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Wednesday, February 1, 2012

Stem Cell Research: Science, Federal Research Funding, and Regulatory Oversight

Judith A. Johnson
Specialist in Biomedical Policy

Edward C. Liu
Legislative Attorney

Since FY1996, the Dickey amendment in appropriation acts has prohibited the use of federal funds for the creation of human embryos for research purposes or for research in which human embryos are destroyed. At the time, the Dickey amendment halted the development of guidelines by the National Institutes of Health (NIH) on the broad field of human embryo research and has each year since 1996 prohibited federal funding for human embryo research and related topics, including in vitro fertilization (IVF) and human embryonic stem cells. These cells have the ability to develop into virtually any cell in the body, and may have the potential to treat injuries as well as illnesses, such as diabetes and Parkinson’s disease. Currently, most human embryonic stem cell lines used in research are derived from embryos produced via IVF. Because the process of removing these cells destroys the embryo, some individuals believe the derivation of stem cells from human embryos is ethically unacceptable.

In August 2001, President George W. Bush announced that for the first time, federal funds would be used to support research on human embryonic stem cells. However, the Bush decision limited funding to research on 21 stem cell lines that had been created prior to the date of the August 2001 policy announcement. Scientists expressed concern about the quality and longevity of these 21 stem cell lines, believing that research advancement requires access to new human embryonic stem cell lines. However, those concerned about the ethical implications of deriving stem cells from human embryos argue that researchers should use alternatives, such as induced pluripotent stem (iPS) cells or adult stem cells (from bone marrow or umbilical cord blood). In June 2007, President Bush signed an executive order directing the “conduct and support research on the isolation, derivation, production and testing of stem cells that are capable of producing all or almost all of the cell types of the developing body and may result in improved understanding of or treatments for diseases and other adverse health conditions, but are derived without creating a human embryo for research purposes or destroying, discarding, or subjecting to harm a human embryo or fetus.” Many scientists continued to stress that research should focus on all types of stem cells, including those derived from human embryos.

On March 9, 2009, President Barack Obama signed an executive order that reversed the nearly eight-year-old Bush Administration restriction on federal funding for human embryonic stem cell research and the June 2007 executive order. The Obama decision directed NIH to issue new guidelines for the conduct of embryonic stem cell research. Draft guidelines were released on April 23, 2009, and final guidelines were issued on July 6, 2009. In December 2009, NIH created a new registry of human embryonic stem cell lines that are eligible for use in research supported by federal funds under the 2009 guidelines. Shortly after the 2009 guidelines were issued, opponents of human embryonic stem cell research brought suit in federal court arguing that federal funding of such research was barred by the Dickey amendment. Specifically, the litigation turned on whether HHS could lawfully interpret the term “research” to include only activities performed once human embryonic stem cells had been isolated, or whether “research” must also include the antecedent embryonic stem cell derivation activities that generally resulted in the destruction of human embryos. Although federal funding of embryonic stem cell research was briefly enjoined, the United States Court of Appeals for the D.C. Circuit rejected that argument and allowed federal funding of human embryonic stem cell research to continue under the 2009 guidelines. As of January 10, 2012, a total of 142 stem cell lines are listed in the NIH registry.

In the 112th Congress, legislation has been introduced that would codify the Obama stem cell policy. The Stem Cell Research Advancement Act (H.R. 2376) would allow federal support of research that utilizes human embryonic stem cells regardless of the date on which the stem cells were derived from a human embryo, provided that the stem cell lines met certain ethical guidelines. Other legislation (S. 88, H.R. 2951) would encourage possible alternatives to human embryonic stem cell research.

Date of Report: January 17, 2012
Number of Pages: 28
Order Number: RL33540
Price: $29.95

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