Budny 4:00
R02
HOW ETHICS APPLIES TO BIOPRINTING TECHNOLOGY
Nicholas Krall (ndk18@pitt.edu)
US SOLDIERS AND BIOPRINTING ETHICS
My team of biomedical engineers and I are in Afghanistan
testing a newly developed portable bioprinter in the Army’s
medical unit. Although this bioprinter has been fully approved
by the Food and Drug Administration (FDA) for human use,
we are only in the unit to see if the printer’s size is small
enough to be quickly transported to any unit that may need it.
A soldier who was in contact with an improvised explosive
device is brought into the unit with a burn on 40% of his body.
This situation is very serious because burns that are on an area
greater than 15-20% of the body often result in the patient
going into shock without immediate treatment [1]. Knowing
this, the medical staff assigned to the soldier decide to avoid
a skin graft due to its lengthy preparation time [2]. One of the
doctors contacts myself telling me the situation and asks if I
would be able to use the printer to synthesize a new skin for
the soldier and potentially save his life.
I know that the bioprinter requires the use of different
hydrogels, or biological material used in the support of human
cells, to act as a support and culture for the human
keratinocytes and fibroblasts to grow and attach to the
subjects burned skin [3] [5]. I ask the doctor which hydrogels
the unit carries, because some are not approved by the FDA
for use on human subjects. He tells me that the only hydrogel
that they have readily available is Extracel™ UV because the
bioprinter was not officially supposed to be in use at that unit
until next year. From my research over the years, I know that
Extracel™ UV was determined to be one of the best hydrogels
due to its fast printing process, its high viability and growth
of cells several weeks after surgery, and its minimal swelling
ratio [1]. Extracel™ UV and many other hydrogels had been
thoroughly tested on animals, but only a few passed the
FDA’s approval for human use [1]. Even though Extracel™
UV hydrogel was found to be the most effective hydrogel in
terms of the factors above, it is not officially approved by the
FDA for human use. If I chose to use the Extracel™ UV
hydrogel on a human subject and there were any
complications that arose, I could be sued for malpractice and
be looked down upon by my engineering peers. On the other
hand, if I decide to not use the bioprinter, the soldier has a
very high chance of passing away. As a biomedical engineer
my final decision will need to be based around the codes of
ethics I have learned throughout my college years, as well as
other credible human ethical sources. These sources include:
the BMES Code of Ethics, the NSPE Code of Ethics, two
sources that outline engineering ethics, and two court cases
that are similar in to my scenario.
University of Pittsburgh, Swanson School of Engineering 1
2013-1029
ENGINEERING CODES OF ETHICS AND
HOW THEY CAN HELP MAKE DECISIONS
The two most important sources to reference for decision
making as a biomedical engineer are the National Society of
Professional Engineers’ (NSPE) Code of Ethics and the
Biomedical Engineering Society’s (BMES) Code of Ethics.
These sources are the most important overall because they
outline how engineers and biomedical engineers should act in
the professional world. Given these two codes of ethics, an
engineer should be able to produce a solid decision for any
problem that arises while working in the field.
In my scenario, the NSPE has one major canon that will aid
in my final decision. The cannon I am referring to states that
“Engineers shall hold paramount the safety, health, and
welfare of the public” [6]. This cannon both supports and
discourages the use of the bioprinter for this scenario. The
cannon supports the use of the bioprinter because it clearly
states that above all other things, the health of the public, or
in this case the soldier, must be maintained. Now as an
engineer, I must consider that if I were to not use bioprinter,
the soldier would have to receive a skin graft to treat the
wound. Forcing the soldier to receive a skin graft with a burn
that covers 40% of his body would be crossing the first
cannon because skin grafts take a long time to prepare which
would put him at a very high risk of going into shock and
dying [2] [3] [5]. Even if I did decide to let the doctors
perform a skin graft and it was successful immediately after
the surgery, there is a risk of one of many complications of a
skin graft occurring sometime after the surgery. These risks
can include but are not limited to, infection, hematoma, loss
of nerve tissue, and loss of functionality of the burned body
part [4]. Since the burn area is so large, the possibility of one
of these risk factors happening is increased greatly [2].
