Biomedical Engineering Reference
In-Depth Information
the best available factual information and that the decision
maker be honest about what is not known.
Next, use the gathered information to identify
realistic options and alternate solutions. Conduct a sen-
sitivity analysis, i.e., compare how each alternative per-
forms in terms of how sensitive it is to slight changes in
scenarios needed to reach the decision. For example, one
alternative may produce excellent outcomes (high on the
utility scale), but in the process it leads to injustices or
disproportional harm (low on the fairness scale). The
alternative of withholding scientific findings that may
promote bioterrorism (i.e., ''dual use''), for instance,
could be seen as one where one utility is optimized (i.e.,
security), but at the expense of another value (i.e., sci-
entific freedom). Based on these analyses, a number of
plans for addressing the problem can be considered.
All the reasonable plans can be compared and assessed
against moral metrics, such as those embodied in the
moral theories (e.g., utilitarianism, Rawlsism, deonto-
logy, and rational models). Key to these assessments is
characterizing all the potentially affected parties and the
stake each has in the decision. What are the risks and the
benefits to each party from each option?
Finally, make a well-informed decision. However,
even after the decision is made, keep seeking feedback
and revisiting the options and alternatives to ensure that
the decision continues to be the right one. Ethical de-
cision making can be messy and chaotic. Unanimous
decisions are the exception. Even consensus can be dif-
ficult. Sometimes, the right decision is made in the face
of a resistant majority. So, the process is never static and
the actions may need to be adapted as new information
becomes available. For example, the constraint may dis-
appear. The choice of keeping some lead (Pb) in gasoline
even though it was known to have neurotoxic effects
eventually went away in the 1980s when alternative fuel
additives became available and when engines were
redesigned. Or, when a sufficient repository of data be-
comes available, the need for even important animal
testing can be replaced by computational methods (i.e.,
in silico studies and informatics). Thus, we need to
continue to look for alternatives to animal research.
Animal welfare is sometimes categorized as the ''3 Rs:''
Genetically modified organisms
Genetic modification of organisms is a very old endeavor.
Humans have changed the characteristics of numerous
plants and animals through selective breeding techniques,
beginning with attempts to encourage offspring from or-
ganisms with favorable traits, such as size, color, texture,
and taste. However, in recent decades the process has
become supercharged with the onset of direct genetic
manipulations of DNA and RNA. Like a number of bio-
ethical issues, genetic manipulation is associated with the
slippery slope fear. 26 The slippery slope occurs when
allowing an act makes it ''impossible to hold the line and
prevent extension to a less justifiable situation.'' 27 The
goal of genetic modification is to delete specific pheno-
typic characteristics from or introduce new characteristics
to an organism's progeny. Prior to the late twentieth
century, this was done externally, but now it is increasingly
accomplished internally within the cell's genetic material.
The resulting progeny is known as a ''transgenic organism.''
Transgenesis occurs when DNA from another organism is
introduced using artificial gene transfer techniques.
Such techniques allow researcher to understand the
interactions of certain genes more completely. The major
ethical issues involved in genetically modified organisms
(GMO) often center on animal welfare, and risks to human
health and environment. For example, what if a new
creature is so different in kind that it has such a competi-
tive advantage (i.e., no effective predators) or an ability to
self-replicate that it would pose risks to public health and
welfare, in violation of the engineer's first ethical canon.
And, how many animals' lives are worth an important
discovery? Are we decreasing the genetic diversity of our
wildlife or destroying the habitats of other animals?
Such concerns come from within and outside of the
scientific community and have at least a basis in utili-
tarianism (i.e., disagreement about the utility versus
risks). Others oppose the research based on religious and
moral concerns, arguing that the researchers and the
biotechnological companies are immorally attempting to
''play God'' by creating entirely new beings and un-
naturally altering the genetic makeup of progeny.
Furthermore, GMOs are generally supported due to the
dual effects principal. First, it is believed that such re-
search could lead to more profitable or productive animals.
Second, scientists hope that this experimentation could
aid humans by developing treatments to deadly diseases or
methods to assist in the creation of tissues and organs.
1. Reduction. Methods that result in the use of fewer
animals to obtain scientifically valid information.
2. Refinement. Methods to reduce stress or discomfort
to the animals involved and to improve animals'
overall well-being and environment.
3. Replacement. Methods other than animal studies that
can provide robust biomedical information and
modeling.
Transgenic species
An organism that has been genetically modified (GM) is
known as a ''transgenic species.'' There are at least two
ethical considerations of transgenic species. First, what
The bioengineering researcher must constantly re-
think the research to adhere to these three methods.
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