April 5, 2007
Advanced Legal Research
THE LEGALITY OF STEM CELL RESEARCH:
Stem cells are the building blocks of the human body. Scientists have the capability to use embryonic stem cell lines to develop more than 200 cell types of the human body, meaning stem cells are a potential source for regenerative medicine and tissue replacement after injury and disease.1 For a better understanding of the scientific process behind stem cell research, the following resources are helpful:
- Wikipedia, The Free Encyclopedia > Stem Cell
This encyclopedia is a great place to begin to get background information about what stems cells are and about the science of stem cell research.
- MSNBC > Home > Health > Stem Cell Research
This site is good for its pictorial representation of the four steps of harvesting stem cells and a brief explanation of each step.
Stem cell research is controversial because it involves destruction of human embryos and/or therapeutic cloning. Because stem cell research implicates issues akin to abortion and cloning, a host of ethical questions arise regarding the level of legal protection it should be afforded. No approved medical treatments have been derived from stem cell research primarily because of federal law.2
President Bush’s policy on stem cell research currently restricts federal funding to existing stem cell lines, which have been ethically derived from surplus embryos. Precursory stem cell law began in 1973 following the Supreme Court decision in Roe v. Wade, when what is today the Department of Health and Human Services initiated a moratorium on any funding of research using human fetuses. Inaction by the government agency led to an institutional silence before President Regan took a formal stance against fetal tissue implantation in 1988.3
The National Institute of Health (NIH), which is the largest source of scientific research funds in the nation, then began a voluntary moratorium. In 1993, President Clinton lifted the moratorium on federally funded fetal tissue research and established the National Bioethics Advisory Commission (NBAC). However, before any funding decisions could be finalized, Congress passed the Dickey Amendment which prohibited the Department of Health and Human Services from using appropriated funds for the creation of human embryos for research purposes or for research in which human embryos are destroyed.4
In 1999 the NIH published a set of embryo research guidelines in the Federal Register. Yet, in 2001 before the NIH could make any funding decisions pursuant to their new guidelines, President Bush put NIH on hold and announced his decision to restrict federal funding to existing cell lines. He also dismantled the NBAC and established the President’s Council on Bioethics.5 At this point, the legality of stem cell research is hardly at rest, as new bills and regulations are continually being proposed.
For better background information on the legality of stem cell research, the following resources are helpful:
- National Resource Center for Bioethics Literature – Scope Note Series > Fetal Tissue Research
This source “is not designed as a comprehensive review, but rather offers immediate references to facts, opinions, and legal precedents for scholars, journalists, medical and legal practitioners, students, and interested laypersons.”
- International Society for Stem Cell Research > Glossary
This page is excellent for the glossary of stem cell related terms, which can be used in generating research terms.
The following are terms and phrases to consider in beginning stem cell research:
|-Adult Stem Cells
||-Embryonic Stem Cells
||-Stem Cell Controversy
||-Fetal Tissue Research
||-Stem Cell Research
||-In Vitro Fertilization
||-Stem Cell Transplants
||-Pluripotent Stem Cells
Stem cell research implicates various provisions of the Constitution depending upon the more narrow issue involved such as funding or ethical considerations. The equal protection and due process clauses of the 14th Amendment are especially relevant.
- U.S. Const. art. III, § 2
Under the Annotations, specifically note Due Process of Law > Substantive Due Process and Noneconomic Liberty > Abortion, for the Supreme Court’s interpretation that the word “person” in the 14th Amendment does not include the unborn.
Federal law for stem cell research includes much legislative history as well as ongoing proposed bills for future policy. The sources below contain highlights of important law as well as places for more in-depth research. Aside from these sources, it is easiest to search for federal stem cell law directly on the government websites listed toward the end of this pathfinder.
- Office of Legislative Policy and Analysis – 108th Congress > Pending Legislation
This government website links the NIH and Congress. It lists legislation relevant to NIH for the 108th – 110th Congress. It also links to relevant public laws and pending legislation from the 107th – 109th Congress and relevant NIH participation in Congressional Hearings from 108th Congress – 110th Congress. This is a great place to find summaries of proposed stem cell law.
- National Human Genome Research Institute > Policy and Ethics > Search the Database
This is a searchable database which includes federal law, federal administrative and executive material, and federal legislative materials. It can be searched by the topic “Stem Cell Research” and links to documents through Thomas and GPO access. Many documents are available in PDF.
Highlights of Current and Past Legislation:
- Public Law 109-129: The Stem Cell Therapeutic and Research Act of 2005
The Act requires the Secretary of Health and Human Services to contract with qualified cord blood stem cell banks to assist in the collection and maintenance of 150,000 new units of high-quality cord blood to be made available for transplantation through the C.W. Bill Young Cell Transplantation Program.
