The U.S. National Institutes of Health (NIH) released today a new set of official guidelines for "human pluripotent stem cells" (hPSC) research. These guidelines are conditions that medical researchers, both domestic and foreign, must meet in order to obtain NIH funding for human stem cell research. The complete guidelines are posted on their Web site at http://www.nih.gov/news/stemcell/stemcellguidelines.htm
Some highlights:
To ensure that the donation of human embryos in excess of the clinical need is voluntary, no inducements, monetary or otherwise, should have been offered for the donation of human embryos for research purposes. (Translation: researchers can't buy embryos from anyone.)
The attending physician responsible for the fertility treatment and the researcher or investigator deriving and/or proposing to utilize human pluripotent stem cells should not have been one and the same person. (Translation: fertility doctors can't create a conflict of interest by researching embryos they themselves have created for fertility treatment.)
Only frozen human embryos should have been used to derive human pluripotent stem cells. In addition, individuals undergoing fertility treatment should have been approached about consent for donation of human embryos to derive pluripotent stem cells only at the time of deciding the disposition of embryos in excess of the clinical need. (Translation: Aborted embryos can't be used.)
Informed consent should have included:
- A statement that derived cells and/or cell lines may be kept for many years;
- Disclosure of the possibility that the results of research on the human pluripotent stem cells may have commercial potential, and a statement that the donor will not receive financial or any other benefits from any such future commercial development; (Translation: donors can't sue research companies for profits that result from their research.)
- A statement that embryos donated will not be transferred to a woman's uterus and will not survive the human pluripotent stem cell derivation process. (Translation: A donor's embryos won't be allowed to grow into a baby after research is done.)
Areas of research ineligible for NIH funding include:
- Research in which human pluripotent stem cells are utilized to create or contribute to a human embryo; (Translation: no living people will be made from any whole or partial donations.)
- Research utilizing pluripotent stem cells that were derived from human embryos created for research purposes, rather than for fertility treatment; (Translation: embryos have to come from donors, not from scientists.)
- Research in which human pluripotent stem cells are combined with an animal embryo; (Translation: no "Dr. Moreau" experiments.)
- Research in which human pluripotent stem cells are used in combination with somatic cell nuclear transfer for the purposes of reproductive cloning of a human. (Translation: These embryos are intended primarily for transplant research. Cloning is still verboten.)
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