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Ethics and Policy
Why Ethics?
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Controversy: We respect people’s views about
embryos and stem cells while conducting
good research.
Respect: We avoid infringing on the rights of
research donors.
Health: We maximize benefits to people and
minimize risks.
Integrity: We fulfill our duties to the scientific
community as a whole.
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Origins of Research Ethics
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NUREMBERG
• Participation in research must be VOLUNTARY.
• Research Participants must be INFORMED
about the consequences of participating.
HELSINKI
• Certain populations are more VULNERABLE to
coercion or harm and should be protected.
• All research must have independent
OVERSIGHT to make sure the benefits are
greater than the risks.
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Applied Research Ethics
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How does this effect stem cell research?
• People who donate embryos, gametes or tissues to
stem cell research are research participants.
• This means they must give informed consent to
donate.
• No one should ever be pressured to donate their
tissues or misled about the advantages that may
come from donating tissues.
• If individuals are compensated for their tissues,
this must be carefully documented.
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Applied Research Ethics
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Informed consent requires that research participants substantially
understand:
– How their tissues will be used,
– That they will not benefit from the research,
– That they have no financial interest in the outcomes,
– How much they will be compensated,
– That they may withdraw their tissues from
the research at any time,
– That their participation will be private and
confidential.
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International Variation
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• Different countries have different laws and policies about stem
cell research.
• In some countries, embryonic stem cell research is illegal.
• Others have strict rules concerning research donations.
• The International Society for Stem
Cell Research (ISSCR) is a
professional society that issues
guidelines for best practices in stem cell
research.
• If all researchers follow the guidelines,
international collaboration is possible.
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US Regulations
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• The Common Rule
• 45 Code of Federal
Regulation 46 - Protection of
Human Subjects.
• National Institutes of Health
- Office of Human Subjects
Research.
• The Dickey-Wicker
Amendment
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Applying US Regulations
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• Different organization contribute to the development of
US policies.
• The National Academies of Science (NAS) issues
guidelines that are based on the dominant scientific
consensus.
– These provide guidance to individuals and institutions when
there are no clear laws.
• The National Institutes of Health (NIH) provides
most of the Federal funding for stem cell research.
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Applying US Regulations
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• The National Institutes of Health
(NIH) maintains a registry of all
embryonic stem cell lines that can be
worked with using Federal grant
funds.
• If you are working with Federal funds, or you want to
collaborate with someone who uses Federal funds, you
should check the registry before beginning.
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Legal Challenges
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• In 2010, a Federal judge issued a judgment that ANY
Federal funding for work with embryonic stem cell lines
may be a violation of the Dickey-Wicker amendment.
• The question will be decided in Federal court and may go
to the Supreme Court.
• Until the Court reaches a conclusion,
existing Federal funding for
embryonic stem cell research will most
likely continue.
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Funding Sources
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• Because Federal funding for
embryonic stem cell research
is so uncertain, other sources
of funding have been found:
– Some US States have begun
providing funding using State
funds.
– Many other countries have
provided government funds.
– Private companies have
invested in stem cell research.
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California
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• California has its own stem cell research funding agency:
The California Institute for Regenerative Medicine
(CIRM).
• In California law, people who contribute eggs or embryos
to stem cell research cannot receive any valuable
compensation in return.
• This also means that researchers
funded by CIRM cannot use
stem cell lines where a donor has
been compensated.
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New York
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• New York also has its own stem
cell regulations: the Empire State
Stem Cell Science Board.
• Under New York regulations it is
legal to financially compensate
women who give their eggs to stem cell research.
• This means that researchers in New York can also use
lines derived from embryos or eggs where the contributor
has received valuable compensation.
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Discussion Question
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You are the head of a small stem cell lab at a public
university in California. You want to enter into a research
collaboration with another lab located in Iowa. What factors
do you need to consider before going forward? What
information do you need and where would you go to get it?
Discuss these questions with your neighbor and then share
with us.
13
Research Oversight
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The NAS guidelines recommend that any institution that conducts stem
cell research should have a Stem Cell Research Oversight
Committee (SCRO).
• “Ensure that inappropriate research is not conducted and that controversial
research is well justified and subject to appropriate oversight”
• Members are expert in developmental biology, stem cell biology, assisted
reproduction, patient advocacy, community relations, law and ethics.
Special status of the human embryo demands
• Scientific rationale for the need to generate new lines and a basis for the number
of embryos and oocytes needed
• Implantation of human embryonic stem cells into nonhuman animals raises
ethical concerns
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Research Oversight
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• The NAS guidelines recommend that any institution that
conducts stem cell research should have a Stem Cell
Research Oversight Committee (SCRO).
• SCROs are comprised of experts in developmental
biology, stem cell biology, assisted reproduction and ethical
and legal issues.
• The job of the SCRO is to provide an outside perspective
on research to ensure compliance with policies and help to
minimize the unnecessary use of scarce resources.
