Timeline federal policy on stem cell research 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).

The Dickey Amendment (1997 — present)

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 FY2005. The National Institutes of Health’s appropriations are included in the Human Health and Services’ appropriations.

For FY2006, the provision is found in Section 509 of the Labor, HHS, and Education and Related Agencies Appropriations Act, 2006 (H.R. 3010, H. Rept 109-143).

The Dickey Amendment states:

None of the funds made available in this Act may be used for —
1. The creation of a human embryo or embryos for research purposes; or
2. Research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.208(a)(2) and Section 498(b) of the Public Health Services Act (42 U.S.C. 289g(b)).
For the purposes of this section, the term ‘human embryo or embryos’ includes any organism, not protected as a human subject under 45 CFR 46 [the Human Subject Protection regulations] as of the date of enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes [sperm or egg] or human diploid cells [cells that have two sets of chromosomes, such as somatic cells].

Clinton Administration Stem Cell Policy

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.

Bush Administration Stem Cell Policy

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.” [See Remarks by the President on stem Cell Reseach.]

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 undergo 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. There are currently 78 stem cell lines eligible for use in research sponsored by NIH funding, however, only 22 of those lines from seven sources are currently available. The others are either unavailable or unsuitable for research.

NIH Table .

Federal Funding for Stem Cell Research

The NIH Budget Office reports figures from FY 1999 to FY 2006 on federal funding of all types of stem cell research. From FY 1999 to FY 2004, all stem cell research has been allocated more than $2.24 billion. Less than 3 percent of the stem cell research budget, which equals approximately $55 million, has been allocated to the newly approved research with early human stem cells from FY 2002 to FY 2004. The figures for FY 2005 and FY 2006 are estimates and the National Institutes of Health is not prepared to speculate on the amount of research dollars that will support early human stem cell research in FY 2005 and FY 2006 at this time.

chart of NIH funding of stem cell research

For the most current information on pending legislation in the U.S. Congress, please visit the National Institutes of Health website on federal stem cell research policy.

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