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BIOMEDICAL ENGINEERING ETHICAL DILEMMA
Harry Volek (hjv5@gmail.com)
DILEMMA
I am a biomedical engineering developing a superior
design for the electrode used in Deep brain stimulation
treatment. There is a significant amount of data that shows
this new design will reduce the symptoms of Parkinson’s
and similar motor diseases to almost nonexistent levels. The
product has been green-lighted for human trials. The trial
will be a double blind, placebo controlled surgical
experiment, meaning that the subjects will not know if they
have undergone an actual surgery or a placebo surgery, and
the surgeons will not know if the subject is going to receive
the actual surgery until the surgery begins.
One day, while preparing for the upcoming clinical trial,
my supervisor approaches me. He says he was able to pull
some strings to get his friend suffering from Parkinson’s
entered in to the trial. However, he needs one of the trial
workers to ensure that his friend receives the actual surgery.
My supervisor goes on to say that this new design will
greatly improve his friend’s quality of life, and due to the
rate at which his symptoms are increasing he cannot afford
to wait for the product to move past human trials. Double
blind studies are performed to eliminate bias from the data,
thus any action done to alter the trial may ruin the data. My
supervisor knows what is at stake, but he offers me $2000 to
help out his friend.
ETHICS OF CLINICAL TRIALS
A great deal of effort is put into keeping clinical trials
ethical, most of all human trials, and for good reason.
During World War II, Nazi physicians and scientists
performed medical research experiments on thousands of
unwilling prisoners of war, many of whom died or were
permanently injured as a result [1]. The disregard of human
life shown by these physicians in the name of scientific
research was given international attention at the post-war
trials at Nuremburg. These trials lead to the creation of a set
of guidelines that outline ethic principles for human trials,
called the Nuremburg Code.
In 1953 the National Institute of Health began requiring
that all clinical research projects received approval from a
review panel. These review panels, called Institutional
Review Boards, must consist of at least five people that
include both males, females, individuals with scientific
interest, and individuals without scientific interest. The
Institutional Review Board, or IRB, reviews the material and
its members meet to determine whether the trial follows the
appropriate ethical standards. If the trial is approved, the
IRB monitors its progress as appropriate, typically on at
University of Pittsburgh, Swanson School of Engineering 1
Submission Date 2014-10-28
least an annual basis. They also monitor any adverse events
that occur during the course of the trial.
There are six ethical principles that the Institutional
Review Boards look for [2]. These six principles are the
value of the trial, the scientific validity, fair subject
selection, favorable risk-benefit ratio, informed consent, and
respect for enrolled subjects. The value of the trial means
that clinical trials must be done for the purpose of furthering
healthcare or science. Scientific validity means the research
must be methodically vigorous. In order to decide upon a
course of action based on ethics, I must consider both the
ethics of the trial itself and the ethical code of engineers.
CODE OF ETHICS
Engineering is a learned profession of great importance
in society. Engineers have a direct impact on the quality of
life for all people, and as such are expected to exhibit the
highest standards of honesty and integrity [3]. Engineers
must be held to a standard that includes the highest
adherence to ethical conduct. The NSPE Code of Ethics for
engineers has six fundamental canons that summarize the
essence of the code [3]. These six canons are to hold
paramount the safety of the public, perform services only in
areas of expertise, issue public statements only in an
objective and truthful manner, act for each client as a trustee,
avoid deceptive acts, and to conduct yourself honorably.
Biomedical engineers have a more specific code of ethics
that must be followed in addition to the general code of
ethics. The Biomedical Engineering Society Code of Ethics
includes
the
responsibility to
maintain patient
confidentiality, to consider the larger consequences of their
work in relation in health care, and to comply fully with
legal, ethical, institutional, governmental, and other
applicable research guidelines [4].
It is easy to understand that following the code of ethics is
of the upmost importance. However, despite its best efforts,
there is still ambiguity within the code that leaves room for
ethical dilemmas. For example, the code of ethics states that
engineers have a responsibility to both the public and the
employer. This raises the question of who does the engineer
answer to first? Section II.1.a. of the code states that “If
engineers' judgment is overruled under circumstances that
endanger life or property, they shall notify their employer or
client and such other authority as may be appropriate” [3].
However, this still requires the engineer to determine if the
situation will endanger the life or property of civilians before
employer confidentiality is allowed to be broken.
