1. Stem Cell Research John David Godchaux Catherine Koehler Lela Prashad Hao Wu

2. Introduction and Issue Framing What are stem cells? – Precursor cells that can give rise to multiple types of tissue Three sources of stem cells – Embryonic stem cells; totipotent/pluripotent – Embryonic germ cells; pluripotent – Adult stem cells; multipotent

3. Introduction and Issue Framing Ethical dispute over ES cells – Opponents Life begins at fertilization and any research that facilitates embryo destruction should not be done Adult stem cells are equally as promising as ES cells – Proponents Embryos have no potential for life without implantation in a woman’s uterus In Vitro fertilization provides more embryos than needed. Morally permissible to use them for potentially life-saving research

4. Short History of Stem Cell Research 1995 Congressional ban on embryo research November 1998, Dr. James Thompson isolates 1 st ES cells (private funding) NBAC report; HHS determination (1999-2000) The President’s decision (August 9, 2001)

5. Policy Recommendations

6. “Federal funding is required because it has been historically proven that such funding promotes investment, helps develop sound policy, and will foster public confidence in the conduct of research.”

7. Reasons for funding Promote investment Develop policy Insure public confidence

8. Research parameters Public funding of only basic research Private sector as collector Respect for beliefs

9. Promotion of equitable access Universal health care dilemma Developing new public policies on access

10. Ethical and Legal Concerns

11. Documentation of Stem Cell Origins The method of obtaining stem cells must be made clear to researchers and patients so that individual ethics are not violated.

12. Intellectual Property Issues Public funded research generates patents that enhance dissemination of stem cell technology – Problems with patenting life forms Genetics as “common heritage” vs. idea that genetically engineered “products” do not occur in nature – Accessibility vs. property Majority of ES cell research is privately funded creating potential for restrictive use patents

13. Development of unified ethics code Federal oversight of stem cell research is necessary but private sector advances in ethical review must not be ignored – Private sector stem cell research has advanced quickly and has a valuable role to play in determining reasonable guidelines and creating laws on stem cell research – Individual company ethics boards should form networks with other private boards in order to share and exchange ideas on ethical ES cell practices.

14. Oversight and Public Education

15. Oversight Certain levels of oversight are necessary due to the apprehension and uncertainty evoked by the research which has important ethical and social implications. This overseeing system should include several key features: – Pluralistic—multiple access – Democratic—public involvement – Flexible—accommodate cutting-edge research – Compatible—scientific freedom vs. public accountability – Supporting private-public partnerships

16. Private Sector Oversight To date all advances in Stem Cell research have come from the private sector. Private sector sponsorship of research establishes a degree of internal oversight concerning ethical and social consideration. (say, the Ethics Advisory Board by Geron Corporation in Sep 1998). In light of the limitations of efforts by the private sector to provide ethical review, continued exclusive private funding may force the research proceeding without adequate attention to public priorities and ethical issues.

17. Public Sector Oversight The use of federal funding to support the research will trigger proper oversight mechanisms and guidelines to evolve where they are needed. Oversight Mechanisms Now in Place: – The Food and Drug Administration (FDA) – National Bioethics Advisory Commission (NBAC) – Recombinant DNA Advisory (RAC) – Federal Common Rule – Public Health Service Act – Food, Drug, and Cosmetic Act Federal units should cooperate with interested stakeholders in the conduct of the research so that the public can be assured that proper safeguards are in place as this research evolves.

18. Public Education Public should be educated and informed about the ethical and policy issues raised by the research and its application. And the public discussion should be based on their understanding of the science associated with the research. Scientists should communicate their research in ways understandable to a diverse audience. Congressional hearings, public meetings and media can play a key role in supporting an open manner that allows all those interested to observe and participate in these processes.