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R21
ETHICS IN BRAIN COMPUTER INTERFACE RESEARCH
Samik Patel (sdp34@pitt.edu)
INTRODUCTION
Currently I am a biomedical engineering professor at the
Georgia Institute of Technology. Having obtained a PhD in
neural engineering from the University of Pittsburgh and
also having worked in the industry, I understand the scope of
research and its applications as a biomedical engineer. I
have been a professor at Georgia Tech for roughly two
years, but recently I have been able to begin and direct my
own lab, which focuses on neural engineering, specifically
the applications of brain computer interface technology.
Brain computer interface utilizes involuntary neural activity
of the nervous system to form a communication pathway,
and according to Dr. Anirudh Vallabhaneni, from the
University of Illinois, “signals are initially received to the
computer interface system from the brain through
electroencephalography (EEG), which measures the voltage
in the brain by calculating the ion flow that occurs within
neurons” [1]. After EEG signals are detected, these signals
undergo “feature translation, which provides functions that
correlate to certain movements” [1]. Brain computer
interface technology can have a deep-rooted impact on the
field of neural prosthetics because this technology allows for
the movement of prosthetic extremities at particular joints
through neural impulses.
Scenario
Currently in my lab here at Georgia Tech, we are
working on two rather large projects using brain computer
interface technology. One project is a device for patients
with paralysis due to spinal cord injury and debilitation; this
device uses brain computer interface technology to bypass
areas of the spinal cord that are damaged. As a result, the
patient can transmit neural signals through their spinal cord.
Another project that we are working on is a prosthetic leg
that utilizes brain computer interface technology to create
prosthetic movement to enable performance without much
hindrance in normal activities such as walking. This project
is very similar to the brain computer interface arm being
developed at the University of Pittsburgh; according to Dr.
Jerry Shih, the brain computer interface arm “can correlate
neural signals to prosthetic arm movements at the elbow,
wrist, and finger joints” [2]. Since we have allocated nearly
all of our time into these projects over the last two years, my
lab has very little published in scientific journals.
Our project on the brain computer interface prosthetic leg is
in its final stages of research where we have attached the
neural prosthetic leg to a leg amputee to determine whether
proper movement occurs. This project has taken nearly two
years of development and in these final stages we are
University of Pittsburgh Swanson School of Engineering 1
2014-10-28
extensively determining the proper function of the prosthetic
leg. As a result, we believe this extensive evaluation of the
leg amputee will take nearly six months in order to develop a
relatively long term understanding of whether or not the
neural prosthetic functions correctly.
Currently the Georgia Tech Research Institute is funding
my project; their funds are allocated from alumni donations,
research allocation, and company donations. I have a very
small sum of outside money coming in from Neurosky, a
brain computer interface startup who would like to utilize
my research into creating products that can be developed on
the market. In the last week, I have received notification
from the chair of the biomedical engineering department
here at Georgia Tech notifying me that my funds currently
from the Georgia Tech Research Institute would be severely
diminished in the next two months unless one of my projects
is published. Currently, my lab is furthest along in the
project pertaining to the brain computer interface leg;
however as mentioned earlier, it is still nearly half a year
from being completed in its final stages. A dilemma has
arisen where pressure from my superiors to have
publications could lead to the fabrication of data pertaining
to the actual trial on the leg amputee. If I do not fabricate my
data and submit my results for publication at the anticipated
six month time frame, I will most definitely lose significant
chunks of funding and my lab here would lose much of the
traction it has within the biomedical engineering department
here at Georgia Tech.
If I were to fabricate data, I would complete the twomonth research period set forth, and then fabricate data for
the last four months of the project. Even though this is an
extremely long amount of time, I will show similar
correlation with my data in terms of the range of movement
of the neural prosthetic.
Specifics of Amputee Trial
As mentioned earlier, in this final trial my lab is
attempting to determine the range of motion in a neural
prosthetic for a leg amputee. With the current prosthetic
legs on the market, Dr. Richard Vlek, from Radboud
University, believes there is little “flexibility with ligaments
at the knee, such as the patellar tendon and anterior cruciate
ligament” [3]. In addition there is also little flexibility at the
true ankle joint and the subtalar joint as well [3]. In this
trial, we have attached a neural prosthetic at the lower femur
of an amputee and are determining range of motion over a
six month span of time. The neural prosthetic allows for
motion at the knee and ankle joints. In addition we are
determining the resultant pressure on the hips to determine
whether the neural prosthetic is actually taking pressure off
Samik Patel
of the upper femur by absorbing the pressure at the knee and
ankle. My lab decided on a six month span of time because
in similar research studies on pressure post injury, a six
month time span has been shown to provide the best data
based on leg usage [3].
