Talk:Stem cell/Presidential and Congressional Background to Stem Cell Research

(Taken from the Congressional Research Service, obtained from the [Almanac of Policy Issues http://www.policyalmanac.org/health/archive/crs_stem_cell.shtml])

“In December 1994, President Clinton, through an executive directive, prohibited federal funding on research to support the creation of human embryos for research purposes and directed NIH not to allocate resources for such research. The order banning funding for such research was followed by a legislative ban in 1996 enacted in NIH's funding measure [the Dickey Amendment].

"…In light of the presidential and legislative bans, NIH requested a legal opinion from the General Counsel of HHS on whether federal funds could be used to support research on human stem cells derived from embryos or fetal tissue. HHS' General Counsel, Harriet Rabb, concluded that then-current law prohibiting the use of HHS appropriated funds for human embryo research would not apply to research using stem cells "because such cells are not a human embryo within the statutory definition." .. Rabb determined that the statutory ban on human embryo research defines embryo as an "organism" that when implanted in the uterus is capable of becoming a human being. The opinion stated that pluripotent stem cells are not and cannot develop into an organism, as defined in the statute. HHS concluded that NIH could fund research that uses stem cells derived from the embryo by private funds. But, because of the language in the rider, NIH could not fund research that, with federal funds, derived the stem cells from embryos.

"…In response to those opposed to the HHS opinion, and the subsequently published NIH guidelines, Secretary Shalala stated in a letter that the definition of embryo used in the HHS legal opinion relied on the definition of embryo in the statute and that the ban applied only to research in which human embryos are discarded or destroyed but not to research preceding or following "on such projects." The letter stated: "Moreover ... there is nothing in the legislative history to suggest that the provision was intended to prohibit funding for research in which embryos -organisms -are not involved."

"…After the HHS legal opinion, and despite expressions of congressional opposition, NIH indicated that it would fund research on pluripotent stem cells derived from human embryos and fetal tissue once guidelines were issued and an oversight committee was established. Draft guidelines were published in the Federal Register in December 1999 and final guidelines were issued in August 2000. The guidelines provided that studies utilizing pluripotent stem cells derived from human embryos may be conducted using NIH funds only if the cells were derived, without federal funds, from human embryos that were created for the purposes of fertility treatment and were in excess of the clinical need of the individuals seeking such treatment. Based upon HHS's interpretation, funds could not be used to extract or derive the stem cells from the embryo, thereby destroying the embryo. NIH initiated the applications process but ultimately funding was not granted to the applications. The prior administration's process was then overtaken by events and the new policy was set.""