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Draft Guidelines Published for Stem Cell Research

WASHINGTON, D.C. · December 15, 1999 · by TNN Medical Reporter Virginia Baskerville

The National Institutes of Health (NIH) has issued draft guidelines for research involving human embryonic stem cells.

The draft guidelines were published on December 2 in the Federal Register, at which time a 60-day comment period began. The NIH said that it will not fund research involving the cells, also called human pluripotent stem cells, until final guidelines are published and an oversight process is in place.

In recognition of the ethical, legal, and social issues that have surrounded the idea of conducting research using the stem cells, the NIH characterized the guidelines as more stringent than the typical NIH peer review process. Since two groups of scientists announced in November 1998 that they had isolated such cells, their potential use has proven controversial, in part, because the cells are taken from aborted fetuses or embryos that were created for in vitro fertilization.

However, the stem cells, which can give rise to virtually any type of human cell, have also been heralded for their enormous potential to treat a wide range of diseases and conditions. The draft guidelines say that one potential use is to "generate cells and tissue that could be used for transplantation."

In part, the guidelines describe conditions that should be met before NIH funds are used to support stem cell research; they propose specific criteria for informed consent for the use of the cells; and they delineate areas of research involving stem cells that are ineligible for NIH funding, including studies in which the cells are used to create or contribute to a human embryo, are combined with an animal embryo, are used for reproductive cloning of a human, are derived using somatic cell nuclear transfer into a human or animal egg, or are derived from human embryos created for research purposes.


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