National Society of Professional Engineers
According to the NSPE Code of Ethics, as an engineer I
am expected “to exhibit the highest standards of honesty and
integrity” [6] so that I ensure the protection of public health,
welfare, and safety. The NSPE Code of Ethics also states
“engineers should be objective and truthful in professional
reports or statements” [6] as noted in Section Three of the
Rules of Practice. In my current predicament, if I were to
publish my results I would not be completely truthful since
much of my data on the final trial involving the leg amputee
would have been fabricated. The NSPE Code of Ethics also
states that all “known conflicts of interest must be stated”
[6]; if I were to reveal my current conflict of interest of
obtaining funding for my lab, I would be subject to extreme
scrutiny in the field of biomedical engineering and Georgia
Tech would also be subject to research violations for
imposing pressure for publications. In addition, the NSPE
Code of Ethics also states that “engineers shall at all times
strive to serve the public interest” [6]. If my fabricated
results were to be published, I would deceive the public into
thinking that my data performs a certain way that shows the
full range of motion when there possibly could have arisen
an issue where malfunction occurred in the range of motion
later in the trial period. As a professional engineer, it is vital
that I abide by the NSPE Code of Ethics in order to ensure
the greater wellbeing of the public.
ETHICS PERTAINING TO BRAIN
COMPUTER INTERFACE AND DATA
FABRICATION
In the field of brain computer interface there are certain
ethical guidelines and principles that have been set forth
previously in other research. It is from this research and
development in the industry, that there are certain implied
ethical standards that must be followed.
Brain Computer Interface
With brain computer interface, a significant current
problem that is occurring, according to Dr. Walter Glannon,
is the “difference that there is between treatment and
research interests” [4]. As an engineer performing research
on the alteration of a neural system of a patient, it is
necessary that I place the patient’s health above the outcome
of the research. There is a constant “pressure to be
published that greatly influences the outcome of the research
being developed and tested” [4]. This pressure as mentioned
by Walter Glannon is important in my scenario because
throughout my research, I must make sure that my patient
has the best possible health, regardless of whether I choose
to fabricate the data or continue the study as anticipated.
Biomedical Engineering Society Code of Ethics
The Biomedical Engineering Society Code of Ethics
(BMES) “reflects voluntary standards of professional and
personal practice for biomedical engineers” [7]. According
to the BMES Code of Ethics, my research must be “free
from inappropriate influence from special interest” [7]; as a
result, in order to abide by the code, the possibility of losing
funds down the road should not influence the integrity of my
research. Also, the BMES Code of Ethics states that I must
“consider the larger consequences of my work in regard to
the patient” [7]. If I were to fabricate my data, I would not
be regarding the patient because another researcher may
build off of my research assuming proper function of the
neural prosthetic leg. If in fact, there were a problem, the
patient could experience issues with his or her neural
prosthetic simply because my data had been fabricated for
my conflict of interest. In addition, the current leg amputee
who the trial is being conducted on would be at a slightly
higher risk of injury since he would get a misrepresentation
of the actual data pertaining to the neural prosthetic leg and
its functionality. Following the BMES Code of Ethics is
vital because it has a greater influence on the welfare of the
patient and his or her safety in research.
Data Fabrication
As noted by Danielle Fanelli maintaining ethical
integrity is vital since “the integrity of research depends on
the integrity of the data and data record” [5]. “Fabrication is
the practice of inventing data, and is the most serious offense
in scientific research, as it challenges the credibility of
everyone” [5]. This is important to note because by
fabricating my data, I would commit a crime that could lead
to an daunting punishment. However it is also noted that the
data fabrication is “hard to prove since the accused scientists
could have claimed to have made an innocent mistake” [5].
If I were to fabricate my data at the current trend of
progression of movement for the neural prosthetic, the
results would be hard to find incongruities in.
ETHICAL STANDARDS
As a professional biomedical engineer who conducts
research, I must follow the National Society of Professional
Engineers (NSPE) Code of Ethics For Engineers and also the
Biomedical Engineering Code of Ethics.
