Budny 10:00
L06
MY ETHICAL DILEMMA INVOLVING CLINICAL TRIALS FOR THE
ARGUS II RETINAL PROSTHESIS SYSTEM
Kate Lundy (kal176@pitt.edu)
INTRODUCTION
Engineers have the power to shape our future. Their
innovations determine how we as a society live our lives. The
whole community depends on and has to put their trust into
the engineers’ ability to create functioning methods,
technology, and structures which our lives revolve around. In
order for engineers’ designs to operate smoothly, engineers
must be logical, careful, and thorough. Although it is
important for them to work methodically, it is crucial that they
also work ethically. Engineers have a great amount of power,
for their decisions can affect many people’s lives; with great
power comes great responsibility. Therefore, it is important
that all engineers work in the best interests of society.
As a biomedical engineer, I feel as though it is my duty to
keep the public healthy and safe. In order to do this, I must
have standards that guide my decisions. Although I am
generally confident in knowing what is right or wrong, there
are times when I am faced with ethical dilemmas. In these
situations I have to view my options and weigh out the pros
and cons of each one in order to come up with an action plan
that I feel comfortable with.
MY SCENARIO
Recently I have been faced with an ethical dilemma in my
engineering field. For the past few months, my company,
BioTech, has been trying to recruit patients for a clinical trial
in order to test out the effectiveness and symptoms of the
Argus II Retinal Prosthesis system. This new device is the
first implanted technology to help adults with severe retinitis
pigmentosa, which is an inherited disease that causes
blindness due to the degradation of photoreceptors in the
retinas [1][2].
Before my company began to search for patients to enter
our study, my boss, Dr. X, has taught me and my fellow
colleagues the specific procedure we need to follow in order
to decide whether or not a patient is acceptable for the clinical
trial. More specifically, we need to make sure each patient fits
a list of requirements. These included being at least 25 years
of age, diagnosed with retinitis pigmentosa, have had some
type of vision, having little to no light perception, no
electroretinographic response, and functional ganglion cells
or optic nerve [2][3]. Patients were not recruited if they had
any disease that “affected retinal or optic nerve function,
ocular structures, or conditions that could prevent successful
implantation, and any inability to tolerate the implant surgery
or medical/study follow-up” [2]. My boss made it very clear
about the importance of following the protocols, for straying
University of Pittsburgh, Swanson School of Engineering 1
2015-11-03
from them could affect the validity of the trial and risk the
patients’ health. After going through the training process, I
felt comfortable and confident in finding qualified candidates
for our study.
As our enrolling process began, Dr. X informed us not to
expect many contenders for our trial. He explained that
retinitis pigmentosa is a rare disease only affecting about 1 in
4000 people [4]. Furthermore, not everyone who qualifies
may want to be a part of the study.
However, the recruiting process was even slower than my
boss expected. As months went by and fewer people qualified
or were willing to participate in the trial, Dr. X was getting
more and more anxious. A couple of times I overheard him
talking to other coworkers about our slow situation and I
could hear the frustration in his voice. One time I even heard
him mumbling to himself about thinking of other possible
ways to get more people into the trial. At the time, I didn’t
think much of it because of course all my colleagues and I
were thinking and wishing we could start the trial soon, but
that didn’t mean we were going to bend the rules in order to
do so.
My ethical dilemma came about when my boss recruited
three patients in a week, which was a huge jump from our one
or maybe two recruits in a month. Two of the patients he took
in were two that I interviewed and didn’t think fit the strict
requirements for the clinical trials. When I told Dr. X I already
looked at the patients, and thought they weren’t eligible, he
told me he double checked all the patients and assured me that
when he looked over their credentials, they fit the
requirements. I began to doubt myself and I immediately
thought I must have read something wrong or missed an
important detail in the patients’ data. I have known my boss
for quite a while and have always looked up to him as a
professional, intelligent, and ethical engineer. Although I had
great confidence that my boss would not just accept patients
who weren’t qualified into his clinical trial, something didn’t
feel right. In my head, I went over my interviews with the
patients and tried to remember going through their papers that
I believed showed their incompatibility with our trial. The
more I thought about it, the more I felt uneasy and questioned
my boss’s actions, for I was sure I didn’t misjudge any of the
data. I then decided to look at the facts instead of relying on
my memory. I gathered the data I collected for the two
patients and reviewed them. I couldn’t find any mistake my
boss claimed I’ve made.
