Mahboobin 10:00
R01
ETHICS OF FIBROIN
Jeremy Pedersen (jrp104@pitt.edu)
PRESENTING THE FACTS
The business I work for, Aevum Solutions, is a
newly formed company that works in the research,
development, and production of biomaterials. An outside
investment firm is willing to pay for the production and
distribution of our newest biomaterial, fibroin, if we move it
to the market within the next month. The firm most likely, as
an investment firm, sees only the monetary side of the
material, fibroin, but fibroin has many useful applications to
the advancement of human health.
Fibroin is a biomaterial originating from the silk
spun by lepidopterans, an order of larvae. After
manipulation in the lab by processes such as super heating,
snap freezing, Ph baths, and polar distortions, fibroin can be
used as a cell base in the eyes. Cell bases are non-living
materials which serve as foundations for cell growth. A
majority of cells will not naturally integrate into an organism
and remain at the location of transplantation without the
assistance of a cell base. At the moment, fibroin is the only
durable and bio-compatible biomaterial. Fibroin has several
outstanding qualities, such as its ability to act as a
semipermeable membrane and to maintain a transparent
quality after implantation.
Fibroin’s varied qualities give it great potential for
use in the medical field. Thousands of people who need
implants could be saved by the release of this biomaterial.
Fibroin is a cheaper alternative to implants, giving access to
health care for the less fortunate. Fibroin is also more
accessible than eyes for transplanting. Most third world
countries don’t have the cold storage needed to store organs,
but they could store fibroin.
The investment firm sees the wide market for our
biomaterials use. Still, other companies are also working to
produce a functional biomaterial cell base. If Aevum
Solutions works with the firm, we have the chance to be the
first biomaterial producer on the market. The first product to
make the market will make the most profit, which is where
the push to release soon originates. Without the help from
the firm, our company may not have the ability to release
fibroin and distribute it into the medical world.
THE ETHICAL DILEMMA
I work as an ocular bioengineer for Aevum
Solutions and I am currently researching the use of fibroin
for regeneration of ocular tissues and prevention of
degenerative ocular disease. My work has only taken place
for slightly over two years. Animal testing stages started
only eight months ago. What I have seen in the tests so far is
extremely promising, and I have reported so. Yet,
with release in only a month, I have not determined if the
fibroin will stay a translucent substance after an extended
period of time, nor have I determined what effects there will
be on humans after a long period of time. Long term effects
on humans could range anywhere from minor eye pains to a
cancerous growth. Cancer could develop if the cell base
degrades and allows for cell growth in the opposite direction
of its implantation. Both of these are possible implications
that could harm human well-being, defeating the goal and
purpose of its production.
Aevum Solutions still wishes to proceed with
pushing fibroin to the market despite a lack of research and a
possible endangerment to humans. They have asked me to
sign off on a form giving my consent for fibroin’s
production. By giving my consent, I would be stating that
fibroin is acceptable for use in the medical field. If I sign off,
our company will receive necessary financial assistance to
get fibroin off the ground, possible world recognition, and a
large profit. For me, I would likely receive a promotion and
recognition as an engineer.
ETHICAL QUESTIONS AND CODES
To decide what action should be taken in regards to
signing the form for fibroin’s production, the codes and
cannons of ethics for engineers and biomedical engineers
must both be taken into consideration. The cannons that are
most applicable to this specific case are the NSPE’s cannon
1, 2, 4, and 6. Respectively, that an engineer will “hold
paramount the safety, health, and welfare of the public” to,
“perform services only in areas of their competence” to,
“Act for each employer or client as faithful agents or
trustees”, and “Conduct themselves honorably, responsibly,
ethically, and lawfully so as to enhance the honor,
reputation, and usefulness of the profession” [1]. The other
two cannons, concerning deceptive acts and answering only
in objective matters, are of less concern because I am not
trying to hide any of the truth. The other rules that should be
considered include the NSPE’s code 3.2, 3.6 and all of the
biomedical engineering code of ethics because all of it
applies.
Other than the codes of ethics, previous ethical papers
and situations with similarities to my situation can help me
make a decision. Also the input from outside sources that
influence my personal moral system should be referenced.
THE CODES DISCUSSION
The first cannon of the NSPE’s code of ethics is about
the safety of the public, and so is the BMES’s first code. The
University of Pittsburgh, Swanson School of Engineering 1
2014-10-28
Jeremy Pedersen
only difference is that the BMES code is to the “enhance the
safety, health, and welfare” [2] as opposed to the NSPE,
which is to simply “hold” [1] the safety. The two rules are
very similar in wording, but in practice can conflict. In the
case of fibroin, its use has the potential to fulfill both codes,
and yet possibly neither. Fibroin can, and will, in the short
run, help people who have ocular disabilities. There is very
little risk involved in the placement of fibroin as it is hardly
rejected by the body unlike full ocular transplants. This
means the health of the public is being held. Fibroin also can
improve the eyesight of people whose eyes are losing their
natural abilities. This means that fibroin also can enhance
the well-being of the public. Where it can fail both codes is
in the future. If, in ten years the fibroin degrades and allows
the cancerous spread of cells, the health of the public will be
in jeopardy, breaking the NSPE code. Also if the fibroin
loses its translucence, then the recipient’s eyesight will lose
clarity, which is a denigration, which breaks the BMES
code. So the question raised for me to answer is if the
immediate health and enhancement of the general public is
important enough to out weight the risk of a troublesome
future.
