Legislators Toolkit: Federal Public Policy

Federal Policy To Date

On August 23, 2010, Judge Royce C. Lamberth issued a preliminary injunction in Sherley et al. v. Sebelius, a case that challenges the current NIH guidelines surrounding stem cell research. This effectively forced the NIH to cease funding stem cell research projects, but the agency has since rescinded that policy based on a higher court's temporary stay of the preliminary injunction. The legal proceedings are ongoing, and the NIH stem cell research website is currently tracking new developments. The Coalition for Advancing Medical Research (CAMR) is also posting legal documents as they become available. The information that follows is up-to-date and accurate.

Current federal policy surrounding embryonic stem cell research dates back to decisions made across three presidential administrations. The NIH guidelines now in place state that, in order for federal funding to be spent on stem cell research, the embryos from which the stem cells are derived must have been created through in vitro fertilization for reproductive purposes, must have been in excess of what was needed, and must have been donated by individuals who gave written consent.

Federal funding for the actual derivation of stem cells from human embryos is prohibited. Also prohibited is funding for research on stem cells derived from somatic cell nuclear transfer, parthenogenesis, and/or IVF embryos created for research purposes; funding for research in which human-induced pluripotent stem cells are introduced into non-human primate blastocysts; or funding for animal breeding research in which human embryonic stem cells or human-induced pluripotent stem cells may contribute to the germ line.

For stem cell lines that existed before the most current guidelines were issued, the NIH instructs institutions to submit information to the Working Group of the Advisory Committee to the Director (ACD), which ultimately makes recommendations regarding research eligibility.

Background

Starting during the Clinton Administration in 1996, and continuing every year since, Congress has included an amendment in the Departments of Labor, Health and Human Services, Education, and Related Agencies appropriations bill that prohibits federal funding for human embryonic stem cell research.  Named the Dickey-Wicker Amendment, it contains language that has not changed substantially since it was originally established. For FY 2010, the provision is found in Section 509 of the "Consolidated Appropriations Act, 2010" (H.R. 3288, P.L. 111-117).

The Dickey-Wicker Amendment states that:

• 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 46.204(b) 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].

In 1998, with the Dickey-Wicker Amendment in place, privately funded researchers at the University of Wisconsin-Madison and Johns Hopkins University School of Medicine isolated and cultured pluripotent stem cells. This breakthrough spurred the Clinton Administration to revisit the issue. In a January 1999 letter to the Director of the NIH, HHS General Counsel Harriet Rabb concluded that "federally funded research that utilizes human pluripotent stem cells would not be prohibited by the HHS appropriations law [the Dickey-Wicker Amendment] prohibiting human embryo research, because stem cells are not human embryos." Rabb came to this decision by noting that the Dickey-Wicker Amendment defined an embryo as an "organism," and determining that pluripotent stem cells were not "organisms" according the term's scientific definition. What the Dickey-Wicker Amendment prohibited was federal funding for the actual derivation of stem cells from embryos. Thus, the NIH could, in fact, support scientific research on pluripotent stem cells, but those stem cells must have been derived with private funding.

Shortly thereafter, the NIH issued guidelines based on this interpretation and initiated the process for funding applications. However, as the Bush Administration took office in 2001, the applications process was stopped pending review of the guidelines. Later in 2001, President Bush issued a new policy surrounding embryonic stem cell research funding. According to this policy, federal funds would "only be used for research on existing stem cell lines that were derived: 1) with the informed consent of the donors; 2) from excess embryos created solely for reproductive purposes; and 3) without any financial inducements to the donors." In addition, the President stated that "no federal funds will be used for: 1) the derivation or use of stem cell lines derived from newly destroyed embryos; 2) the creation of any human embryos for research purposes; or 3) the cloning of human embryos for any purpose." This policy effectively limited federal funding for stem cell research to stem cell lines that were in existence at the time of the decision. Seventy-eight lines were available, but only twenty-two were viable for research purposes.

Current Policy

On March 9, 2009, newly inaugurated President Obama signed an Executive Order removing the Bush Administration's limitations on federal funding for stem cell research. The Executive Order also directed the Secretary of Health and Human Services, through the Director of the NIH, to "review existing NIH guidance and other widely recognized guidelines on human stem cell research, including provisions establishing appropriate safeguards, and issue new NIH guidance on such research that is consistent with this order." President Obama's Executive Order rescinded the time limitations set by President Bush for stem cell federal funding eligibility, though the provisions of the Dickey-Wicker Amendment still remained in place.

The NIH, consistent with President Obama's Executive Order, issued its final guidelines for embryonic stem cell research on July 6, 2009. As noted above, the guidelines state that, in order for federal funding to be spent on stem cell research, the embryos from which the stem cells are derived must have been created through in vitro fertilization for reproductive purposes, must have been in excess of what was needed, and must have been donated by individuals who gave written consent.

Federal funding for the actual derivation of stem cells from human embryos is prohibited. Also prohibited is funding for research on stem cells derived from somatic cell nuclear transfer, parthenogenesis, and/or IVF embryos created for research purposes; funding for research in which human-induced pluripotent stem cells are introduced into non-human primate blastocysts; or funding for animal breeding research in which human embryonic stem cells or human-induced pluripotent stem cells may contribute to the germ line.

For stem cell lines that existed before the most current guidelines were issued, the NIH instructs institutions to submit information to the Working Group of the Advisory Committee to the Director (ACD), which ultimately makes recommendations regarding research eligibility.