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Wednesday, September 22, 2010

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 August 23, 2010, a federal district court issued a preliminary injunction in the case of Sherley v. Sebelius enjoining the Department of Health and Human Services (HHS) from “funding research involving human embryonic stem cells.” The plaintiffs in the case, two researchers of adult stem cells, argued that funding such research violated the Dickey Amendment. HHS appealed and the Court of Appeals for the D.C. Circuit issued a stay of the preliminary injunction pending its consideration of the merits of the government’s appeal. The Sherley opinion would have effectively precluded the award of federal funding for such research if it had not been stayed by the D.C. Circuit; research is permitted to continue while the stay is effective. 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 August 19, 2010, a total of 75 stem cell lines are listed in the new registry.

In the 111
th Congress, four bills have been introduced to codify the Obama stem cell policy. H.R. 873 (DeGette), the Stem Cell Research Enhancement Act of 2009, 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. Stem cell lines must meet ethical guidelines established by NIH. H.R. 872 (DeGette), the Stem Cell Research Improvement Act of 2009, is similar to H.R. 873 but would require updates of the guidelines every three years. S. 487 (Harkin) is the same as H.R. 873, except it has an additional section supporting research on alternative human pluripotent stem cells. H.R. 4808 (DeGette), the Stem Cell Research Advancement Act of 2009, is similar to H.R. 873 and, like H.R. 872, would require guidelines review every three years, but it also would ban funding for reproductive human cloning. Other stem cell bills introduced in the 111th Congress include H.R. 877, H.R. 1654, H.R. 2107, S. 99, and three bills that reauthorize the Stem Cell Therapeutic and Research Act of 2005.

Date of Report: September 9, 2010
Number of Pages: 29
Order Number: RL33540
Price: $29.95

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