The actions of biomedical engineers have an even more
direct effect on the lives of the population than most other
areas of engineering, as biomedical engineers work on
Harry Volek
products and methods to improve the health of patients
directly. This increases the tension of the engineer’s required
loyalty to their employer and the engineer’s loyalty to the
patient. New dilemmas unique to biomedical engineers
appear, such as if a biomedical engineer designing a medical
tool had to decide between using two materials, one is
disposable but will sell better in the United States, the other
is more durable and can be reused by doctors in third world
countries, what material should he choose [5]? The
Biomedical Engineering Society Code of Ethics states that
biomedical engineers must consider the larger consequences
of their work in regard to cost, availability, and delivery of
health care [4], but engineers must also follow their
employers wishes.
Above I have stated the complicated nature of the loyalty
expected of engineers to both the employer and the public.
This concept is the cause of the dilemma in the clinical trial
for the new Deep brain stimulation, or DBS, electrode
design. First, accepting the bribe the supervisor offered is a
violation of the fifth fundamental canon of the NSPE Code
of Ethics, which states to avoid deceptive acts. The more
troubling component of the ethical dilemma is whether to
ensure the supervisor’s friend receives the actual DBS
surgery. Biomedical Engineers have a responsibility toward
their patients, as stated in the biomedical engineering code
of ethics. Ensuring the patient receives the treatment he
needs also upholds the first fundamental canon of the code
of ethics. Tampering with the trial in favor of one patient
will at most only minimally affect the results. In addition,
the supervisor is overruling my judgment under
circumstances that do not endanger life, so Section II.1.a
does not give me the power to notify an authority.
While the Code of Ethics can be viewed as in favor of
tampering with the trial, the biomedical engineer code of
ethics states that biomedical engineers must consider the
larger consequences of their work; tampering with the
clinical trial could prevent the product from becoming
available to the general population. For complicated ethical
situations such as this, there are a multitude of public case
studies that can be reviewed.
his lab. The first person the researcher interviewed is named
Brenda Roberts. Brenda works at a lab owned by a
prestigious medical school. She states that while working
she routinely touches the chemicals without gloves, and that
the ethidium bromide in the researchers lab is too diluted to
cause harm. Brenda was the most experienced researcher
the writer interviewed, and the writer mentioned she was
still concerned about safety. Brenda states that people who
are very cautious in labs are inexperienced because they
have not learned to take the risks yet [6].
The author of the case study interviews several other
people, but the only other person interviewed with enough
research experience to match Brenda Roberts is Paul Davis.
Paul Davis works in a biomechanics lab that is designing a
new drug that prevents osteoporosis [6]. Paul enforces all lab
protocols, requiring all lab employees to wear gloves,
googles, a face mask, and a long gown. Prior to his current
job, Paul dealt with ethidium bromide and took the author’s
situation very seriously. Paul states that when dealing with
ethidium bromide gloves must be worn and the substance
must be disposed of in collection jars, no matter what the
chemical’s dilution is.
These two experienced laboratory workers have opposing
stances about lab protocol. Brenda believes that practicality
takes precedence over the rules, as she knows that the
amount of ethidium bromide dealt handled in the author’s
laboratory is not enough to cause any harm, even if handled
without gloves. Paul believes that in order to have a safe
work environment, safety procedure must be followed to the
letter. This includes using gloves and special disposal
containers for substances that cannot realistically harm the
lab worker.
While it may be easy to take the side of Paul, Brenda is an
experienced lab worker with years of experience, meaning
she understands the dangers of ethidium bromide and knows
what she needs to do to be safe. This is similar to my
dilemma, because although messing with the bias of the
double blind study may slightly tamper the results, ensuring
that one person does not receive the placebo will not ruin the
trial from a statistical standpoint. If I understand the danger
and the effect my actions will have on the trial, like Brenda,
I can break the guidelines and help my supervisor’s friend
without consequence.
On the other hand, Paul Davis is also an experienced lab
researcher, yet he follows the guidelines precisely. Paul
knows that if he does not follow the rules, then lab workers
under his care have the freedom to not follow the rules,
destroying the credibility of the laboratory. If I decide to
tamper with the data of the clinical trial to any degree, I
destroy the credibility of the trial.
The ethidium bromide case study is a great reference to
laboratory ethics, but the study deals with chemicals, not real
patients, or employers assigning unethical tasks to their
employees. Are engineers obligated to perform unethical
tasks if their employee asks it of them? The NSPE Board of
Ethical Review reviewed a case in which a fire protection
CASE STUDIES
A case study is a descriptive, exploratory, or explanative
analysis of an event that is used to find underlying principles.
Case studies of past events can be used to determine a course
of action for a current event. In particular, I should reference
case studies pertaining to adherence to protocol in
laboratories and studies that deal with the safety of civilians
against the confidentiality of the employer.