Therefore, if the skin graft was successful, I would still be
breaking the first cannon because I am putting the soldier at
great risk for his health in the future. Continuing on this, a
research study by Thourani et. al. showed that the success rate
of a skin graft on a patient with a burn area of 35% or greater
is very low compared to others [2]. Again, I would be
breaking this first cannon because a failure of the skin graft
would be very detrimental to the soldier’s health and the
increased time to do another skin graft would put him at
higher risk for shock. In summary, not using the bioprinter on
the soldier would be breaking the first code in the NSPE Code
of Ethics because performing a skin graft on him would put
his health at great risk no matter the circumstances. The first
code in the NSPE Code of Ethics discourages the use of
bioprinter much in the same way it supports it. Because the
Nicholas Krall
use of Extracel™ UV has not been tested on humans yet, there
is no way to determine if there are any risk factors for its use
on humans. If I were to use the bioprinter on the soldier and
there was some complication, whether the skin healed or not,
it would be breaking the first code because his health would
be in danger.
In my scenario, I believe my moral virtues are an important
component to what will make my decision. I believe this
because even though there are many ethical factors that
influence the decision, the scenario can be broken down to a
moral question of choosing life or death. I can break down the
scenario this way based on previous research on Extracel™
UV and bioprinting on animals that have a very similar
biological make-up to humans. An example of this research is
the completely successful of bioprinting cells on to mice done
by Binder et. al. and Michael et. al. In both of these cases, the
mice that had skin bioprinted on their burn wounds not only
survived, but grew skin that was extremely similar in structure
to that of a humans epidermis [3] [4]. If I were to apply this
“right of conscience” to the now broken down moral question
of life or death, I would quite obviously chose for the soldier
to live.
The BMES Code of Ethics has two principles that apply to
this scenario. The first principle is that biomedical engineers
must, “Use their knowledge, skills, and abilities to enhance
the safety, health, and welfare of the public” [7]. This is just
a repeat of the NSPEs code of ethics which is to prioritize the
health of the public. The BMESs first code supports and
discourages the use of the bioprinter with the same reasons
that were stated with the NSPEs first code and its application
to the health of the soldier. On the other hand, the BMES Code
of Ethics does have another principal that fully discourages
the use of the bioprinter. This BMES code states that
biomedical engineers have to, “Comply fully with legal,
ethical, institutional, governmental, and other applicable
research guidelines, respecting the rights of and exercising the
responsibilities to colleagues, human and animal subjects, and
the scientific and general public” [7]. This principal
completely discourages the use of the bioprinter because
using the Extracel™ UV hydrogel would be disregarding
FDA regulations. Since Extracel™ UV is not approved by the
FDA for use on humans, it is against FDA regulation to use it
in any circumstance no matter how well it has acted in
previous research. As a biomedical engineer I would be in
direct opposition to the BMES Code of Ethics as well as in
trouble with the FDA for breaking a regulation. In summary,
both the BMES Code of Ethics and NSPE Code of Ethics
offer great insight that will help me in my final decision.
An article written by Jessica Li and Shengli Fu about how to
teach ethical engineering adds to the concern of moral
decisions in engineering. In the article, the Li and Fu say the
two ethical scholars, Martin and Schinzinger, believe there
are two major points to how engineers should be taught to deal
with ethical situations. Martin and Schinzinger believe
engineering ethics, “(1) consists of the responsibilities and
rights of those engaged in engineering, and also their
desirable ideals and personal commitments; and (2) is the
study of the decisions, policies, and values that are morally
desirable in engineering practice and research” [9]. The first
point Martin and Schinzinger state shows that an ethical
decision in engineering should be based on not only codes of
ethics, but also an engineer’s personal ideals and
commitments. I interpreted the second point of Martin and
Schinzinger to be an addition to the first; the study of
engineering ethics should teach an engineer the policies
(codes) of engineering in combination with what values of an
individual are morally desirable in the professional
engineering world. According to these points, I am not able to
make a completely moral decision given just the codes of
ethics for the BMES and NSPE. With the addition of my own
values and ideals, I should be able to make a morally desirable
decision. My personal value for the given scenario is as
follows; if there is a possibility to save the life of a human, the
necessary steps should be taken in order to do so. This makes
me conclude that the morally correct decision for the scenario
is to use the bioprinter to save the life of the soldier no matter
the consequences that follow.