To aid me in my decision for this dilemma, of the present
versus the future, is the second code in the NSPE ethics. The
second code states that I can only act based on “areas of my
competence” [1]. The longevity of fibroin is not within my
engineering parameters. My job was to only create the
product. The job of the quality engineer is to do the stress
tests of the fibroin. There simply has not been enough time
for that engineer to perform the given task. According to
NSPE code 3.7, when I “believe others are guilty of
unethical or illegal practices” that I shall “present such
information” to the “proper authorities” [1]. According to
the same rule though, I am not entitled to review another
engineer’s work unless they are from another supplier.
Unless I find the quality engineer’s work obviously
unethical, I have no incentive to report save, that I have a
reasonable doubt in the ability to hold the public’s safety.
This code, 3.7, tells me that if that if fibroin does fail in ten
years, then the blame will not fall on me. It may however be
my duty to warn my superiors that one of my co-workers has
not properly done his job. Whether or not he actually has is
not up to me to decide and I am not required to investigate
so it is likely that I would let the quality engineer pass. This
code helps me lean towards the side of releasing the fibroin
as it is not required that I account for the future.
The next code to help my decision is the NSPE’s code
2.4.1 and 2.4.3. Both are under the code which states that
“Engineers shall act for each employer or client as faithful
agents or trustees” [1]. Part one states that engineers must
disclose “all known or potential conflicts” that may
“influence their judgment or the quality of services” [1].
Because the long-term effects of fibroin are unknown they
are a potential conflict of our services which must be
reported. Part two states that engineers shall “not accept
financial or other valuable consideration directly or
indirectly from outside agents in connection with the work
for which they are responsible for” [1]. This code of ethics
only applies assuming I am rewarded financially for the
release of the product, which is likely. I may not be paid
directly by the investment firm, but a raise is likely from my
company, which would be an indirect result of the release of
fibroin. This financial compensation on its own makes
allowing an outside firm to pay for the release of our product
unethical. Codes, 2.4.1 and 2.4.3, push me towards not
releasing fibroin.
In relation to money, the BMES code of ethics states that
engineers will “Consider the larger consequences of their
work in regard to cost, availability, and delivery of health
care” [2]. If our company is to receive monetary gain from
the release of fibroin, we will have more capitol for further
research. Further research could lead to improvements to
fibroin or even the production of a superior biomaterial.
Allowing for the release of under developed fibroin may
lead to the harm of a few, but could allow for the saving of
many in the future. It is also possible that those few will not
actually be harmed. From this code, I find that releasing
fibroin is ethical, as it may help the overall future health and
public well-being.
APPLICATIONS OF ARTICLES
Books have been written on how to act when confronted
with an ethical dilemma. An entire book on how to act
during an ethical dilemma for biomedical engineering
specifically, has also been written. This book, Biomedical
Ethics for Engineers, is a worthwhile source to look at as it
has been published, reviewed, and accepted by the general
engineering society. The examples found within are a good
instance for which I should I act in comparison to. Stated in
the book is that human improvement and “enhancement is an
optimization between risk and opportunity” [3]. In my case
the risks are the health of the public, but the opportunity is
greater human health in the long run, increased wealth, and
increased scientific knowledge. The weight of the risks and
opportunity is for me to decide in this case. Following this
advice I would likely lean on the side of releasing fibroin
because the possible benefits far outweigh the risks.
Another statement within the book is that “voluntary
consent of the human subject is absolutely essential” [3].
According to this statement, it would be completely
unethical to allow the first set of people using fibroin to be
the test for its effectiveness. Unless they consented. So a
possible work around would be to explain the risk to the
patient and only proceed if and only if they understand and
accept the risks associated with fibroin. By this method, the
cost of human health is a little more ethical as the human
subject understands the situation and is willingly involving
themselves. Resulting from this example, I would once more
lean towards the release of fibroin, but this time only when
subjects are informed of its risks.
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Jeremy Pedersen
A small article titled, Communitarian Bioethics: Three
Case Studies, goes into detail on whether or not it is ethical
to take a save the masses over the individuals approach. This
applies directly to my case because one of my main points is
that a sacrifice in the small amount of people using fibroin at
the start could help save many in the long run. According to
the article there are, “conditions under which individuals
have to accept various sacrifices for the good of all” [4]. If
this is true, then I should indeed press forward with the
release of fibroin; however, I must still take into account that
it is only true under certain conditions. Later in the article it
is stated that there must be “patient rights” that include
“debriefing” [4] for any tests or treatments. From this I lean
towards the idea that the release and use of fibroin would
once more be ethical if and only if the subjects were told of
the risks. Once informed of the risks it is ethical to believe
that it is worthwhile to put the few at risk in order to save the
majority.
