Infertility Stem Cell 1


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Infertility Stem Cell 1

  1. 1. ELSI and Stem Cells Research To do or not to do or how to do it Somsak Chunharas
  2. 2. Why ELSI and Advanced Bio-medical Research <ul><li>Generic double-edged nature of scientific discoveries well documented in human history </li></ul><ul><li>Knowledge about the most basic unit of life unique to individual may be difficult to handle </li></ul><ul><li>Prevailing values towards life and society ( what is life/eugenic/survival of the fittest/inter-dependent/coexistence) will undoubtedly dictate how we view research and its results </li></ul>
  3. 3. <ul><li>Society has become more skeptic about scientific progress and collective good that can be attained </li></ul><ul><li>Intellectual properties sharing is becoming a more complex issue – who are entitled to share the benefits </li></ul><ul><li>Commercialization of scientific progresses </li></ul>Why ELSI and Advanced Bio-medical Research
  4. 4. From sciences point of view, neglect of ELSI will eventually deter scientific progress From society point of view, failure to handle ELSI properly will lead to lost opportunities
  5. 5. Facing Our Fundamental Values towards Life and Living <ul><li>How do we view conception? When does “human life” begin? </li></ul><ul><li>How much do we favour eugenics? </li></ul><ul><li>Relationship between individuals in the society : domination and exploit or care and help </li></ul>
  6. 6. <ul><li>How do we live and deal with “risk”? </li></ul><ul><li>Fundamentalism or Pragmatism : can our values about life and living shift and change to accommodate/embrace new technologies? </li></ul>Facing Our Fundamental Values towards Life and Living
  7. 7. ELSI Issues in (Embryonic) Stem Cell Research <ul><li>What is life? What do we consider as human? What is the the status of an embryo? </li></ul><ul><li>Who owns embryo? </li></ul><ul><li>Commercialization of human parts/tissues – sperms and eggs (for production of embryo) </li></ul><ul><li>Living spare parts – human right and dignity </li></ul><ul><li>Somatic cell transfer of human cells </li></ul>
  8. 8. Difficult Questions that Need to be Addressed <ul><li>Can we do research on embryo at the expenses of a potential human life? </li></ul><ul><li>Is it ethical to trade a (potential) human life with a potential treatment? </li></ul><ul><li>Is it ethical to fertilize embryo purposefully for stem cell harvesting? </li></ul>
  9. 9. <ul><li>Is it ethical to use already fertilized ovum (through IVF) for stem cells? Who has the right to those embryos? </li></ul><ul><li>Is it ethical to do somatic cell nuclear transfer to produce stem cell? Is it possible to prevent them from being used for cloning new human beings? </li></ul><ul><li>Is it ethical to sell eggs and sperms? </li></ul>Difficult Questions that Need to be Addressed
  10. 10. What have been done to address the issues? <ul><li>Consulting religious groups – no single set of values towards the beginning of life </li></ul><ul><li>Consulting the legal experts – different rulings re the use of (thawed) embryo and commercialization of eggs and sperms and other human tissues </li></ul><ul><li>consulting the society – inadequately informed and too diverse value to reach consensus </li></ul>
  11. 11. Religious Views about the beginning of Life <ul><li>Islam </li></ul><ul><ul><li>120 days after fertilization </li></ul></ul><ul><ul><li>relative benefits to be weighted </li></ul></ul><ul><li>Buddhist </li></ul><ul><ul><li>depending on who you asked </li></ul></ul><ul><ul><li>no concept of fertilization and embryo </li></ul></ul><ul><ul><li>3 conditions for the beginning of human life </li></ul></ul><ul><li>Christianity </li></ul><ul><ul><li>catholic – absolutely non-negotiable </li></ul></ul><ul><ul><li>scientists – 14 days after fertilization </li></ul></ul>
  12. 12. NOT ONLY No single set of values and judgment across religions BUT No single (unanimous) value and judgment within each religion ALSO No single (unanimous) values even among those belonging to the same religion in the same country
  13. 13. Rulings So Far <ul><li>Research on embryo </li></ul><ul><ul><li>not allowed at all </li></ul></ul><ul><ul><li>allowed only for those coming from fertilization not from somatic cell transfer </li></ul></ul><ul><ul><li>allowed for those below 14 days (regardless of sources) – England </li></ul></ul>
  14. 14. <ul><li>Use of (thawed) Embryo </li></ul><ul><ul><li>acceptable upon consent from both parents </li></ul></ul><ul><ul><li>no clear ruling in case of death or divorces </li></ul></ul><ul><ul><li>no commercialization is allowed/accepted </li></ul></ul><ul><ul><li>unused embryo must be destroyed </li></ul></ul><ul><ul><li>unused embryo must be kept indefinitely </li></ul></ul>Rulings So Far
