Chapter 7.E.2 Stem Cell Research

Notes: Stem Cell Research

1. Resources on Stem Cell Research.

There have been a number of important articles and symposia on stem cell research. See, e.g., Law, Science, and Innovation: The Embryonic Stem Cell Controversy, 38 J. L. Med. & Ethics 175-351 (2010); Stem Cell Symposium, 9 Yale Journal of Health Policy, Law, and Ethics 483 – 622 (2009);

Updated citation: Russell Korobkin, Stem Cell Century: Law and Policy for a Breakthrough Technology (2007) (with Stephen R. Munzer).

3. The Creation of Embryos for Stem Cell Research.

For assessments of the Bush-era policy on stem cell research, see Jordan Saltzberg, The Current Embryonic Stem Cell Research Federal Funding Policy, 29 J. Legal Med. 505 (2008); Yaniv Heled, On Presidents, Agencies and the Stem Cells Between Them: A Legal Analysis of President Bush’s and the Federal Government’s Policy on the Funding of Research Involving Human Embryonic Stem Cells, 60 Admin. L. Rev. 65 (2008); O. Carter Snead, Public Bioethics and the Bush Presidency, 32 Harv. J.L. & Pub. Pol’y 867; Richard O. Hynes, US Policies on Human Embryonic Stem Cells, 9 Molecular Cell Biology 993 (2008); and Yi-Chen Su & Albert Wai-Kit Chan, Mary Doe’s Destiny: How the United States Has Banned Human Embryonic Stem Cell Research in the Absence of a Direct Prohibition, 14 Rich. J.L. & Tech. 12 (2008).

States have taken varying approaches to stem cell research, with some promoting research and other prohibiting it. For an overview of state laws on stem cell research, visit National Conference of State Legislatures, Stem Cell Research at http://www.ncsl.org/IssuesResearch/Health/EmbryonicandFetalResearchLaws/tabid/14413/Default.aspx (updated January 2008). See also, Zach W. Hall, Stem Cell Research in California: The Intersection of Science, Politics, Culture, and Law, 10 Minn. J.L. Sci. & Tech. 1 (2009); Elisha Baron, Proposal 2: Michigan Voters End 30-Year Ban on the Destruction of Human Embryos for Stem Cell Research, 37 J.L. Med. & Ethics 155 (2009).

New Note 3.5. Obama and Stem Cell Research.

President Obama issued an executive order permitting federal funding for research using stem cells from embryos where appropriate procedures and consents had been employed to develop the stem cells. Executive Order 13505 Removing Barriers to Responsible Scientific Research Involving Human Stem Cells, available at http://www.whitehouse.gov/the_press_office/Removing-Barriers-to-Responsible-Scientific-Research-Involving-Human-Stem-Cells/. See Sheryl Gay Stolberg, Obama Lifts Bush’s Strict Limits on Stem Cell Research, NY Times, http://www.nytimes.com/2009/03/10/us/politics/10stem.html ; Joel B. Finkelstein, Change in Federal Stem Cell Funding Policy Spurs Interest in Field, 101 J. Natl. Cancer Inst. 626 (2009).

A federal district judge issued a preliminary injunction against the Executive Order in August 2010. Sherley v. Sebelius, 2010 WL 3296974 (D.D.C.). The court rejected the Order’s distinction between the use of federal funds to destroy human embryos and the use of federal funds to support research using human embryos:

ESC [human embryonic stem cell] research is clearly research in which an embryo is destroyed. To conduct ESC research, ESCs must be derived from an embryo. The process of deriving ESCs from an embryo results in the destruction of the embryo. Thus, ESC research necessarily depends upon the destruction of a human embryo.

Id. at 7. See also Gardiner Harris, U.S. Judge Rules Against Obama’s Stem Cell Policy, NY Times, http://www.nytimes.com/2010/08/24/health/policy/24stem.html.

For articles on FDA approval of clinical trials therapies developed from embryonic stem cells, see, Andrew Pollack, FDA Approves a Stem Cell Trial, NY Times, http://www.nytimes.com/2009/01/23/business/23stem.html; Mary Ann Liebert, FDA Grants Clinical Trial Permission for Human Embryonic Stem Cells, 28 Biotech. L. Rep. 161 (2009). The trials were approved shortly after President Obama took office.

4. Alternatives to the Destruction of the Embryo.

Researchers are continuing to explore harvesting adult stem cells as an alternative to embryonic stem cells. For an overview of the issues see, Amy Zarzeczny, et al., iPS Cells: Mapping the Policy Issues, 139 Cell 1032 (2009).

New Note 6. International Approaches to the Regulation of Stem Cell Research.

Stem cell regulations vary around the world. See Timothy Caulfield et al., Commentary - International Stem Cell Environments: A World of Difference, Nature Reports Stem Cells (2009) at http://www.nature.com/stemcells/2009/0904/090416/full/stemcells.2009.61.html.

The International Society for Stem Cell Research (ISSCR) published Guidelines for the Conduct of Human Embryonic Stem Cell Research 2006, which was prepared by leading stem cell scientists, lawyers, and bioethicists. It can be found at http://www.isscr.org/guidelines/ISSCRhESCguidelines2006.pdf. These Guidelines seek to promote responsible, transparent and uniform practices worldwide. For a detailed review, see Bernard M. Dickens, International Society for Stem Cell Research (ISSCR) Guidelines for the Conduct of Human Embryonic Stem Cell Research (December 2006), 27 Med. & L. 179 (2008).

In 2008, the ISSCR published the Guidelines for the Clinical Translation of Stem Cells http://www.isscr.org/clinical_trans/pdfs/ISSCRGLClinicalTrans.pdf.