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Research Oversight
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• Most SCROs review research which involves
– the use of human embryonic stem cells or their derivatives,
– the introduction of human pluripotent stem cells, or their
derivatives, obtained from a
non-embryonic source, into
non-human animals at any
embryonic, fetal, or postnatal
stage, if an expected effect is
that human cells will be integrated
into the central nervous system,
testes, or ovaries of the animal.
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What do SCROs look for?
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• What is the provenance of the cells?
• Are they “ethically derived”?
• Can this research be done with fewer embryos or animal
models?
• Are the research donors adequately protected?
• Is their personal information ascertainable by the researchers?
• Did the gamete or embryo donor give their informed consent?
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What’s off limits?
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1. Any culture of an intact human embryo for longer than 14
days
2. Research in which hESCs are introduced into nonhuman
primate blastocysts or in which any embryonic stem cells
are introduced into human blastocysts
3. No animal into which hESCs have been introduced should
be allowed to breed.
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Case Study: Colonel Sanders
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Colonel Sanders, MD
Research protocol Summary*
1. Sanders plans to put human embryonic stem
cells into a chick embryo.
2. wants to study how embryonic stem cells
contribute to the development of limbs.
3. Has experience using human embryonic stem
cells.
4. Using embryonic stem cells listed on the NIH
registry.
Should you approve the protocol? What or why
not? Would you request any changes to the
protocol?
Finger Lick’n Good!
*Adapted from: Zettler P, Wolf L, Lo B.
Establishing Procedures for Institutional Oversight of Stem Cell19
Research.
Academic Medicine, V82, No. 1 2007)
Human Subjects Research
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• If stem cells will be placed in patients, the research must
be reviewed by an Institutional Review Board (IRB).
• The IRB ensures that participants are adequately informed about
the research and that the risks are acceptable.
• According to Federal policy, participation in human
subjects research must be free from coercion.
• Vulnerable populations must be given extra
consideration.
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Hwang Woo-Suk
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Cloning!
• South Korean scientist Hwang WooSuk announces that his team has
successfully started a human
embryonic stem cell line using the
nuclear transfer technique with
human eggs.
• Extracting human eggs is painful and may be dangerous to the
woman. She must take high-dose hormones which may have long
term effects on her health.
• Hwang’s paper in Science reports that they used 242 human eggs to
get one stem cell line.
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Hwang Woo-Suk
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Fraud!
• Nature reporter raises questions
about where the eggs came from.
• Junior scientists begin to question
specific items in Hwang’s articles.
• Research actually used 2,061 eggs over a 3-year period. Many women
were paid $1500 to give their eggs. Two junior lab members were
pressured into giving their eggs. Not all of the women understood
the risks of egg extraction procedures.
• PLUS one of Hwang’s team admits he faked the 9 of the 11
reported lines.
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Professional Ethics
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What does it mean to have scientific ethics?
• Scientists must have integrity. They must only
publish data which they believe to be true.
• Individuals must be given credit for their work.
The assignment of authorship should be fair.
• Individuals listed as authors on a paper must have
contributed significantly to its content. It is
wrong to offer credit on a paper in exchange for
something else.
• Scientific conclusions must be supported by the
data, not the opinions or goals of the researcher.
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Professional Ethics
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• Violating scientific ethics is not against the law in
most places BUT it can have serious consequences.
– Scientific journals require professional ethics.
• Hwang’s papers were retracted.
– Employers should require professional ethics.
• Hwang was fired and his lab closed.
– Your colleagues require professional ethics.
• Hwangs collaborators and team members denounced him.
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Discussion Question
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State and federal regulations/policies need to strike a balance
between protecting the rights and health of citizens and
allowing/supporting scientific research and advancement.
At this point in time, do you see the regulations as weighted
more to one side or the other? What regulations or policies
may be too stringent? Too lax? Explain why.
Discuss these questions with your neighbor and then share
with us.
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Summary
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What does this mean for you?
• You must respect the principles of research
ethics in all of your work.
• You should also maintain professional integrity.
• Regulations and policies about stem cell
research are very different depending on which
country and state you are in.
• When in doubt, you should consult your IRB or
SCRO about the relevant regulations and policies.
• If you do not have a review board, you may try
seeking legal counsel.
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Case Study: Professor Plum
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Professor Plum, PhD
embryonic stem cell researcher
Research protocol Summary
1. She wants to put neural cells made from human embryonic stem cells
into chimpanzees with damaged brains.
2. She plans to study whether the cells can repair or renew the damaged
tissue.
3. Plum is a seasoned cell biologist, but has no experience using human
embryonic stem cells.
4. Her research plan states the embryonic stem cells came from a
German lab, and the Germans got the cells from Israel.
Assignment
Work with your policy stakeholder partner over the weekend
On Tuesday, we’ll deliberate and vote in committee
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