ADDING MORALITY TO
ENGINEERING ETHICS
Because the two codes of engineering ethics do not give a
definite solution to the scenario, I must reference more
sources that offer a different insight to how this issue could
be solved. For instance, in book about ethics and engineering
written by Englehardt et. al., there are multiple sections that
specifically explain how to deal with cases of morality in the
field of bioengineering. Since the scenario is a question of life
or death for the soldier, I believe a moral approach to solve
the problem is the best way to approach it. In Englehardt’s et.
al. book they state that some major ethicists believe, “a ‘right
of conscience’ (a right to refuse to do something that violates
one’s conscience) should be a part of engineering code” [8]. I
agree completely with this statement because both
engineering codes of ethics I referenced cover what an
engineer should do for situations that have one distinct ethical
decision, but lack what an engineer should do when faced
with scenario that entails a decision with personal morality.
SIMILAR COURT CASES AND
CONSEQUENCES
As I have outlined in the previous to paragraphs, an engineer
should not rely solely on the codes ethics to make decisions,
but rather should add their own values and ideals that comply
with the codes of ethics in order to arrive at a morally and
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ethically sound decision. As an engineer with a serious
decision in my hands, I have thought of two more factors that
can aid me in my final decision. The first of the two is an
example of what can happen to citizens of the United States
when they break FDA regulation. The case is about three men
who were in a plot to manufacture, distribute and sell to the
public stem cells and stem cell procedures that were not
approved by the FDA [10]. When the FDA found out about
their scheme, they were promptly arrested and held in court.
The three men were allegedly using the stem cells to help treat
and cure people with otherwise incurable diseases under the
table [10]. Even though they were helping diseased
individuals, they were still arrested due to the fact that they
broke FDA regulation. This can be applied to my situation
because if I were to use the bioprinter and FDA unapproved
hydrogel, I would be arrested whether or not the soldier
survived. This fact alone makes me lean towards telling the
doctors that I cannot use the bioprinter for the soldier. If I
were to use the bioprinter and was held in court by the FDA,
I would have one strong argument which is the second factor
mentioned early. This second factor resides with the
Pennsylvania Consolidated Statutes and could be used as
somewhat of a counter argument as to why the decision to
save the soldiers life was made. In chapter 83 of the statutes
regarding immunities to citizens, there is a reference to how a
trained medical professional can be granted immunity from
the liability of civil damages if the procedure was in good
faith [11]. Trying to use this law would be a stretch mainly
because I am a not a licensed medical professional. I believe
that if I explained that I am trained to use the bioprinter as
biomedical engineer and that I proved that I acted to save the
life of a soldier, that I could escape some of the charges that
would be filed. Taking the possibility of getting charged by
the FDA but having a strong counterargument into
consideration, I believe that deciding to use the bioprinter is
even more viable decision.
codes of both the BMES and NSPE codes that state that above
all a biomedical engineer should uphold the health of the
public.