In one case study, researcher at a laboratory noticed his
coworkers ignoring protocol and touching ethidium bromide,
a strong carcinogen, with their bare hands [6]. Instead of
contacting a superior, the researcher decided to ask other
scientists about what they thought of the safety practices in
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Harry Volek
engineer performed an evaluation of a building for a client
[7]. The engineer told the client the building was in violation
of the local fire code, and the client made it clear he was not
going to repair the building. The engineer was then paid for
his services and went on his way. The NSPE Board of
Ethical Review found the engineer’s actions unethical
because no report was made to an authority [7].
Going off of the conclusion the NSPE board reached, the
ethical course of action for me would be to tell my
supervisor that the clinical trial should not be tampered with.
If my supervisor continues to attempt to bribe me, I would
then be required to bring the issue to a higher authority.
REFERENCES
[1] “The Ethical Oversight of Clinical Trials: Institutional
Review Boards” Medmarc (online article).
http://www.medmarc.com/Life-Sciences-News-andResources/Articles/Pages/The-Ethical-Oversight-of-ClinicalTrials.aspx?gclid=CjwKEAjw2reiBRCaobK3udOjQ4SJACXWyYmkODELHSHYKWqTk73WF_zevEMapV
E-jilFrRa8TYeAxoCT4jw_wcB
[2] E. Emanuel, D. Wendler, C. Grady. (2000, May 24).
“What Makes Clinical Research Ethical?” American
Medical Association (Journal) .
http://www.dartmouth.edu/~cphs/docs/jama-article.pdf
[3] (2007, July) “NSPE Code of Ethics for Engineers” NSPE
(online article).
http://www.nspe.org/resources/ethics/code-ethics
[4] (2004, February) “Biomedical Engineering Society Code
of Ethics” Biomedical Engineering Society (online article).
http://bmes.org/files/2004%20Approved%20%20Code%20o
f%20Ethics%282%29.pdf
[5] G. Crevensten (1995, May) “Motivation and Scenario:
Research Safety in Laboratories" Online Ethics Center for
Engineering (case study).
http://www.onlineethics.org/Resources/Cases/labtox/labmotivation.aspx
[6] “Case 10 - Third World Considerations” Stanford
Biodesign (case study).
http://biodesign.stanford.edu/bdn/ethicscases/10thirdworld.js
p
[7] (2013) “Public Health and Safety- Delay in Addressing
Fire Code Violations” NSPE (case study)
http://www.nspe.org/sites/default/files/BER%20Case%20No
%2013-11-FINAL.pdf
[8] H. Weinel (2014, August 2). Conversation
[9] (1978) “The New International Version Bible” Bible
(print).
OUTSIDE INFLUENCES
Ethics and morals are both very similar concepts relating
to right and wrong. Like morals, ethical inspiration can
come from very non-traditional places. One of the people I
turn to when faced with complicated decisions is my friend
Hunter. Hunter is a person with very strong convictions
when it comes to the health and safety of other people.
During the summer he works as a lifeguard at his local pool,
and has had to rescue multiple people. When asked about
whether he would guarantee the treatment of one person
while risking the trial, he told me he would not do it, even if
he was bribed. His reasoning is that if the product can really
help people, it is not worth risking its credibility over one
person [8].
As a Christian, another place I turn to for help with tough
decisions is the bible. There is a plethora of bible verses that
can be looked to in tough situations, but a favorite of mine is
Luke 6:31, “Do to others as you would have them do to you”
[9]. I know that personally I would not want somebody to
guarantee a treatment in return for risking the entire trial.
All patients who sign up for a clinical trial agree to the
conditions of the trial, and for double-blind trials the
condition includes the possibility of receiving a placebo.
ACKNOWLEDGEMENTS
RECOMMENDATIONS TO ENGINEERS
I would like to thank my parents for supporting me, and I
would like to thank my fellow freshman engineering friend,
Courtney Vu, for helping me work out my ideas for the
paper.
Engineers have a duty to both their employer and the
public, as well as a duty to act in an honest and professional
manner. Engineers, in particular Biomedical Engineers,
must consider the greater consequences of their actions. In
this clinical trial dilemma the only way to act ethically is by
declining the offer of the employer, and talk to a higher
power about the supervisor’s intentions if the supervisor
refuses to give up. Accepting the supervisor’s offer will
destroy the credibility of the trial and prevent people
suffering from the symptoms of Parkinson’s and other motor
diseases from getting the help they need.
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