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Ethics of Human Therapeutic Cloning Research in Japan Current Debate of Drafting the Ethical Guideli

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Title: Ethics of Human Therapeutic Cloning Research in Japan Current Debate of Drafting the Ethical Guideli


1
Ethics of Human Therapeutic Cloning Research in
Japan- Current Debate of Drafting the Ethical
Guidelines
  • Ryuichi IDA, Prof.
  • Kyoto University School of Government
  • Eighth Asian Bioethics Conference (ABC 2007)
  • 19 March, Century Park Hotel, Bangkok, Thailand

2
Itinerary of Discussion and Regulation
  • 1997 Birth of Dolly Announced
  • 1997 Establishment of National Bioethics
    Committee
  • 2000 Legislation of Reproductive Cloning Ban
  • 2001 Human ES Cell Research Guidelines
  • 2001 Guidelines on Specified Embryos
  • 2003 First ES Cell Lines Derived in Japan
  • 2004 Basic Idea on Treatment of Human Embryo
    Decision of authorization of therapeutic cloning
    research
  • 2005 Working group on human therapeutic cloning
  • 2006 Interim Report of the WG

3
Reason of Reproductive Cloning Ban
  • Human Reproductive Cloning
  • ?Act contrary to the human dignity
  • 1) Intrumentalization of Human Being
  • 2) Violation of Individuality
  • 3) Deviation from the concept of human birth
  • leading to social and family disorder
  • Additionally
  • Safety of cloned human being

4
May therapeutic cloning be permitted ?
  • 1) The Law bans reproductive cloning only, but
    not therapeutic cloning.
  • Therapeutic cloning should be regulated by
    the guidelines of the Min. of Education.
  • No clear permission nor any rule for
    therapeutic cloning in the Law.
  • 2) ES cell research is permitted for the purpose
    of new medical care. Regenerative Medicine
  • The goal is to use ES cell derived from
    patients somatic cell nuclear transfer cell.
  • Once ES cell research is permitted,
    therapeutic cloning may not be denied.

5
Basic question Status of embryo in research
  • Principle
  • Human embryo should not be created for the
    purpose of research.
  • Human embryo should not be destroyed.
  • Human embryo has only reproductive
    purpose.
  • Exception
  • If there is an overriding reason, human embryo
    may be used for research. (Creation of embryo
    for research remains prohibited.)
  • Which kind of embryo? Supernumerary
    embryo
  • What kind of research? For new
    medical care of patients of

  • difficult diseases.
  • Therefore, human ES cell research is permitted.

6
How about therapeutic cloning ?
  • Arguments for permission
  • 1) Need for clinical application, because of
    immunological reason.
  • 2) Not banned by the Law.
  • 3) Preparedness for clinical application, once ES
    cell research obtains successful results
  • Arguments against permission
  • 1) Start to instrumentalization of human being
  • 2) Efficiency of ES cell therapy not yet proven
    (remains theoretical)
  • 3) Insufficient information and clarification on
    the development of ES cell research and
    realizability of therapeutic cloning.

7
Decision by the Bioethics Experts Panel of CSTP
  • Permission of therapeutic cloning research
  • Moratory Conditions
  • 1) Establishment of Guidelines
  • 2) Protection of woman donor of unfertilized
    egg
  • 3) Effective control of ban on reproductive
    cloning
  • 4) Requirement of scientific evidence
  • (In case the research reveals
    unsuccessful
  • useless, it should stop immediately.)

8
Ethical Issues of Human Therapeutic Cloning
Human embryo should not be created nor
destroyed for the purpose of research Research
for new medical care of difficult diseases
Reproductive cloning
Therapeutic cloning research
conditions
Donation of oocyte
Informed Consent
Objectives of research
Ethical Review
ES cell derived from cloned embryo
9
Conditions Interim Report of the WG 2006.06.20
  • 1)Objective of research
  • New medical care for difficult
    diseases only
  • ES cell lines should be derived
  • 2) Donation of oocytes
  • Strict limitation (see the next
    slide)
  • 3) Detailed Informed Consent Procedure required
  • Coordinator liaison function
    doctor /donor candidate
  • 4) Donation of Somatic cell
  • No new intervention or small intervention
    of routine kind
  • Anonymity required
  • 5) Strict requirements of research institution
  • Experience required
  • animal cloning, human ES cell
    derivation, participation of
  • experienced researcher of cloned
    embryo of primates
  • Appropriate ethical review
  • 6) No permission of voluntary donation of oocytes

10
Possibible donation of oocytes
  • 1)Oocytes taken from removed ovary
  • 2)Unfertilized egg obtained for assisted
    reproduction, but not used
  • 3)Unfertilized egg stored frozen for
    preservation, but become disused
  • 4)Case of death of the woman whose ovary or
    unfertilized egg was stored frozen

11
Factors taken into account
  • 1) Dichotomy of opinions regarding status of
    embryo
  • statistics 70 of population think
    that
  • human life begins at
    fertilization
  • (little religious
    background)
  • 2) Anxiety of the public toward scientific
    development
  • Intrusion of science into Gods field ?
  • Insufficiency of accountability of
    scientists
  • 3) Impact of Dr. Hwangs case in Korea
  • Distrust to scientists
  • Self-restraint from scientists side

12
Conclusion
  • Well balanced but sometimes very cautious
    approach has so far been taken in bioethical
    discussion.
  • Scientists often find these regulations too
    restrictive and claim the importance of freedom
    of research and their respect of human dignity
    and human rights in good faith. They are afraid
    of getting behind in scientific competition.
  • The public seems not so interested in this
    particular field of research. It is difficult for
    the public to grasp the scientific and
    technological as well as ethical issues
    concerning therapeutic cloning.
  • Accountability of scientists is the most
    important.
  • The role of the media should be taken into
    account (not in this presentation)

13
Thank you for your attention!
  • Thank also to the organizers,
  • in particular,
  • to Professor Soraj Hongradarom.
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