1. Little Cells, Big Issues: The Ethics of Stem Cell Research Jeffrey Kahn, PhD, MPH Director and Maas Family Endowed Chair in Bioethics Center for Bioethics University of Minnesota

2. Speaker Disclosure  The speaker has no relevant financial relationships to disclose.

3. Background   Stem cell research Why are we interested? – –“master cells” – –Promise for understanding and treating a wide range of diseases Where do they come from? – –Human embryos—left over or created (UW) – –Discarded fetal tissue—abortions (Hopkins) – –Adult stem cells (U of MN, others) Implicates human embryo research Implicates human cloning research No real oversight system or process – –US approach to regulation: funding brings rules

4. How we Got Here  1998-2000—Clinton Administration response to ES cell isolation Longstanding ban on embryo researchLongstanding ban on embryo research NIH funding decisionNIH funding decision  August 9, 2001--Pres. Bush announces new federal ES cell policy  State activity NJ, CA, MANJ, CA, MA  Congress vote in 2006 on loosening restrictions?vote in 2006 on loosening restrictions?

5. Sources and Policies  Existing cell lines (J. Thomson and others) Bush Administration; August 9, 2001Bush Administration; August 9, 2001  Discarded fetal tissue (abortions) Clinton Administration; 1993Clinton Administration; 1993  Spare embryos (IVF clinics) HERP, NBAC, HFEA (UK), CA, Harvard linesHERP, NBAC, HFEA (UK), CA, Harvard lines  Created human embryos US private sector (ACT, Norfolk IVF), HFEA, CAUS private sector (ACT, Norfolk IVF), HFEA, CA Clones--somatic cell nuclear transferClones--somatic cell nuclear transfer –US private sector (ACT, others?), S. Korea, California, NJ, HFEA (therapeutic only)  Created hybrid embryos US private sector (precursor to ACT)US private sector (precursor to ACT)

6. Policy and Ethics  Public vs. private funding Limit is on use of federal fundsLimit is on use of federal funds  Sense that we can limit government endorsement by limiting public funds  Executive branch vs. Congress Secy. Thompson: “No limitation on private investment for embryo research” (Aug. 10, 2001; PBS NewsHour)Secy. Thompson: “No limitation on private investment for embryo research” (Aug. 10, 2001; PBS NewsHour)  Is legality of embryo research morally meaningful?

7. Moral Status of Human Embryos  Continuum from mere tissue to respect as persons  Potential vs. actual persons  Left over (“spare”) vs. created (including cloned)—the importance of intention  New techniques PGD to remove a single cellPGD to remove a single cell What if cloned embryos couldn’t develop past very early stage?What if cloned embryos couldn’t develop past very early stage?

9. Stem Cells and the Policy Gap   Embryo research ban no federal dollars (byproduct of abortion debate in Reagan I) private funding OK, but no required oversight   Very limited third-party payment for reproductive medicine no assessment of appropriateness   Very little self-regulation of ART   Limited liability in ART since modest expectations   BUT, Federal funding will bring federal rules and raise the bar for all

10. What’s at Stake?  Respect for embryos (however understood) vs. value of research  Influence of disease-based advocacy  Role of politics, religion, and ethics in science  How do we move forward as a matter of public policy?...