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Stem Cell Research: Ethical Issues, ESCRO Committees, and Beyond

Stem Cell Research: Ethical Issues, ESCRO Committees, and Beyond. Michael Kalichman Biomedical Ethics Seminar Series May 17, 2006. Status of research. Not forbidden in U.S. Forbidden to use federal funds:

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Stem Cell Research: Ethical Issues, ESCRO Committees, and Beyond

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  1. Stem Cell Research:Ethical Issues, ESCRO Committees, and Beyond Michael Kalichman Biomedical Ethics Seminar Series May 17, 2006

  2. Status of research • Not forbidden in U.S. • Forbidden to use federal funds: • any project in which a human embryo would be "destroyed, discarded, or knowingly subjected to risk of injury or death“ (Dickey. 1996) • Federal funds may be used for research on stem cell lines derived prior to August 9, 2001 (Bush) • With non-federal funds this research is still allowable

  3. Stem Cell Sources • Adult, “tissue-specific” stem cells • Bone marrow • Umbilical cord blood • Brain, heart • Human embryo • IVF • Viable • Non-viable • SCNT, Cloning

  4. Hwang Woo Suk • Veterinary Researcher,Seoul National University,South Korea • Stem cell research funded extensively by Korean government and international community • Collaboration with U.S. scientist:Gerald Schatten • June 2005, Science: Nuclear transfer into 11 human eggs

  5. Hwang Woo Suk What went wrong? • Standards of research • Falsification of data • Fabrication of data • And it was stem cell research…

  6. November 24, 2005 “Being too focused on scientific development, I may not have seen all the ethical issues related to my research.” Hwang Woo Suk

  7. March 8, 2006 "The fraudulent stem-cell research reported by South Korean scientists suggests that American institutions are incapable of policing themselves to prevent similar scandals in this country, the chairman of a Congressional subcommittee said on Tuesday." Jeffrey Brainard, Wednesday, March 8, 2006 “Members of Congress Spar Over South Korean Cloning Scandal and Oversight of Stem-Cell Research in U.S.” Chronicle for Higher Education

  8. What are we doing? • RCR Courses • IRB and IACUC Reviews • NAS Guidelines • CIRM Guidelines

  9. What is supposed to be reviewed? • Covered stem cell line means a culture-derived, human stem cell population that is capable of: 1) sustained propagation in culture; 2) differentiation along multiple cell lineages; and 3) self-renewing to produce daughter cells with equivalent developmental potential. This definition includes both embryonic and non-embryonic human stem cell lines regardless of the tissue of origin • CIRM Draft Guidelines: 2/10/06

  10. What is supposed to be reviewed? • Covered stem cell line means a culture-derived, human pluripotent stem cell population that is capable of: 1) sustained propagation in culture; and (2) self-renewal to produce daughter cells with equivalent developmental potential. This definition includes both embryonic and non-embryonic human stem cell lines regardless of the tissue of origin. Pluripotent means capable of differentiation into mesoderm, ectoderm, and endoderm." • CIRM Draft Guidelines: 5/9/06

  11. Why should we review this research? • We already have review committees • Is hESC research different? • What interests are we protecting with review of hESC research?

  12. Special Respect "Persons holding the latter view-that the embryo itself lacks interests or rights because of its extremely rudimentary development--do not, however, necessarily view embryos as identical to any other human tissue. Indeed, many such persons would say that embryos, though lacking rights or interests in themselves, deserve "special respect" because of the embryo's potential, if placed in a uterus, to become a fetus and eventually to be born. Even embryos that will not be placed in the uterus have some meaning in this regard for they operate as a symbol of human life or constitute an arena for expressing one's commitment to human life.“(Robertson, 1999)

  13. Why should scientists insist on ethical review of hESC research? • Respect for life: developing embryo should be given closer scrutiny than adult cells • Ethical defensibility: strengthened by an independent ethical review • Public accountability: • watched closely by the public • especially by those who are morally opposed • we need a proactive and serious role in addressing the ethical dimensions of our work

  14. Goal for Discussion • Framework for review • Will not focus on: • separation of funding sources • apportioning intellectual property rights

  15. Ethical Dimensions ofStem Cell Research • Should we use human embryos? • What questions should be studied? • How should research be conducted? • Who should benefit? • Who should bear the costs? • Who decides?

  16. Ethical factors in hESC research 1. Special Respect 2. Why the study will be conducted 3. What will be studied 4. How the study will be conducted 5. Scientific merit

  17. Special Respect Russell and Burch, 1959

  18. Ethical factors in hESC research 1. Special Respect 2. Why the study will be conducted 3. What will be studied 4. How the study will be conducted 5. Scientific merit

  19. Why the study will be conducted

  20. Ethical factors in hESC research 1. Special Respect 2. Why the study will be conducted 3. What will be studied 4. How the study will be conducted 5. Scientific merit

  21. What will be studied

  22. Ethical factors in hESC research 1. Special Respect 2. Why the study will be conducted 3. What will be studied 4. How the study will be conducted 5. Scientific merit

  23. How the study will be conducted

  24. How the study will be conducted

  25. Ethical factors in hESC research 1. Special Respect 2. Why the study will be conducted 3. What will be studied 4. How the study will be conducted 5. Scientific merit

  26. Scientific merit

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