	Introduction

On March 9, 2009, President Barack Obama signed Executive Order 13505, "Removing Barriers to Responsible Scientific Research Involving Human Stem Cells." Draft NIH guidelines were released on April 23, 2009. Final guidelines were issued on July 6, 2009. Although federal funding of embryonic stem cell research was briefly enjoined by a preliminary injunction between August 23 and September 9, 2010, the United States Court of Appeals for the D.C. Circuit ultimately rejected that argument and allowed federal funding of human embryonic stem cell research to continue under the 2009 guidelines. Circuit's opinion stand. 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. In contrast, as of January 8, 2013, a total of 200 stem cell lines are listed in the new NIH stem cell registry. Legislation introduced but not passed in the 111 th and 112 th Congresses would have codified the Obama stem cell policy, preventing reversal by future Administrations. However, even if such legislation had been enacted, the use of federal funds for the derivation of new human embryonic stem cell lines would still not be permitted as long as the Dickey Amendment remains in effect. One group, at the University of Wisconsin, derived stem cells from five-day-old embryos produced via in vitro fertilization (IVF). They believe the destruction of embryos for the purpose of harvesting embryonic stem cells is morally and ethically unacceptable and argue that researchers should use other alternatives, such as induced pluripotent stem (iPS) cells or adult stem cells, both described below, instead of embryonic stem cells. The rider, often referred to as the Dickey Amendment, prohibited HHS from using appropriated funds for the creation of human embryos for research purposes or for research in which human embryos are destroyed. George W. Bush Administration Stem Cell Policy

On August 9, 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 where the life and death decision has already been made." On June 20, 2007, President Bush signed Executive Order 13435 directing the support of "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." However, many scientists continued to stress that research should focus on all types of stem cells, including those derived from human embryos. 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's prohibition against federal funding of "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 federal law]." 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. During the consent process, the donor(s) were informed of the following: (1) the embryos would be used to derive human embryonic stem cells for research; (2) what would happen to the embryos in the derivation of human embryonic stem cells for research; (3) the human embryonic stem cells derived from the embryos might be kept for many years; (4) the donation was made without any restriction or direction regarding the individual(s) who may receive medical benefits from the use of the human embryonic stem cells, such as who may be recipients of cell transplants; (5) the research is not intended to provide direct medical benefit to the donors; (6) the results of research using the human embryonic stem cells may have commercial potential, and the donor(s) would not receive financial or any other benefits from any such commercial development; (7) whether information that could identify the donor(s) would be available to researchers. In December 2009, the agency created a new NIH registry of human embryonic stem cell lines that are eligible for use in research supported by federal funds.
Since FY1996, the Dickey amendment in Labor-Health and Human Services (HHS) appropriations 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 support of "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. The Supreme Court has declined to review that decision, letting the D.C. Circuit's opinion stand. As of January 8, 2013, a total of 200 stem cell lines are listed in the NIH registry.
Legislation introduced but not passed in the 111th and 112th Congresses would have codified the Obama stem cell policy, preventing reversal by future Administrations. However, even if such legislation had been enacted, the use of federal funds for the derivation of new human embryonic stem cell lines would still not be permitted as long as the Dickey Amendment remains in effect.