MY MORAL GUIDANCE
Many of the factors that weigh into my decision involve
my own moral beliefs. Much of my moral system has been
molded by the society that I live in. The best examples of
that society are the people that I surround myself with,
specifically my peer group and my parents. Due to these
groups impact on me, I have talked over this ethical dilemma
with both groups.
My parents are not only a good representation of my
morals, but they are also two people who I often look to for
guidance. My mother told me that it would be unethical to
release a product that is not finished, stating that it would be
a breach of the public’s trust in a quality product [5]. This
statement assumes that fibroin is not up to a standard quality,
which it is, but I do take into account that she is right that it
would be unethical to breach the trust of the public. My
father on the other hand, simply stated that if it would help
more than it could harm, then it should be released [5]. From
my mother I once more lean towards the idea that fibroin
should be released, but with a warning or caution statement.
From my father, I think releasing it would help more than it
would harm, which would mean I should allow the fibroin to
be medically used.
My peers also have a large impact on what I find to be
ethical or unethical and they also are a representation of my
generation and what they believe. A majority of my peers
stated that it would be unethical to allow any people at all to
come in harm’s way simply for a chance at a better future
[6]. According to them, all lives should be seen as equal
opportunity and risking one is just as unethical as risking a
possible five. From my friends I lean towards the side of not
releasing the fibroin and to continue working on it in the lab
at the risk of not ever being able to produce it and losing
some recognition as an engineer.
DECISION AND RECCOMENDATION
After reviewing the many ethical rights and wrongs of
releasing fibroin with the help of an investment firm while
not having full research, I have concluded that I would
release the biomaterial. Due to the dangers involved I would
only do so on the condition that any patients to receive
fibroin first understand and accept the possible long term
effects.
To come to this conclusion I took into account the
materials reviewed from the codes of ethics, the articles, and
from my parents and peers. According to the codes of ethics,
both the BMES and NSPE code, I am not held accountable
for the degradation of fibroin as testing its long term affects
does not fall under my abilities. The health of the public
will actually be improved upon the release of fibroin, so that
makes it unethical to withhold it. The financial acceptance is
immoral on its own, but will help total public health so once
more, the ethical outweighs the unethical. From the
engineering articles it can be seen that in general, if
something helps a patient but with possible side effects, it is
only ethical if they understand the effects, leading to my
belief that fibroin must have patient understanding. From my
peers I understand that fibroin may cause an unfair loss
initially, but the possible benefits of future progress in the
health field is too great to pass.
To all engineers I recommend going through the same
process for any ethical dilemma. Going through all of the
cannons and rules for the general NSPE and specific
engineering codes will lay down a guideline to base a
decision off of. Looking into other examples can also help
guide to what others would believe to find an acceptable
choice. Finally looking at others with a moral judgment that
one personally looks to can help one understand what they
believe to be the ethical decision.
RFERENCES
[1]"NSPE Code of Ethics for Engineers." National Society of
Professional Engineers.
[2] "Biomedical Engineering Society Code of Ethics."
Biomedical Engineering. Worcester Polytechnic Institute
[3] D. Vallero. (2007) Biomedical Ethics for Engineers
Ethics and Decision Making in Biomedical and Biosystem
Engineering. Amsterdam: Elsevier/Academic. (print book)
[4] M. Gross. (2014) Communitarian Bioethics: Three Case
Studies. New York: Springer Science+Business Media (print
article)
[5] R. Pedersen, S. Pedersen. (2014, October 25). Interview
[6] C. Bogart, M. Farrell, C. Pinkerton, V. Stevans. (2014,
October 20) Interview.
[7] C.Beck, J. Branch, D. O’Brien, L. Patterson, R. Andreoli,
M. Usmen, S. Sudler (2013) “Public Health and Safety3
Jeremy Pedersen
Delay in Adressing Fire Code Violations” National Society
of Professional Engineers.
http://www.nspe.org/sites/default/files/BER%20Case%20No
%2013-11-FINAL.pdf
[8] “To Realease, or Not to Release: An Engineer’s
Perspective” Stanford Bio design
http://biodesign.stanford.edu/bdn/ethicscases/21releasequesti
on.jsp
[9] J.R Young (2008) “It’s All the Same…” Chronicle of
Higher
Education.
(Online
journal).
http://www.webguru.neu.edu/professionalism/casestudies/its-all-same
ACKNOWLEDGEMENTS
I would like to acknowledge Caitrin, Coleman, Margaret,
Sean, and Victoria for listening and providing feedback to
my ideas about fibroin and ocular regeneration. In addition
for unconditional support provided. Special thanks to Caitrin
Victoria for editing the paper. Also thanks to my parents for
their moral inputs.
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