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Stem Cell Research
John David Godchaux
Catherine Koehler
Lela Prashad
Hao Wu
Introduction and Issue Framing
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What are stem cells?
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Precursor cells that can give
rise to multiple types of tissue
Three sources of stem cells
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Embryonic stem cells;
totipotent/pluripotent
Embryonic germ cells;
pluripotent
Adult stem cells; multipotent
Introduction and Issue Framing
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Ethical dispute over ES cells
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Opponents
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Life begins at fertilization and any research that facilitates
embryo destruction should not be done
Adult stem cells are equally as promising as ES cells
Proponents
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Embryos have no potential for life without implantation in a
woman’s uterus
In Vitro fertilization provides more embryos than needed.
Morally permissible to use them for potentially life-saving
research
Short History of Stem Cell Research
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1995 Congressional ban on embryo research
November 1998, Dr. James Thompson isolates
1st ES cells (private funding)
NBAC report; HHS determination (1999-2000)
The President’s decision (August 9, 2001)
Policy Recommendations
Policy Recommendations
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“Federal funding is
required because it has
been historically proven
that such funding
promotes investment,
helps develop sound
policy, and will foster
public confidence in the
conduct of research.”
Reasons for funding
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Promote investment
Develop policy
Insure public confidence
Research parameters
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Public funding of only
basic research
Private sector as
collector
Respect for beliefs
Promotion of equitable access
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Universal health care
dilemma
Developing new public
policies on access
Ethical and Legal Concerns
Documentation of Stem Cell
Origins
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The method of obtaining stem cells must be made
clear to researchers and patients so that individual
ethics are not violated.
Intellectual Property Issues
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Public funded research generates patents that
enhance dissemination of stem cell technology
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Problems with patenting life forms
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Genetics as “common heritage” vs. idea that genetically
engineered “products” do not occur in nature
Accessibility vs. property
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Majority of ES cell research is privately funded creating
potential for restrictive use patents
Development of unified ethics code
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Federal oversight of stem cell research is necessary
but private sector advances in ethical review must not
be ignored
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Private sector stem cell research has advanced quickly and
has a valuable role to play in determining reasonable
guidelines and creating laws on stem cell research
Individual company ethics boards should form networks with
other private boards in order to share and exchange ideas on
ethical ES cell practices.
Oversight and Public Education
Oversight
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Certain levels of oversight are necessary due to the
apprehension and uncertainty evoked by the research
which has important ethical and social implications.
This overseeing system should include several key
features:
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Pluralistic—multiple access
Democratic—public involvement
Flexible—accommodate cutting-edge research
Compatible—scientific freedom vs. public accountability
Supporting private-public partnerships
Private Sector Oversight
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To date all advances in Stem Cell research have come from the
private sector.
Private sector sponsorship of research establishes a degree of
internal oversight concerning ethical and social consideration. (say,
the Ethics Advisory Board by Geron Corporation in Sep 1998).
In light of the limitations of efforts by the private sector to provide
ethical review, continued exclusive private funding may force the
research proceeding without adequate attention to public priorities
and ethical issues.
Public Sector Oversight
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The use of federal funding to support the research will trigger
proper oversight mechanisms and guidelines to evolve where they
are needed.
Oversight Mechanisms Now in Place:
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The Food and Drug Administration (FDA)
National Bioethics Advisory Commission (NBAC)
Recombinant DNA Advisory (RAC)
Federal Common Rule
Public Health Service Act
Food, Drug, and Cosmetic Act
Federal units should cooperate with interested stakeholders in the
conduct of the research so that the public can be assured that
proper safeguards are in place as this research evolves.
Public Education
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Public should be educated and informed about the ethical and
policy issues raised by the research and its application. And the
public discussion should be based on their understanding of the
science associated with the research.
Scientists should communicate their research in ways
understandable to a diverse audience. Congressional hearings,
public meetings and media can play a key role in supporting an
open manner that allows all those interested to observe and
participate in these processes.