elsi and stem cell · 16 25-11-03 stem cell elsi somatic cell nuclear transfer absolutely not...

ELSI and Stem Cells Research

To do or not to do or how to do it

Somsak Chunharas

25-11-03 STEM CELL ELSI2

Why ELSI and Advanced Bio-medical Research

Generic double-edged nature of scientific discoveries well documented in human historyKnowledge about the most basic unit of life unique to individual may be difficult to handlePrevailing 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


Society has become more skeptic about scientific progress and collective good that can be attainedIntellectual properties sharing is becoming a more complex issue – who are entitled to share the benefitsCommercialization of scientific progresses

Why ELSI and Advanced Bio-medical Research


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 tolost opportunities


Facing Our Fundamental Values Facing Our Fundamental Values towards Life and Livingtowards Life and Living

How do we view conception? When does “human life” begin?How much do we favour eugenics?Relationship between individuals in the society : domination and exploit or care and help


How do we live and deal with “risk”?Fundamentalism or Pragmatism : can our values about life and living shift and change to accommodate/embrace new technologies?

Facing Our Fundamental Values Facing Our Fundamental Values towards Life and Livingtowards Life and Living


ELSI Issues in (Embryonic) Stem Cell Research

What is life? What do we consider as human? What is the the status of an embryo?Who owns embryo?Commercialization of human parts/tissues –sperms and eggs (for production of embryo)Living spare parts – human right and dignitySomatic cell transfer of human cells


Difficult Questions that Need to be Addressed

Can we do research on embryo at the expenses of a potential human life?Is it ethical to trade a (potential) human life with a potential treatment?Is it ethical to fertilize embryo purposefully for stem cell harvesting?


Is it ethical to use already fertilized ovum (through IVF) for stem cells? Who has the right to those embryos? 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?Is it ethical to sell eggs and sperms?

Difficult Questions that Need to be Addressed


What have been done to address the issues?

Consulting religious groups – no single set of values towards the beginning of lifeConsulting the legal experts – different rulings re the use of (thawed) embryo and commercialization of eggs and sperms and other human tissuesconsulting the society – inadequately informed and too diverse value to reach consensus


Religious Views about the beginning of Life

Islam 120 days after fertilizationrelative benefits to be weighted

Buddhist depending on who you askedno concept of fertilization and embryo3 conditions for the beginning of human life

Christianitycatholic – absolutely non-negotiablescientists – 14 days after fertilization


NOT ONLYNOT ONLYNo single set of values and judgment No single set of values and judgment across religionsacross religions

BUTBUTNo single (unanimous) value and judgmentNo single (unanimous) value and judgmentwithin each religionwithin each religion

ALSOALSONo single (unanimous) values even among those No single (unanimous) values even among those belonging to the same religion in the same countrybelonging to the same religion in the same country


Rulings So Far

Research on embryonot allowed at allallowed only for those coming from fertilization not from somatic cell transferallowed for those below 14 days (regardless of sources) – England


Use of (thawed) Embryoacceptable upon consent from both parentsno clear ruling in case of death or divorcesno commercialization is allowed/acceptedunused embryo must be destroyedunused embryo must be kept indefinitely

Rulings So Far


Commercialisation and use of eggs and sperms to produce new embryo for ES

no sale of any human tissues are allowedno explicit ruling against sale of human tissues of any kindsocially unacceptable to sale tissues for health or even research purposes ( donation only)prohibiting doctors from obtaining eggs for purposes other than IVFno explicit ruling against IVF for ES

Rulings So Far


Somatic Cell Nuclear Transferabsolutely not allowedallowed for ES harvesting only (therapeutic cloning) but not for reproductive purposesruling prohibiting medical personnel to do SCNT no ruling

Rulings So Far


Intellectual Property SharingOwners of tissues are not entitled to IP benefits though cell lines were produced out of the tissues obtainedthere should be explicit statement about IP sharing in the consent form when obtaining tissues for research (whether yes or no)

Rulings So Far


Most countries belong to the group Most countries belong to the group

““No Explicit Ruling of Any KindNo Explicit Ruling of Any Kind””


Key Infrastructure Needed(I)

(Re)inventing key social institutionthe mediaS&T authoritative bodiesReligious institutionsEducational institutions

Inventing new institutionsNational ELSI bodies? vs civic ELSI Groups


New legislative framework law governing IVF or Reproductive health in generallaw dealing with scientific practiceslaws governing medical practitionerslaw on intellectual property – international and nationaladditional rules and regulation in ethical research conduct

Key Infrastructure Needed(II)


Sources of Stem Cellshuman fetal tissues from spontaneous abortionhuman embryos (from IVF) but before reaching stage of mesoderm formationumbilical cord blood and adult homatopoietic stem cells fully informed consents needed for all sourcesUse limited for specific studies

Examples of Guidelines on Selected Issues in Thailand



Use of (Thawed) EmbryoUse for research permissible under consent Consent for research use should be voluntary and donor will put no further claim of ownershipconsent for research obtained separately from the treatment process, with no incentives (discount)Consent should be for specific studiesuse for research only when no need for infertility treatmentEmbryo with no traceable parents cannot be used


Aborted Embryos Aborted Embryos cannot be used for any purposescannot be used for any purposesexcept from spontaneous abortionexcept from spontaneous abortion


Eggs and Sperms acquisition for researchvoluntary and fully informed with informed consent of eggs and sperms donationprimary purposes of donation should be for treatment of infertility no explicit prohibition to use sperms and eggs to directly produce ES for researchUse for ES research should be consented only for left-over embryos



SCNTpermissible for ES research but not for reproductive cloningSCNT across species not allowedThai Medical Council prohibited doctors from carrying out cloning(SCNT) for any purposes



Use of adult stem cell and umbilicord stem cell for research

acquisition should be on voluntary basis onlydonation only with no compensation of any kindfully informed consent needed for those donationno subsequent claim of ownership from the side of the donor



Rules and Regulations on ELSIwill be in place

before the final successes and failuresof all promising advanced research

They may affect the speed but not the outcome of scientific development

elsi and stem cell · 16 25-11-03 stem cell elsi somatic cell nuclear transfer absolutely not...

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