STEM CELL RESEARCH BASICS
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The following synopsis of past and current federal policy is based on a Congressional Research Service Report for Congress, Stem Cell Research, updated on August 10, 2005. Click here for the complete report (PDF). Current federal policy is based on President Barack Obama's Executive Order of March 9, 2009.
Prior to the August 2001 Bush Administration decision to allow federal funds for research on early human stem cells, the Dickey Amendment, which essentially restricts research related to human embryos, has been attached to the Labor, Health and Human Services (HHS) and Education Appropriations Acts since FY1997 through FY2008. The National Institutes of Health’s appropriations are included in the Human Health and Services’ appropriations.
For FY2008, the provision is found in Section 509 of the Labor, HHS, and Education and Related Agencies Appropriations Act, 2008 (H.R. 3043, H. Rept 110-424).
The Dickey Amendment states:
After the University of Wisconsin announcement about the derivation of early human stem cells from in vitro fertilization derived blastocysts in November 1998, the National Institutes of Health requested a legal opinion from HHS on whether federal funds could be used to support research on early human stem cells derived from embryos. The January 15, 1999 response from HHS General Counsel Harriet Rabb found that the Dickey Amendment would not apply to research using early human stem cells, “because such cells are not a human embryo within the statutory definition.” Since the statute defines an embryo as an “organism that when implanted in the uterus is capable of becoming a human being,” HHS maintained that NIH could support research that uses stem cells derived through private funds, but could not support research that itself, with federal funds, derives stem cells from embryos because of the federal ban in the Dickey Amendment.
Following the HHS announcement, NIH began drafting guidelines and established an oversight committee. The final guidelines were published in August 2000. The guidelines stated that studies utilizing “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.” Under these guidelines, NIH would not fund research directly involving the derivation of human early stem cells from embryos, thus not violating the Dickey Amendment.
With a deadline of March 15, 2001, NIH began accepting grant applications for research projects utilizing early human stem cells, however, none of the applications were funded in 2001 due to a review of the Clinton Administration policy by the Bush Administration. Then on August 9, 2001, President Bush announced that for the first time federal funds would be made available to support research on human embryonic stem cells, but funding would be limited to “existing stem cell lines where the life and death decision has already been made.”
The August 2001 policy statement by the Bush Administration effectively replaced the NIH stem cell guidelines that were developed under the Clinton Administration but never fully implemented. Grant proposals involving early human stem cell research underwent the normal peer-review process without added review of an oversight committee as specified in the Clinton NIH stem cell guidelines.
In February 2002, NIH announced the approval of the first expenditures for research on early human stem cells. Under Bush Administration policy, there were 78 stem cell lines eligible for use in research sponsored by NIH funding, however, only 22 of those lines from seven sources were actually available. The others were either unavailable or unsuitable for research.
On March 9, 2009, President Obama signed an Executive Order removing the Bush Administration’s limitations on federal funding for stem cell research. The Executive Order also directs the Secretary of Health and Human Services, through the Director of the NIH, to “review existing NIH guidance and other widely recognized guidelines on human stem cell research, including provisions establishing appropriate safeguards, and issue new NIH guidance on such research that is consistent with this order.” The Executive Order directs that this review must occur within 120 days.
President Obama’s issuance of the Executive Order rescinds the time limitations set by President Bush for stem cell federal funding eligibility, though the provisions of the Dickey Amendment remain in place.
