Timeline of Legal and Political Events

As restrictions interfere with the very strong desire of scientists to create and develop new stem cell technologies, US federal courts might also seek to encourage and protect stem cell research. If research demonstrates that hESCs could be used as an effective therapy (e.g., to repair spinal cord injury), would federal policy change? The intense debates over the conception and birth in 1978 of the world’s first IVF-generated child, “test tube” baby Louise Brown, soon dissipated as more infertile couples successfully used IVF to produce healthy offspring.

Courts recently entered the debate to address assertions that federal funding of hESC research is in violation of the Dickey-Wicker Amendment.

Brief timeline of key legal and political events concerning stem cell research

  • 1974: Congress initiated a temporary moratorium on federally-funded clinical research that used human embryos and embryonic tissue, including research on IVF, until national guidelines could be established.
  • 1975: The U.S. Department of Health and Human Services (DHHS) mandated regulations for research on embryos and refused to fund infertility or therapeutic research using human embryos.
  • 1979: The Ethics Advisory Board, created under the Carter administration, recommended that the government should fund research on embryos in an effort to improve IVF.
  • 1981: Embryonic stem cells are first cultured in mice (Evans and Kaufman at Cambridge; Martin at UCSF).
  • January 1996: The Dickey-Wicker Amendment was passed barring "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." (104th Congress 1995-1996)
  • 1998: Human embryonic stem cells were cultured and sustained for several months, thus allowing the cells to undergo self-renewal and differentiation - two fundamental properties of stem cells (J Thomson at University of Wisconsin and JD Gearhart at Johns Hopkins University).
  • January 1999: During the Clinton Administration, the NIH announced that "current law permits federal funds to be used for research using human pluripotent stem cells." This decision was based on the legal opinion of Harriet Rabb, General Counsel to the Department of Health and Human Services (HHS), who argued that since embryonic stem cells are not embryos they are not covered by the federal ban established under the Dickey-Wicker Amendment.
  • August, 2001: In a nationally televised speech, President Bush announced that the NIH will only fund research on human embryonic stem cell lines derived before August 9, 2001. At the time, there were estimated to be 78 cell lines included in the NIH registry, but, of these, only 21 were available for research and of these very few were appropriate for human use as most of the cell lines use mouse feeder cells.
  • 2005-2007: Congress tried twice to overturn the ban on federal funding of research on human embryonic stem cell lines derived after 2001, but President Bush vetoed the bill both times.
  • March 2009: Within two months of his inauguration, President Obama lifted the moratorium on federal funding, issuing an executive order that the NIH "may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent permitted by law." The expectation is that the NIH will develop guidelines to govern the stem cell research within its institutes.
  • July 7, 2009: New NIH guidelines went into effect, establishing criteria for use of previously derived human embryonic stem cell lines and for lines to be derived thereafter (National Institutes of Health, 2005).
  • August 2009: A group of plaintiffs led by adult stem cell scientists James Sherley and Theresha Deisher filed a lawsuit against the NIH and the US Department of Health and Human Services, arguing that federal funding of the research is in violation of the Dickey-Wicker amendment.
  • October 2009: Chief Judge Royce Lamberth of the US District Court in Washington D.C. dismissed the case, claiming that the plaintiffs are not being affected under the NIH’s current guidelines. The plaintiffs appealed.
  • June 2010: The US Court of Appeals for the District of Columbia Circuit reversed the decision, ordering that the case be sent back to Judge Lamberth.
  • August 23, 2010: Judge Lamberth granted the plaintiffs’ initial request for a preliminary injunction blocking all federal funding of human embryonic stem cell research while the case was being adjudicated. Within a week, the NIH freezed funding for all embryonic stem cell research within its institutes.
  • September 9, 2010: The Washington D.C. Court of Appeals blocked Judge Lamberth’s injunction, allowing funding to continue in the interim.
  • Several interim steps here, most importantly the Court of Appeals overruling Judge Lamberth in April, 2011.
  • July 27, 2011: Judge Lamberth ruleed that the US government can continue to fund embryonic stem cell research and dismissed the 2009 lawsuit by researchers Sherley and Deisher that challenged President Obama’s expansion of funding. Lamberth’s latest decision came almost a year after the Court of Appeals removed his August 2010 preliminary injunction on such grants.

  • For a more comprehensive timeline see: Vogel and Couzin-Frankel 2011

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