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

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What is supposed to be reviewed? Why should we review this research? Special Respect Why should scientists insist on ethical review of hESC research? – PowerPoint PPT presentation

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


1
Stem Cell ResearchEthical 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. scientistGerald
    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
Category Questions
Replacement Can the research goals be met without destroying a human embryo and with an alternative approach that raises less severe ethical challenges?
Refinement If the research goals are best met by using human embryos, is it possible to do so without destroying the embryo or it is possible to do so by means that will not impair possible future development of the embryo?
Reduction Can the research goals be met with the use of fewer human embryos?

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
Category Questions
Basic research Is the primary purpose of the study a better understanding of biology or disease mechanisms?
Prevention Is the primary purpose of the study to develop treatments or devices that will prevent the occurrence of illness or disease?
Cure Is the primary purpose of the study to develop treatments or devices that will cure existing illness or disease?
Treatment Is the primary purpose of the study to develop treatments or devices that will treat, but not necessarily cure, existing illness or disease?
Enhancement Is the primary purpose of the study to develop treatments or devices that are designed to enhance the human condition?
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
Category Questions
Species Will this project involve human tissue? non-human primates? Mixing of human and non-human species?
Oocytes Who will be the donors? Will the research require that human oocytes, zygotes, or blastocysts be destroyed, discarded, or damaged?
Zygotes Who will be the donors? Will the research require that human oocytes, zygotes, or blastocysts be destroyed, discarded, or damaged?
Blastocysts Who will be the donors? Will the research require that human oocytes, zygotes, or blastocysts be destroyed, discarded, or damaged?
Fetus Who will be the donors? How did the fetal tissue become available?
Child or Adult Who will be the donors? What tissues will be donated?
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
Category Questions
Pain and suffering Will the study cause or risk injury of an organism that has sufficient neural organization to experience physical pain? self-awareness? memory?
Informed and voluntary consent How will informed consent be obtained? What measures will be taken to ensure that the consent is voluntary, not coerced, and informed?
Surrogate consent If the proposed donor lacks the capacity to provide informed and voluntary consent, will consent be provided by a surrogate who will adequately consider the interests of the donor?
Alternative uses Are the cells or tissues generated for the purpose of the research project or were they spontaneously or intentionally generated for some other use?
24
How the study will be conducted
Category Questions
Characterization Will the study consist only of genetic, biochemical, or morphological characterizations of cells?
Differentiation Will the study consist of genetic or chemical manipulations to induce differentiation or commitment to more specific lineages?
De-Differentiation Will the study consist of genetic or chemical manipulations to induce cells to revert to a less differentiated state?
Somatic cell nuclear transfer Will nuclear material from diploid cells be inserted into oocytes?
Mixing of species Will genetic material, cells or tissues of a non-human species be inserted into a human organism? Will genetic material, cells or tissues of human origin be inserted into a non-human species?
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
Category Questions
Clear hypothesis or question Is the proposed study designed to address a clearly stated hypothesis or question?
Awareness of literature Is the design of the proposed study consistent with what has previously been published?
Duplication of previous work Does the proposed study duplicate work that has already been done? If so, then is a rationale provided to adequately justify the need for the duplication?
Qualifications of personnel Are the personnel who will perform the studies adequately trained in science and methodology? in the ethical, legal, and social implications of this line of research?
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