I was then faced with a new challenge: what do I do now?
Do I let it go and ignore the fact that my data doesn’t match
my boss’s conclusion? Do I show Dr. X my data and confront
him? Do I tell the patients they should withdraw from the
study? Millions of questions, plans, and outcomes were
Kate Lundy
rolling through my head. I needed to find some guidance as to
what I should do.
to potentially benefit a group of people in the long run [5].
Furthermore, all the patients in the Alzheimer clinical trial
were eligible to be in the trial and the questionable ethical
misconduct was later in the process of the trial [5].
Contrastingly, my company hasn’t begun the clinical trial and
the unethical action affects the set-up of the study, which
invalidates a bigger portion of the trial. Even though there are
some differences, in both cases data was changed unethically.
In addition, the unethical decision in both scenarios could
affect not only the person who did it, but also their colleagues,
the organization they work for, the patients, and future
patients who may use the drug or device.
Grey faced several consequences as a result of her actions.
She was frowned upon by her colleagues, she was suspended
from her job, and her husband left her out of disappointment
[5]. Although these consequences may not be one hundred
percent realistic, the episode made it clear that things could
have turned out a lot worse and that some sort of consequence
will follow unethical behavior. Being able to watch how an
unethical situation unfolds, even if it isn’t completely
accurate, made me contemplate all the possible outcomes of
my boss’s action and the consequences along with it. I
imagined the FDA finding out about Dr. X’s action and
shutting down our trial, and possibly the company, leaving me
and my colleagues unemployed. I worried that even if we
weren’t caught by the FDA, all of the people who put their
trust into our invalid study would be affected and many
medical problems could arise. All of these concerns were
followed by the thought that I can’t let this happen.
SEARCHING FOR A SOLUTION
Over the following few days, I did some research on ethics
to help me figure out how to handle my situation. I looked at
factual sources that listed the codes of ethics in engineering
and magazines that talked about the importance of ethics. But
first, I turned to the T.V. series Grey’s Anatomy for direction.
Grey’s Anatomy Relates to My Situation
Although it is important to follow rules, ethical decisions
cannot just be determined by them. Ethics are not just black
and white where a set of rules can point out what is right and
wrong in every situation. A few Grey’s Anatomy episodes
that demonstrated a similar situation to mine reminded me of
this. In these episodes, Derek asks Meredith “How is it that
you don’t know the difference between right and wrong?” [5].
Without hesitation, Meredith responds “I don’t think thigs are
simply right or wrong. Things are more complicated than
that!” [5]. This discrepancy of legal ethics versus moral ethics
is why I decided to first take a look at Grey’s Anatomy before
reading the codes of ethics.
While I re-watched the episodes of Grey’s Anatomy that
pertained to my case, I kept in mind that it is fiction. However,
even though it is a fictional show, it has some realistic
elements and it also proposes some great ethical scenarios.
In the episodes I watched, the Seattle Grace Hospital
conducts a clinical trial for a new treatment to help
Alzheimer’s disease [5]. In order for the clinical trial to be
valid, patients are randomly assigned to either the
experimental drug or a placebo [5]. Adele, who is the wife of
Dr. Richard Webber, is a patient in the clinical trial and was
randomly assigned to get the placebo [5]. Knowing this, Dr.
Meredith Grey switches Adele’s envelope, which contains the
instructions to give Adele the placebo, for one that instructs
the surgeons to give her the experimental drug [5]. The
question then becomes whether Dr. Grey’s unethical decision
by law was in fact right or wrong.
I wasn’t quite sure if I agreed with Dr. Grey’s decision
until Alex, who witnessed Meredith’s unethical act,
confronted her and talked to her about the possible
consequences that she may face and how her action will affect
other people [5]. On one hand, she was helping a friend’s
loved one, but on the other, she invalidated the trial and as
Alex said, her actions changed “the life of the guy who was
supposed to get the drug and now won’t” [5]. Moreover, Alex
made the point that by illegally switching data in the trial,
Meredith risked all the doctors in the hospital being
blacklisted by the FDA [5]. These facts made it clear to me
that I didn’t agree with Dr. Grey’s decision
Grey’s situation isn’t exactly like mine. For one thing,
Grey tampered with the trial in order benefit a specific person,
where as in my case, my boss tampered with the data in order
The Ethical Laws Stated by the NSPE and BMES
After watching Grey’s Anatomy, I looked at more
professional sources to see if my feelings about Dr. X’s
behavior matched the rules of ethics in engineering. I read
over the National Society of Professional Engineers (NSPE)’s
and the Biomedical Engineering Society (BMES)’s codes of
ethics to familiarize myself with the laws of engineering
ethics and gain confidence in my beliefs. Within these sources
I found rules that applied to my situation and confirmed that
what Dr. X did was unethical. The first rule that stood out to
me was written in both the NSPE and BMES codes of ethics.