To further proof that my decision is the one that complies the
most with the code of ethics, there is a sub-rule in the NSPE
Code of Ethics that states, “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” [6]. This code means that
regardless if I had broken FDA regulation, if I report the
scenario to an official, I am still in accordance with the NSPE
Code of Ethics. Even though my decision will cause me to be
in serious trouble with the FDA, I have a strong argument that
shows that I acted in a matter of good faith. Above all my
decision is the one that complies with, what I believe, are the
most humane values. If I were to let the soldier receive a skin
graft I would be acting against my own personal ideals, which
are a large portion of decision making as an engineer
according to the scholar ethicists mentioned earlier. Building
off of this last point, in the book by Englehardt et. al., they say
to make an ethical decision, engineers should act with “those
actions or practices that protect and respect the moral agency
of human beings” [8]. Quite evidently, if I were to let the
doctors perform a skin graft which was likely to result in
death, I would not be choosing a decision that respected the
moral agency of human beings. I made this decision not only
acting as an engineer, but as a fellow human being. If I were
the soldier in the same situation, I would certainly want
anyone to take every measure to improve my chance for
survival. My decision to use the bioprinter on the soldier was
the right decision because it follows the most engineering
codes of ethics while still being the most morally correct
decision.
REFERENCES
FINAL DECISION AND HOW I CAME
TO IT
[1] Murphy SV, Skardal A, Atala A. 31 August, 2013.
Evaluation of hydrogels for bio-printing applications. J
Biomed Mater Res Part A 2013:101A:272–284. Web. 26 Sept
2013.
[2] Thourani, VH, WL Ingram, and DV Feliciano. "Factors
Affecting Success of Split-thickness Skin Grafts in the
Modern Burn Unit." 01 October, 2013. National Center for
Biotechnology Information. U.S. National Library of
Medicine, Mar. 2010.
http://www.ncbi.nlm.nih.gov/pubmed/12634539
[3] Binder, Kyle W., Weixin Zhao, Gil Young Park, Tao Xu,
Dennis Dice, Anthony Atala, and James J. Yoo. May 2011. In
Situ Bioprinting of the Skin for Burns. Ccc.amed.army.mil.
Wake Forest Institute for Regenerative Medicine, Imperial
College London, Web. 27 Sept 2013.
https://ccc.amedd.army.mil/conferences/2009/posters/RM9.p
df.
My final decision as a biomedical engineer would have to be
in the side that followed the most codes of engineering ethics
while keeping in mind the moral obligations of a human being
and engineer. Both decisions break at least one of either the
NSPE Code of Ethics or the BMES Code of Ethics. My
research of engineering ethics shows that a decision should be
a combination of these codes as well as self-values that are
desirable in professional engineering. The desirable values
are those values that align with humane morality; those that
treat others with respect and dignity. My final decision as a
biomedical engineer is to use the bioprinter and FDA
unapproved Extracel™ UV hydrogel to attempt to save the
soldiers life. This decision does not follow the first
biomedical research obligation of complying fully with
governmental research guidelines, but it does uphold to major
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Nicholas Krall
[4] Michael, Stefanie, Heiko Sorg, Claas-Tido Peck, Lothar
Koch, Andrea Deiwick, Boris Chichkov, Peter M. Vogt, and
Kerstin Reimers. "Tissue Engineered Skin Substitutes
Created by Laser-Assisted Bioprinting Form Skin-Like
Structures in the Dorsal Skin Fold Chamber in
Mice." National Center for Biotechnology Information. U.S.
National Library of Medicine, 03 Apr. 2013. Web. 01 Oct.
2013.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3587634/.
[5] Binder, Kyle W., Weixin Zhao, Gil Young Park, Tao Xu,
Dennis Dice, Anthony Atala, and James J. Yoo. 25 Sept.
2013. In Situ Bioprinting of the Skin for Burns.
ScienceDirect. Wake Forest Institute for Regenerative
Medicine, September 2011. Web.
http://www.sciencedirect.com/science/article/pii/S10727515
10006307#.
[6] "NSPE Code of Ethics for Engineers." NSPE Code of
Ethics for Engineers. N.p., July 2007. Web. 25 Oct. 2013.
http://www.nspe.org/Ethics/CodeofEthics/index.html.
[7]
"Biomedical
Engineering Society Code
of
Ethics." Bmes.org. N.p., Feb. 2004. Web. 25 Oct. 2013.
http://bmes.org/files/2004%20Approved%20%20Code%20o
f%20Ethics(2).pdf.
[8] Harris, Charles E., Michael S. Pritchard, Michael J.
