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Wednesday, May 18, 2011

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

Judith A. Johnson
Specialist in Biomedical Policy

Erin D. Williams
Specialist in Public Health and Bioethics

On April 29, 2011, the United States Court of Appeals for the D.C Circuit held that the Department of Health and Human Services (HHS) could continue to fund research involving human embryonic stem cells. The decision overturned a preliminary injunction issued in August 2010 by a federal district court in the case of Sherley v. Sebelius that had enjoined HHS from funding such research. The plaintiffs in the case, two researchers of adult stem cells, argued that funding the research violated the Dickey Amendment. In September 2010, the Court of Appeals for the D.C. Circuit issued a stay of the preliminary injunction pending its consideration of the merits of an appeal filed by HHS. The Sherley district court opinion would have effectively precluded the award of federal funding for such research if it had not been stayed, and ultimately vacated, by the D.C. Circuit. The April 2011 decision allows funding to continue even though the underlying case may continue to be litigated.

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, but funding would be limited to “existing stem cell lines.” NIH established a registry of such cell lines eligible for use in federally funded research; 21 lines were available due to technical reasons and other limitations. Over time, scientists became increasingly concerned about the quality and longevity of these 21 stem cell lines. These scientists believe that research advancement requires access to new human embryonic stem cell lines. 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). However, many scientists believe research should focus on all types of stem cells.

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. 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. As of May 2, 2011, a total of 91 stem cell lines are listed in the new registry.

In the 112
th Congress, legislation (S. 88, Vitter) has been introduced that would encourage possible alternatives to human embryonic stem cell research. In the 111th Congress, several bills would have codified the Obama stem cell policy. These bills would have allowed 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 bills introduced in the 111th Congress aimed to reauthorize the Stem Cell Therapeutic and Research Act of 2005; S. 3751 became law on October 8, 2010 (P.L. 111-264).

Date of Report: May 3, 2011
Number of Pages: 30
Order Number: RL33540
Price: $29.95

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