- U.S. Food and Drug Administration – Public Heath Service Act (references to Title 42 of the United States Code)
Through the Public Health Service Act, the FDA is responsible for regulating drugs and products developed through stem cell and other biological research. Much proposed legislation is aimed at amending the Act to broaden FDA guidelines, which can be found at: http://www.fda.gov/cber/guidelines.htm.
- Public Law 104-99, §128: The Dickey Amendment
Signed by President Clinton in 1995, this amendment prohibited federally appropriated funds to be used for research where human embryos would be either created or destroyed. This rider has been attached to every subsequent Labor/Health and Human Services appropriations bill since 1996.
Highlights of Proposed Legislation:
Federal administrative law for stem cell research has varied, corresponding mainly to the various presidencies over the past 30 years. Because most of the federal agencies have government websites, it is easiest to directly search there, using the links listed toward the end of this pathfinder. However, the National Human Genome Research Institute database, listed under the Federal Law section, is also an excellent source for finding administrative law. Below are selected sources that highlight federal administrative policies on stem cell research.
Highlights of Recent Law:
- 72 FR 2892: Department of Health and Human Services – Notice of the Establishment of Advisory Council on Blood Stem Cell Transplantation and Solicitation of Nominations for Membership
Released in January 2007, this notice announces the establishment of the Advisory Council on Blood Stem Cell Transplantation. The council will advise the Secretary of Health and Human Services on proposed C.W. Bill Young Transplantation Program policies and other such matters as the Secretary determines.
- Executive Order 13237: Creation of the President’s Council on Bioethics
Issued in November 2001 by President Bush, the order established the council to advise the President on ethical issues related to advances in biomedical science and technology. The council replaced the National Bioethics Advisory Council.
- President Bush Addresses Federal Funding for Stem Cell Research
Addressing the nation in August 2001, President Bush concludes that federal funds will only be permitted for research on the more than 60 genetically diverse stem cell lines that currently exist. He state that this policy “allows us to explore the promise and potential of stem cell research without crossing a fundamental moral line by providing taxpayers funding that would sanction or encourage further destruction of human embryos that have at least the potential for life.”
- 66 FR 57107: Department of Health and Human Services – Notice of Withdrawal of National Institute of Health Guidelines for Research Using Human Pluripotent Stem Cells
Published in November 2001, this notice withdrew the NIH research guidelines as they were unnecessary since President Bush had announced his criteria to allow federal funding for research using existing embryonic stem cell lines.
Highlights of Past Law:
- President’s Council on Bioethics Report – Human Cloning and Human Dignity: An Ethical Inquiry
Released in July 2002, the report called for a complete ban on reproductive cloning.
- 65 FR 51976: Department of Health and Human Services – National Institute of Health Guidelines for Research Using Human Pluripotent Stem Cells
Released in August 2000, the guidelines were to ensure that federally funded stem cell research was conducted in an ethical and legal manner. The guidelines stated that “utilizing pluripotent stem cells derived from human embryos may be conducted using NIH funds only if the cells were derived (without federal funds) from human embryos that were created for the purpose of fertility treatment and were in excess of the clinical need of the individuals seeking such treatment.”
- NBAC Report – Ethical Issues in Human Stem Cell Research
Released in September 1999, the report recommended that federal funding should be available for stem cell research, but limited to research involving stem cells obtained from cadaveric foetal tissue on or from stem cells obtained from surplus embryos remaining after infertility treatment.
- Memorandum for the Heads of Executive Departments and Agencies – Prohibition on Federal Funding for Cloning of Human Beings
Released by President Clinton in March 1997, the memorandum declared that no federal funds should be allocated for cloning human beings.
- Executive Order 12975: Protection of Human Research Subjects and Creation of National Bioethics Advisory Commission
Issued in October of 1995, by President Clinton, the order established the NBAC to advise the President on bioethical issues arising from research on human biology and behavior.
State laws on stem cell research vary widely. States including CA, CT, MD, MA, and NJ have statutes that encourage embryonic stem cell research, while others such as SD strictly forbid stem cell research from any source. Below are resources to find state statutes and policies on stem cell research.
- National Conference of State Legislature > State Embryonic and Fetal Research Laws
This is an excellent source for individual state statutes on stem cell research. The site begins with an overview of how state law can differ from federal law and then highlights important state activity about stem cell funding. The best part of the site is the chart of state stem cell research laws, which provides links to the relevant state statutes.
- National Conference of State Legislature > Genetics Legislation Database
This is a searchable database which contains information on genetic bills and related research issues including stem cell research. The database includes bills considered in state legislatures from 2004 to the present and is updated monthly.
- National Human Genome Research Institute > Policy and Ethics > Search the Database
This is a searchable database which includes both federal and state laws, regulations, and policies related to genetics, including stem cell research. It is especially useful because you can search by using the US State Map, and retrieve a chart of laws, organized by year, and distinguishable by topics (which include stem cell research).