It stated that engineers must work in the best interest of the
public’s safety, health, and welfare [6][7]. As I read this, I
immediately asked myself if what my boss did was for the
“safety, health, and welfare of the public” [6][7]. Sure his
actions may have allowed the product to be available for
public use more quickly and potentially help many patients,
but his actions more likely would hinder the public because
the trial would be illegitimate. All the data would be skewed
and not accurately represent the Argus II Retinal Prosthesis
system’s effects on the patients who would actually be using
it out in the real world. To further emphasize the wrong doing
of my boss, the NSPE code of ethics clearly states that
engineers “shall not distort or alter the facts” [6]. If I don’t
take action, our clinical trial would be misleading and the
2
Kate Lundy
NSPE also notes, “Engineers shall avoid all conduct or
practice that deceives the public” [6]. After going through the
codes of ethics, I knew I must talk to Dr. X about his unethical
action and prevent unqualified patients from enlisting into the
trial, but I still didn’t know how to come about it.
Argus II’s future patients. I ended my argument with the fact
that speeding up the process of enrollment now is not going
to help the public, but instead only harm the public. Dr. X
responded by saying he would look into the patients data
again.
My speech must have reached Dr. X’s conscience
because the following day, he told me that he misread part of
his data and I was right that the patients were incompatible
with the trial’s strict requirements. He informed me that he
withdrew the patients from the study and thanked me for
approaching him with the concern.
The O Magazine Gives Me Confidence
I began looking through articles and magazines on ethics
to help me figure out how I should approach my situation.
One of the magazines I picked up was an old Oprah Magazine.
To my surprise, as I was flipping through the magazine, I
came across an article on ethics. This article not only stressed
the importance of ethics, but it also proposed how to train
yourself to do the right thing in ethical dilemmas [8]. The
method used is known as Social Fitness Training which
involves “role-playing morally challenging situations” [8].
According to this article, the most important part of the
process is to “identify the thoughts that might prevent [you]
from speaking up” [8]. I knew that I had many doubts about
confronting my boss, and was worried about what may
happen if I did. So, as suggested by this article, I jotted down
all the negative thoughts I was having.
I continued to read the article for more guidance, and at
the very end of the article, a five step process was given to
help people like me become more confident in having a tough
conversation with someone [8]. The steps were as follows:
One, describe your situation in a couple sentences and
imagine the discussion you must have with the person
involved in your dilemma [8]. Two, write down your thoughts
and doubts when thinking about having the conversation with
the other person [8]. Three, question each thought’s likeliness
of actually being true and list the possible outcomes that are
most probable [8]. Four, come up with positive things to say
to yourself as you start the conversation [8]. Five, visualize
and practice having the conversation in your head [8]. I
followed these steps, visualizing how I would approach Dr. X
and what I would say. I imagined as many possible outcomes
I could, good and bad, and I even rehearsed my speech in the
mirror until I felt confident.
ADVICE TO OTHERS
When faced with an ethical dilemma, it is hard to make a
decision that you feel confident in and comfortable doing.
Many engineers have faced pressing situations and had to
make the choice of acting or not acting. If you are faced with
a situation that makes you question what is going on, I
recommend first weighing out the pros and cons of doing
something about it versus just letting the situation go.
Furthermore, think about who is affected by the situation
directly or indirectly. If you choose to act and are having
difficulties coming up with something to say or are not sure
how to approach the other person in your situation, I would
suggest talking to a friend or family member about your
dilemma. Even talking in the mirror can inspire ideas of how
to start the conversation. Going through the steps proposed in
the Social Fitness Training program can also be beneficial.
Since engineers play such an important role in society,
they have a great responsibility to work in the best interest of
the public. People put their lives and trust into engineers’
hands, and engineers must work ethically to maintain their
trust.
