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NIH issues guidelines for human stem cell research.

On August 25, after nine months of sorting through approximately 50,000 comments, NIH issued final guidelines for federally funded research utilizing human pluripotent stem cells derived from human embryos and fetal tissue. The NIH Health Guidelines for Research Using Human Pluripotent Stem Cells lay out a set of procedures to ensure that any NIH-funded research is conducted in an ethical and legal manner. The rules drew praise from the scientific community, which has thus far relied strictly on the private sector for funds, and condemnation from some policymakers and antiabortion activists who view the ruling as a flagrant circumvention of a 1996 ban on human embryo research.

Pluripotent stem cells have the ability to grow into nearly any element of the human body, and scientists see research in this area as an opportunity to discover treatments for conditions and diseases such as Alzheimer's, Parkinson's, diabetes, and spinal cord injuries.

Shortly after the guidelines were issued, a coalition of more than 65 patient, health, and scientific advocacy groups and universities issued a statement strongly supporting NIH's ruling. "Stem cell research offers one of the most promising avenues to finding a cure for my daughter and for all children with life-threatening disease," said Lyn Langbein, mother of a five-year-old child with diabetes, in the statement, which was issued by the American Society for Cell Biology.

Lawmakers including Sen. Sam Brownback (R-Kan.) and Rep. Jay Dickey (R-Ark.), who oppose the NIH guidelines, view the research as unethical, unnecessary, and immoral and argue that the derivation of embryonic stem cells is the same as the dismembering of a human being.

Though NIH may fund research using stem cells, its guidelines do not allow the use of federal dollars to derive the stem cells, a process in which a human embryo is destroyed and which is illegal under the 1996 ban. Derivation of embryonic stem cells must remain strictly in the private sector. In addition, NIH restricted the source of embryos that the private sector may use to obtain stem cells to those created for use in fertility treatment. The embryos must be frozen and in excess of clinical need. No financial inducement may be offered for donating them to research. Couples seeking fertility treatment can be given informed consent agreements to donate their excess embryos only after they have decided to discontinue fertility treatments.

NIH set these conditions in order to separate the decision-making process of providing embryos for fertility treatment from the donation of embryos for research. In addition, they are designed to protect against the creation of a commercial market for harvesting embryos. As an added precaution, NIH will establish the NIH Human Pluripotent Stem Cell Review Group to review research proposals and compliance with the guidelines and to hold public meetings to review proposals. The new group also will be given the authority to recommend revisions to the NIH guidelines.

Other areas not eligible for NIH funding include research utilizing stem cells to create a human embryo, research in which stem cells were derived by means of somatic cell nuclear transfer (the technique used to clone Dolly the sheep), research that would combine a human stem cell with an animal embryo (creating a chimera), and combining stem cells with somatic cell nuclear transfer for the purpose of reproductive cloning of a human being.
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Title Annotation:National Institutes of Health
Publication:Issues in Science and Technology
Article Type:Brief Article
Geographic Code:1USA
Date:Dec 22, 2000
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