH, to "support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell (hESC) research, to the extent permitted by law" and to develop appropriate guidelines governing the distribution of federal funds to hESC researchers.  The NIH is, of course, the great financial umbilical cord supplying U.S. tax-payer dollars to fund the vast majority of biomedical researcher in our country. So, the promulgation of these guidelines has been no small issue of late: how would the new guidelines impact hESC research that was already underway and how would they impact that research in the future?

On April 23, 2009 the NIH first published a draft of the proposed Guidelines and allowed for some thirty days of public comment, a period which ended on May 26, 2009 and garnered some 49,000 comments. 

So what to make of the final product?  The guidelines are, first and foremost, tragic: they enshrine a federal fiat for treating "unwanted" human embryos, discarded after their creation for reproductive uses in assisted fertility clinics, as raw material for human embryonic stem cell research.  That said, we can nonetheless be grateful that the NIH exercised a considerable degree of restraint in determining what the guidelines would prohibit, render more difficult or frown upon. Here some highlights:

• The guidelines do not allow federal funding of research on human embryonic stem cell lines derived from embryos created specifically for research purposes (only on embryos created for reproductive purposes and then subsequently "donated" for research purposes), nor do they allow funding for research on embryos created by SCNT (cloning) or parthenogenesis.  
• The guidelines require that embryo "donors" give express written consent when they give up their embryos for research (even if they had given prior consent) and that researchers demonstrate that they had informed donors of their right to rescind consent up to the point that the embryos would be destroyed in research or de-identified.
• The guidelines clearly define human embryonic stem cells as cells derived from "blastocyst stage human embryos." Some critics wanted the disturbing word "embryo" to be eliminated from the definition.
• The guidelines do not allow for the federal funding of the process by which the embryos are actually destroyed in the lab and the hES cells are derived, as this is prohibited by the Dickey-Wicker Amendment. (Of course, they nonetheless encourage such destruction, and once completed, the federal dollars will be available for research).
• Finally, the guidelines are negative on techniques (like cloning and parthenogensis) which require females to undergo ovarian stimulation for the retrieval of their eggs describing such a procedure as one that "has health and ethical implications, including the health risk to the donor from the course of hormonal treatments needed to induce oocyte production."  

Proponents of embryo-destructive research will doubtless cry foul at the NIH's exercise of reserve in establishing these guidelines.  As for the rest of us, while we can be grateful for the agency's restraint, we can hardly call this a pro-life victory.

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