REFERENCES
[1] FDA. (2015). “Argus II Retinal Prothesis System –
H110002.” U.S. Food and Drug Administration. (online
article).
http://www.fda.gov/medicaldevices/productsandmedicalproc
edures/deviceapprovalsandclearances/recentlyapproveddevices/ucm343162.htm
[2] A. Ho., et al. (2015). “Long-Term Results from an
Epiretinal Prosthesis to Restore Sight to the Blind.”
Ophthalmology.
(online
article).
http://www.sciencedirect.com/science/article/pii/S01616420
15004157
[3] S. Rizzo., et al. (2014). “12-Month Outcomes from a
Single-Study Center.” American Journal of Ophthalmology.
(online
article).
http://www.sciencedirect.com/science/article/pii/S00029394
14001032
[4] M. Jumper. (2013). “FDA Approves World’s First
Artificial Retina.” American Society of Retina Specialists.
MY DECISION AND THE OUTCOME
After much research and internal debate, I finally felt
prepared to approach my boss. I decided to respectfully
present my data to Dr. X and show my confusion as to why
the patients were enrolled into the trial. Once again, he
rejected my data and told me to trust his judgement.
However, I kept persisting and I expressed my concern for
the trial. I proposed testing the patients a third time to
confirm their results. I also explained that if we are not
careful in choosing patients, and the patients are indeed not
fit for the study, several consequence could follow. The
FDA could find out and shut down our trial and possibly our
company, leaving us without jobs. Furthermore we would be
putting not only the trial patient’s health at risk, but also the
3
Kate Lundy
(online
news
report).
https://www.asrs.org/retinatimes/details/131/fda-approves-world-first-artificial-retina
[5] M. Siegel. (2011). “On ‘Grey’s Anatomy,’ an Altruistic
Act in Alzheimer’s Study Could Wreak Havoc.” Los Angeles
Times.
(online
article).
http://articles.latimes.com/2011/may/09/health/la-he-unrealgreys-anatomy-20110509
[6] NSPE. (2007). “Code of Ethics for Engineers.” National
Society of Professional Engineers. (online article).
http://www.nspe.org/sites/default/files/resources/pdfs/Ethics/
CodeofEthics/Code-2007-July.pdf
[7] BMES. (2004). “Biomedical Engineering Society Code of
Ethics.” Biomedical Engineering Society. (online article).
http://bmes.org/files/2004%20Approved%20%20Code%20o
f%20Ethics(2).pdf
[8] E. Svoboda. (2014). “The Morality Workout: Exercises to
Be More Ethical.” The Oprah Magazine. (online magazine).
http://www.oprah.com/spirit/How-to-Make-EthicalDecisions-Morality-Workout
also like to thanks Dr. Budny for being an inspirational
engineering professor.
ADDITIONAL SOURCES
E. Butterman. (2014). “Ethics in Engineering.” American
Society of Mechanical Engineers. (online article).
https://www.asme.org/engineeringtopics/articles/engineering-ethics/ethics-in-engineering
M. Crawford. (2012). “Engineers Must Embrace Aspirational
Ethics.” American Society of Mechanical Engineers. (online
article).
https://www.asme.org/engineeringtopics/articles/engineering-ethics/engineers-must-embraceaspirational-ethics
R. Popp. (2009). “Case 13 – Patient Recruitment.” Stanford
Biodesign.
(online
article).
http://biodesign.stanford.edu/bdn/ethicscases/13patientrecrui
tment.jsp
NSPE. (2013). “Public Health and Safety – Delay in
Addressing Fire Code Violations.” National Society of
Professional
Engineers.
(online
article).
http://www.nspe.org/sites/default/files/BER%20Case%20No
%2013-11-FINAL.pdf
Y. Xia., Q. Ren. (2013). “Ethical Considerations for
Volunteer Recruitment of Visual Prosthesis Trials.” Science
&
Engineering
Ethics.
(online
article).
http://web.b.ebscohost.com/ehost/pdfviewer/pdfviewer?sid=
3cd77e71-348a-49b6-b2ef9d1866d918a1%40sessionmgr198&vid=3&hid=118
J. Young. (2008). “It’s All the Same….” webGURU. (online
article). http://www.webguru.neu.edu/professionalism/casestudies/its-all-same
ACKNOWLEDGEMENTS
I would like to thank my writing instructor Nancy Koerbel
and the writing center staff located in the Hilman Library for
helping me in the process of writing this assignment. I would
4
Your Name
5