Transcript 4.1 Socio-cultural Level of Analysis: Socio

Discuss ethical considerations in research
into genetic influences on behavior?
Things to consider….
Advances in human genetic research hit the
headlines every day in our world.
 The Human Genome Project, cloning people,
“gay” genes, genes for alcoholism and
cancer are all daily fare for the media. We
live in a “genetics world”.
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It is critical that genetic research is carefully
guided by strict and specific ethical
guidelines.
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The review of genetic research is becoming
an increasingly important aspect of the work
of human research ethics committees.
An important thing to remember when
considering genetic research is that genes
themselves do not cause disease, but
alterations to the usual gene sequence may
lead to disease. Why is this important to
consider when dealing with genetic
behavioral research?
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It would be over-simplistic to assume that all
disease is due purely to our genetic make-up.
Some scientists, and the media, can polarize
towards ‘genetic determinism’, assuming that a
person is merely the sum of his or her genes.
However, a person’s current and future health is
the interaction of many factors, including
environment and lifestyle, genes and interaction
between the two. Thus, one cannot approach
genetic research with the assumption that genes
are 100% of any problem.
Consent and recruitment of research subjects
 Confidentiality, privacy and security
 The potential benefits and harms of human
research involving genetic testing
 The interface between research and clinical
practice
 The future use of samples
 Vulnerable groups
Note: This list is not compulsory and thus it should
be noted that several other considerations exist.
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Researchers should always pay particular attention
to ensuring that potential research subjects are
adequately informed in an accessible and
understandable way about the goals of the study,
what their participation entails, and possible harms
and benefits of participation. This should be the
case in all research at any level of analysis.
In a genetic study specifically, they should also
know how their privacy and confidentiality will be
protected, and what will happen to any genetic
material or information obtained as part of the
study. People have a right to know whether their
access to insurance or employment could be
compromised in any way by genetic data that are
generated.
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Recruitment and enrollment of both
affected and unaffected family members
might in some cases pose a threat to the
usual relationship between a clinician and
patient.
An example of this might be where a
patient comes to suspect, rightly or
wrongly, that a clinician is more
concerned with a successful research
outcome than with the patient’s care.
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Most genetic research involves patients and
family members. Thus, special consideration must
be made for family members of patients.
In a genetic study, researchers should pay
particular attention to the method by which family
members are to be approached and by whom a
family member will be contacted.
It is generally accepted by genetics researchers
and clinicians that it is best for potential research
subjects to be contacted by someone they know
and are likely to trust. In many cases this will be a
family member.
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Sometimes this may make potential participants
vulnerable to pressure to participate from other family
members, and conversely, if there are family disputes it
may be less likely that members will be recruited for
valuable research.
These considerations sometimes suggest that it may be
better for research subjects to be recruited by health
professionals or suitably qualified researchers.
Whatever approach is adopted, it is important to
confirm that researchers have considered possible
difficulties and have thought about the issues.
Subjects should be recruited as individuals in their own
right rather than as a family group, and should consent
as individuals.
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Given the familial nature of genetic research,
confidentiality, privacy and security are
important considerations in ethical review of a
genetic study.
The seriousness of the consequences varies
both between conditions and individuals.
Genetics research can sometimes, either
directly or by implication, reveal private
information to one individual about other
members of their family.
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It might reveal information about health status
either through discussion of the result of a
genetic test or in the process of collecting
information for the construction of a family
pedigree.
A research subject may read or deduce
information provided by other family members.
Such information may be disclosed by
accident through questions asked by a
researcher about the family history.
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Accidental disclosure of such information can
have consequences for the broader family and
for one person’s relationships with other family
members.
It may be revealed later by one family member
to another during a family conflict, or may itself
become the subject of a dispute. Care should
be taken to ensure that safeguards are in place
to avoid this outcome.
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As in the review of all medical research, committees
have to assess the potential benefits and harms of the
project under consideration.
Genetic research will, in all probability, bring great
benefits to human health. One benefit that some genetic
studies offer is information about susceptibility to disease,
and precautions that can be taken to prevent disease.
Another important benefit can be knowledge about risk
of having a child with a genetic condition and strategies
one can employ to avoid having a child with a genetic
condition (adoption, prenatal testing or pre-implantation
genetic diagnosis).
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Possible psychosocial harms might include fear of discrimination or
stigmatization. Research subjects may also become anxious about
the implications of test results for insurance, for their future
relationships or for future reproductive choice.