The SC has examined issues on the periphery, but has not spoken on the particular issue of interpreting congressional intent regarding stem cell research.
- The White House – President Discusses Stem Cell Research Policy
This is a transcript of the President speaking about his stem cell research policy on July 19, 2006. The address is also available in video or audio through the site. There are links to “Fact Sheet: President Bush’s Stem Cell Research Policy” and “President Vetoes HR 810, the Stem Cell Research Enhancement Act of 2005.”
- The President’s Council on Bioethics > Stem Cells
Established in 2001 by Executive order 13237, the council advises the President on bioethical issues that emerge as a consequence of advances in biomedical science and technology. The site has links to Reports, Transcripts, and background Material from the council on stem cell research.
- U.S. Department of Health and Human Services – The National Institute of Health – Resources for Stem Cell Research
Devoted entirely to federal stem cell research, this cite is invaluable but particularly useful for its page on “Federal Policy,” its “FAQs,” and its “Links to related resources.”
- NIH – Bioethics Resources on the Web > Stem Cell Research
This site provides links to credible stem cell research sources, including the NIH, Stem Cells: The International Journal of Cell Differentiation and Proliferation, and MedlinePlus Health Information Site on Stem Cells and Stem Cell Transplantation. Particularly helpful is the link to the National Bioethics Advisory Commission (NBAC), which has archived reports from the Commission whose charter expired in October 2001.
- Stem Cell Research Foundation
Stem Cell Research Foundation (SCRF) is a federal organization that awards grants to support innovative research in the area of stem cell therapy. Since 2001, it has awarded more than $2.5 million and currently supports 7 research grants. The site has useful links, principally about funding, under its What’s New section.
- International Society for Stem Cell Research
The International Society for Stem Cell Research (ISSCR) is an independent, nonprofit organization formed in 2002 to further the exchange of information on stem cell research. Particularly useful is the site’s News Archive.
- Genome News Network > Stem Cells – Policies and Players
Genome News Network (GNN) is a trusted online magazine that covers important developments in genomics research around the world. Under Stem Cells, the site has links to Legislation, listed by country, and Stem Cell News, archiving its articles.
- Do No Harm – The Coalition of Americans for Research Ethics
Founded by doctors, this site advocates to advance the development of medical treatments and therapies that do not require the destruction of human life, including the human embryo. It is great because it has very current links to stem cell research in the news from credible newspapers, as well as commentary from doctors and other professionals.
- Stem Cell Policy: World Stem Cell Map
This site is really neat for the world map that reflects national policy on stem cell research and whether or not public funds may be used. It also lists many citing references. However, made by an employee of the University of Minnesota, this site is unofficial and not affiliated with the university.
Selective Law Reviews:
- Lauren Thuy Nguyen, The Fate of Stem Cell Research and a Proposal for Future Legislative Regulation, 46 Santa Clara L. Rev. 419 (2006)
This article is great because it explores the interplay between federal law restricting funding of stem cell research and state law attempting to circumvent such limitations. It advocates for a national policy that avoids the problems associated with a patchwork of federal and state regulations.
- Ryan Fujikawa, Federal Funding of Human Embryonic Stem Cell Research: An Institutional Examination, 78 S. Cal. L. Rev. 1075 (2005)
This article is particularly useful for its historical look at stem cell research law beginning with the Reagan Administration in 1988 through the current Bush Administration. It then advocates for a change in the current institutional arrangement by proposing to revitalize the NIH.
- Valerie J. Janosky, Stem Cells: Potential Cures or Abortion Lures?, 6 DePaul J. Health Care L. 111 (2002)
This article walks through some of the specific diseases that stem cell research is focused on curing. It then provides a good summary of legislative history and an overview of stem cell research law under the current Presidential administration. It advocates for the continued support of health law legislation, but presents both sides of the ethical debate surrounding stem cell research.
- Georgetown Law Library, In-Depth Research: Bioethics
Credible because it’s from a well-known school’s law library, this pathfinder is broader than stem cell research, but very thorough with many relevant links.
- Starting point for anyone who wants to research embryonic stem cell research
Although not very thorough, there are useful links for researching whether embryonic stem cell research should or should not receive government funding.
1 Stem Cell. Wikipedia, The Free Encyclopedia. Retrieved April 5, 2007 at http://en.wikipedia.org/wiki/Stem_cell.
3 Ryan Fujikawa, Federal Funding of Human Embryonic Stem Cell Research: An Institutional Examination, 78 S. Cal. L. Rev. 1075, 1080 (2005).
4 Id. at 1081-1083.
5 President Bush Addresses Federal Funding for Stem Cell Research. Retrieved April 5, 2007 at http://www.whitehouse.gov/news/releases/2001/08/20010809-1.html.