After President Obama lifted the restriction on federal funding of human embryonic stem cell research, the NIH was charged with developing guidelines as to which embryonic stem cell lines will be eligible for funding and which will not. The NIH published a draft of these new guidelines last week.The 2009 NIH guidelines are surprisingly conservative. And here is why. Because of the Dickey-Wicker Amendment, which prohibits federal funding of research on human embryos, NIH funds can only go to research on the embryonic stem cell lines themsleves. Federal funds cannot go to the actual creation of the embryonic stem cell lines (ESC) because that violates the Dickey Amendment. The creation of the embryonic stem cell lines have to be performed elsewhere because the derivation of ESC lines destroys human embryos.
So the NIH is faced with which embryonic stem cell lines to fund. Embryonic stem cell lines can be derived from embryos "leftover" from infertility treatments, embryos that were created with egg and sperm especially for research, or (theoretically) from embryos created by somatic cell nuclear transfer better known as cloning. With previous funding restrictions lifted, the NIH draft could have funded research on ESC lines from any of the above sources including lines derived from embryos specifically created for research.
Fortunately, it did not. The NIH guidelines have restricted federal funds to embryonic stem cell lines that were derived from "left-over" IVF embryos only. The guidelines state:
Eligibility of Human Embryonic Stem Cells Derived from Human Embryos: Human embryonic stem cells may be used in research using NIH funds, if the cells were derived from human embryos that were created for reproductive purposes, were no longer needed for this purpose, were donated for research purposes, and for which documentation for all of the following can be assured:
1. All options pertaining to use of embryos no longer needed for reproductive purposes were explained to the potential donor(s).
2. No inducements were offered for the donation.
3. A policy was in place at the health care facility where the embryos were donated that neither consenting nor refusing to donate embryos for research would affect the quality of care provided to potential donor(s)....
And the list of qualifications goes on. So, for now, federal funds would only go to ESC lines that were derived from embryos created for reproductive purposes only and not from embryos create specifically for research.
Unfortunately, I do not believe this restriction is long for this world. Why? Well if you had a choice between leftovers and something cooked fresh just for you which would you choose?
Scientists are no different. They want to work on ESC lines created all different kinds of ways, not just from "cast-offs" of the fertility industry. Already some scientists are expressing their disappointed at the proposed limitations. From Nature.com:
Disappointing some researchers, the guidelines explicitly disqualify from funding any stem cell lines derived from embryos created for research purposes, whether by standard IVF methods or by somatic cell nuclear transfer....
Mark Kay, a geneticist and stem cell researcher at Stanford University in Palo Alto, California, said he would have liked to see the guidelines embrace stem cells derived outside the reproductive context. Still, he says, the draft effort "is a step in the right direction".
Meri Firpo, who uses stem cells in diabetes research at the University of Minnesota, called the guidelines "reasonable", but added that "there are some specific issues that probably need clarifying". Among them, she said, is the guidelines' silence on whether lines derived from embryos created from donated sperm or ova would qualify — under guidelines adopted in the past by the US National Academies, they do not qualify. Firpo, who derives stem cell lines, says that to comply with the Academies' guidelines, she has had to turn away offers of embryos because sperm or egg donors were used for their creation.
These guidelines are just a draft and the NIH has asked for public comments. I have no doubt scientists and pro-embryonic stem cell activists are criticizing any limitations. The NIH wants your opinion:
The NIH welcomes public comment on the draft Guidelines. Comments must be submitted within 30 days of publication of the Guidelines in the Federal Register. The Guidelines are expected to be published in the Federal Register by April 24th. Comments may be mailed to: NIH Stem Cell Guidelines, MSC 7997, 9000 Rockville Pike, Bethesda, Maryland, 20892-7997. At the time of publication in the Federal Register, the NIH will make available a URL where comments may be submitted electronically. In submitting comments, please note that comments will be made publicly available, including any personally identifiable or confidential business information they contain.
It is your money. Tell them how you want it spent.