In other cases, such as genetic research in psychiatry, research
subjects may come to feel that their involvement will lead to social
stigmatization or family rejection. Even where the likelihood of such
harms might appear to be minimal, consideration may need to be
given to the need for advice and counseling to research
participants.
Many genetic studies should consider making the services of a
genetic counselor available to participants who request this
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In addition to these psychosocial harms, participation in
a study may leave subjects and their relatives open to
stigmatization in a variety of ways.
Discrimination may occur within the family itself, with
affected family members rejected by other family
members. In some cases genetic information will have
the potential to affect a person’s future relationships, or
their perceived suitability for marriage. What examples
can you think of where this would happen?
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Genetic research can reveal unexpected information,
that may be a source of harm to research subjects,
particularly if this possibility is not discussed when
obtaining consent.
Examples include misattributed paternity or ‘secret’
adoptions within a family.
Another example occurs when a family member offers
to participate in a study believing s/he is unaffected,
and discovers from the study that he or she carries the
altered gene but has no signs of the disorder.
A+ Info on IEC Manual
http://www.uq.edu.au/oppe/P
DFS/IEC_Manual.pdf
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The Human Genome Project was completed in
2003. One of the key research areas was ethical,
legal, and social issues research (ELSI).
The U.S. Department of Energy (DOE) and the
National Institutes of Health (NIH) devoted 3% to 5%
of their annual Human Genome Project (HGP)
budgets toward studying the ethical, legal, and
social issues (ELSI) surrounding availability of
genetic information.
This represents the world's largest bioethics
program, which has become a model for ELSI
programs around the world.
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The ethical issues raised by the human genome project
can be grouped into two general categories: genetic
engineering and genetic information.
The first category consists of issues pertaining to genetic
manipulation or what is sometimes called “genetic
engineering.”
The map of the human genome provides information
that will allow us to diagnose and eventually treat many
diseases. This map will also enable us to determine the
genetic basis of numerous physical and psychological
traits, which raises the possibility of altering those traits
through genetic intervention.
Reflection on the ethical permissibility of genetic
manipulation is typically structured around two
relevant distinctions:
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The distinction between somatic cell and germ
line intervention, and
The distinction between therapeutic and
enhancement engineering
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Somatic cell manipulation alters body cells,
which means that resulting changes are limited
to an individual.
In contrast, germ line manipulation alters
reproductive cells, which means that changes
are passed on to future generations.
What ethical issues can rise from germ line
manipulation?
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Therapeutic engineering occurs when genetic
interventions are used to rectify diseases or
deficiencies.
In contrast, enhancement engineering
attempts extend traits or capacities beyond
their normal levels.
What ethical issues can rise from genetic
engineering?
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Germline interventions involve more significant
ethical concerns, because risks will extend
across generations, magnifying the impact of
unforeseen consequences.
While these greater risks call for added caution,
most ethicists would not object to the use of
germline interventions for the treatment of
serious disease if we reach the point where
such interventions could be performed safely
and effectively.
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Indeed, germline interventions would be a more
efficient method for treating disease, since a single
intervention would render both the patient and his
or her offspring disease-free, thus removing the
need for repeated somatic cell treatments across
future generations.
Enhancement engineering is widely regarded as
both scientifically and ethically problematic. From
a scientific standpoint, it is unlikely that we will soon
be able to enhance normally functioning genes
without risking grave side effects. Would the
benefit of enhancement engineering to genes
outweigh the cost? Why or why not?
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Enhancing an individual’s height beyond his or her
naturally ordained level may inadvertently cause
stress to other parts of the organism, such as the
heart.
Moreover, many of the traits that might be
targeted for enhancement (e.g., intelligence or
memory) are genetically multifactorial, and have a
strong environmental component. Thus, alteration
of single genes would not likely achieve the
desired outcome. These problems are magnified,
and additional problems arise, when we move
from somatic cell enhancements to germline
enhancements.
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In addition to the problem of disseminating unforeseen
consequences across generations, we are faced with
questions about whether future generations would
share their predecessors’ views about the desirability of
the traits that have been bequeathed to them.
Future generations are not likely to be ungrateful if we
deprive them of genes associated with horrible
diseases, but they may well feel limited by choices we
have made regarding their physical, cognitive, or
emotional traits.
In short, there is a danger that social-historical trends
and biases could place genetic limitations on future
generations. Do you agree or disagree with this
assertion?
A+ info on HGP ethical considerations
http://www.actionbioscience.org/genomic/carroll_ciaffa.html