Rabins, Ray James, and Elaine Englehardt. 25 Oct. 2013.
"Engineering Ethics: Concepts and Cases." Google Books.
N.p., Jan. 2013. Web.
http://books.google.com/books?hl=en&lr=&id=B3sqYcyVDkC&oi=fnd&pg=PP1&dq=Ethics+in+engineering&ots=6z
XfB7t3vC&sig=zxGZgtNklReI-MhuhCYhbyyn8g#v=onepage&q&f=false
[9] Li, Jessica, and Shengli Fu. 25 Oct 2013 "A Systematic
Approach to Engineering Ethics Education." N.p., 23 Nov.
2010. Web.
http://link.springer.com/article/10.1007/s11948-010-92498/fulltext.html
[10] Food and Drug Administration. US Department of
Justice Press Release. N.p.: n.p., n.d. Federal Indictments
Lead to Arrests in Stem Cell Case. 28 Dec. 2011. Web.
http://www.fda.gov/ICECI/CriminalInvestigations/ucm2859
81.htm.
[11] PA Good Samaritan Law (Statute). N.p., n.d. Web.
<http://www.concentric.net/~Maxfax/files/law2.htm>.
Dr. Ronald Krall MD (uncle), also a Pitt Medical School
graduate
Mary Beth Krall (mother) nurse for many years at UPMC
Presby
Jenna Krall (sister) PhD candidate for biostat at Johns
Hopkins University
ACKNOWLEDGEMENTS
I would like to personally thank the following people because
they have shared their knowledge of medical burns and how
to write a good research paper. Due to their expertise, I was
able to write a most of this paper on knowledge I have gained
from them. Also, they each gave an answer to what they
would do if they were put in the same scenario
Dr. Sherwood Chetlin MD (uncle), Pitt Medical School
Graduate
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Nicholas Krall
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Nicholas Krall
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FIGURE 1 [3]
Mars Rover Curiosity’s tool turret and flexible arm
Figures: Pictures, Drawings, Graphs, Tables, etc.
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For example
Note: all figures must have a FIGURE number, a
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The drill used to collect rock samples on Mars is located on
the “tool turret” at the end of Curiosity’s robotic arm, as
shown in Figure 1. In May of 2013, the drill bored into a
specifically targeted area of Mars rock and obtained a
powdered sample of the rock [4].
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[2] S.D. Brown, P. Nativo, J.A. Smith, et al. (2010). Gold
nanoparticles for the improved anticancer drug delivery of the
active component of oxaliplatin.” Journal of the American
Chemical Society. (Online article). DOI: 10.1021/ja908117a.
pp. 4678–4684
[3] D. Chandler. (2012). “A New Dimension for Solar
Energy.”
MIT
News.
(Online
article).
http://web.mit.edu/newsoffice/2012/three-dimensional-solarenergy-0327.html
[4] “Carbon Fiber Concrete Arch Bridges.” (2012). University
of Maine Advanced Structures &Composites Center. (Video).
http://www.youtube.com/watch?v=bupAxrq1_Iw
[5] D. Budny, K. Bursic, N.Vidic, et al. (2011). “Freshmen
are the Best Inventors.” Journal of Engineering Education.
(Print article). Vol. 99, no 3. pp.78-80
[6] E. Strickland. (2012, Sept 5). “Wireless Power Beamed
Straight to Your Heart.” IEEE Spectrum Tech Talk. (Online
blog). http://spectrum.ieee.org/blog/tech-talk
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In this section you thank anyone who has provided
substantial inspiration and support through your process of
writing. For example, you might thank your 0011 instructor,
and/or the Bevier Librarians, and/or a Writing Center tutor,
You might thank a mentor, friend, or roommate with whom
you had useful discussions about the paper.
REFERENCES
[1] G. Kalonji. (2008). “Preface.” UNESCO Report,
Engineering: Issues, Challenges, and Opportunities for
Development.
(Online
Report).
http://unesdoc.unesco.org/images/0018/001897/189753e.pdf
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