  15. 15. <ul><li>Commercialisation and use of eggs and sperms to produce new embryo for ES </li></ul><ul><ul><li>no sale of any human tissues are allowed </li></ul></ul><ul><ul><li>no explicit ruling against sale of human tissues of any kind </li></ul></ul><ul><ul><li>socially unacceptable to sale tissues for health or even research purposes ( donation only) </li></ul></ul><ul><ul><li>prohibiting doctors from obtaining eggs for purposes other than IVF </li></ul></ul><ul><ul><li>no explicit ruling against IVF for ES </li></ul></ul>Rulings So Far
  16. 16. <ul><li>Somatic Cell Nuclear Transfer </li></ul><ul><ul><li>absolutely not allowed </li></ul></ul><ul><ul><li>allowed for ES harvesting only (therapeutic cloning) but not for reproductive purposes </li></ul></ul><ul><ul><li>ruling prohibiting medical personnel to do SCNT </li></ul></ul><ul><ul><li>no ruling </li></ul></ul>Rulings So Far
  17. 17. <ul><li>Intellectual Property Sharing </li></ul><ul><ul><li>Owners of tissues are not entitled to IP benefits though cell lines were produced out of the tissues obtained </li></ul></ul><ul><ul><li>there should be explicit statement about IP sharing in the consent form when obtaining tissues for research (whether yes or no) </li></ul></ul>Rulings So Far
  18. 18. Most countries belong to the group “ No Explicit Ruling of Any Kind”
  19. 20. Key Infrastructure Needed(I) <ul><li>(Re)inventing key social institution </li></ul><ul><ul><li>the media </li></ul></ul><ul><ul><li>S&T authoritative bodies </li></ul></ul><ul><ul><li>Religious institutions </li></ul></ul><ul><ul><li>Educational institutions </li></ul></ul><ul><li>Inventing new institutions </li></ul><ul><ul><li>National ELSI bodies? vs civic ELSI Groups </li></ul></ul>
  20. 21. <ul><li>New legislative framework </li></ul><ul><ul><li>law governing IVF or Reproductive health in general </li></ul></ul><ul><ul><li>law dealing with scientific practices </li></ul></ul><ul><ul><li>laws governing medical practitioners </li></ul></ul><ul><ul><li>law on intellectual property – international and national </li></ul></ul><ul><ul><li>additional rules and regulation in ethical research conduct </li></ul></ul>Key Infrastructure Needed(II)
  21. 22. <ul><li>Sources of Stem Cells </li></ul><ul><ul><li>human fetal tissues from spontaneous abortion </li></ul></ul><ul><ul><li>human embryos (from IVF) but before reaching stage of mesoderm formation </li></ul></ul><ul><ul><li>umbilical cord blood and adult homatopoietic stem cells </li></ul></ul><ul><ul><li>fully informed consents needed for all sources </li></ul></ul><ul><ul><li>Use limited for specific studies </li></ul></ul>Examples of Guidelines on Selected Issues in Thailand
  22. 23. Examples of Guidelines on Selected Issues in Thailand <ul><li>Use of (Thawed) Embryo </li></ul><ul><ul><li>Use for research permissible under consent </li></ul></ul><ul><ul><li>Consent for research use should be voluntary and donor will put no further claim of ownership </li></ul></ul><ul><ul><li>consent for research obtained separately from the treatment process, with no incentives (discount) </li></ul></ul><ul><ul><li>Consent should be for specific studies </li></ul></ul><ul><ul><li>use for research only when no need for infertility treatment </li></ul></ul><ul><ul><li>Embryo with no traceable parents cannot be used </li></ul></ul>
  23. 24. Aborted Embryos cannot be used for any purposes except from spontaneous abortion
  24. 25. <ul><li>Eggs and Sperms acquisition for research </li></ul><ul><ul><li>voluntary and fully informed with informed consent of eggs and sperms donation </li></ul></ul><ul><ul><li>primary purposes of donation should be for treatment of infertility </li></ul></ul><ul><ul><li>no explicit prohibition to use sperms and eggs to directly produce ES for research </li></ul></ul><ul><ul><li>Use for ES research should be consented only for left-over embryos </li></ul></ul>Examples of Guidelines on Selected Issues in Thailand
  25. 26. <ul><li>SCNT </li></ul><ul><ul><li>permissible for ES research but not for reproductive cloning </li></ul></ul><ul><ul><li>SCNT across species not allowed </li></ul></ul><ul><ul><li>Thai Medical Council prohibited doctors from carrying out cloning(SCNT) for any purposes </li></ul></ul>Examples of Guidelines on Selected Issues in Thailand
  26. 27. <ul><li>Use of adult stem cell and umbilicord stem cell for research </li></ul><ul><ul><li>acquisition should be on voluntary basis only </li></ul></ul><ul><ul><li>donation only with no compensation of any kind </li></ul></ul><ul><ul><li>fully informed consent needed for those donation </li></ul></ul><ul><ul><li>no subsequent claim of ownership from the side of the donor </li></ul></ul>Examples of Guidelines on Selected Issues in Thailand
  27. 28. Rules and Regulations on ELSI will be in place before the final successes and failures of all promising advanced research They may affect the speed but not the outcome of scientific development