CASE STUDIES
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Samik Patel
Case studies are a valuable way of connecting the current
situation with previous cases that are similar in the fields of
brain computer interface, engineering, and the medicine.
mechanisms and signal transduction within human cells [9].
As a result Dr. Uzelmeier was dropped from the graduate
program at Michigan State, and she was also not allowed to
work for the government for the next ten years [9]. In
addition, Dr. Uzelmeier was prohibited from joining a U.S.
Public Health and Safety advisory committee, board, or peer
review committee [9]. From this case study, it is easily
determined that Dr. Uzelmeier’s work throughout her career
had nearly become invalidated as a direct result of data
fabrication. This is important when comparing it to my
current scenario because the fabrication of data could impact
my status and validity as a researcher and engineer for many
years down the road. When making this decision, the idea of
risking nearly everything that has taken so long to work for
needs to be accounted.
Neurofeedback Acceleration for “Ben”
In this case study, a patient named “Ben” has had a
stroke that has resulted in the paralysis of his arm [3]. He
has regained certain functions within his arm but “Ben” is
now participating in a study that could accelerate his
recovery [3]. The main ethical issue within this case study
lies in the fact that “Ben” could possibly put his health at
risk by participating in a study that accelerates results in
order to obtain data faster. In both this case study and my
dilemma, there exists a possible hindrance with the amount
of time necessary for the brain computer interface procedure
recovery to occur and data to be collected. This case study
also mentions how “no other research exists on the topic of
brain computer interface intervention” [3]; in my current
dilemma, this statement is important because the fabrication
of data will have little support within the field of brain
computer interface and as a result most of my data, if
fabricated would have no absolute justification. The case
study involving the neurofeedback of “Ben” is important to
my study because it can help determine the affects of clinical
brain computer interface research when given a limited
period of time.
PERSONAL SOURCES
From my experiences as an engineer, I have developed a
better understanding on the current ethical issue at hand.
Beyond just case studies, the code of ethics, and other
ethical dilemmas, I have had experiences that have
influenced how I will approach this ethical decision.
Previous Research
As an undergraduate researcher at the University of
Pittsburgh, I had to follow a strict rule of guidelines on data
validity as a member of Dr. Richard Debski’s Orthopedic
Robotic Laboratory. When completing my first project on
distal phalanges arthritis, Dr. Debski made sure that I
followed all of the protocol pertaining to validity. He
believed that if my data were not to have been valid, my
skills and ability as a researcher would have been deemed as
worthless and that I would have been denounced from the
lab [10]. This is important to my current ethical dilemma,
because as a researcher I would hold very little credibility in
the future within the field of brain computer interface not
just at Georgia Tech, but throughout the entire medical
research community.
Dr. John Darsee Data Fabrication
According to Matthew Prichard, Dr. John Darsee was
regarded as a brilliant student and medical researcher at the
University of Notre Dame, Emory University, and Harvard
University in the 1980s [8]. Dr. Darsee’s career as a
researcher was at risk when he was caught fabricating data
for a two-month trial in a matter of seconds. Dr. Darsee was
demoted as a result and his research at Harvard was
followed extremely closely [8]. However it was during this
time that Dr. Darsee maintained his habits of fabricating data
by producing results that seemed “too good to be true” [8].
As a result, Dr. Darsee lost his job and the hospital that he
worked for was forced to pay the $180,000 that the National
Institutes of Health had initially given as a research grant.
This relates to the scenario I am currently in because I run
the risk of possibly losing my job with data fabrication. In
addition, if my results were to be published because of my
data fabrication, Georgia Tech could possibly be at risk of
penalties for my fabrications as well. This case study relates
well to my case at hand because the fabrication of data can
possibly lead to large, imposing penalties.
Parental Advice
When I began my first research project in high school,
my mother, a microbiologist, would always preach the value
of data validity. Being a scientist, my mother understood
how easy fabricating data was and would tell me that “your
data may be complex or simple but configuring your data is
extremely easy” [11]. However, my mother always tells me
the story of her coworker who lost her job for configuring
certain data that was presented to the Food and Drug
Administration. This is important to my current research
because even though I could “configure” my data, I would
be risking nearly everything that I had worked hard for to get
to this point.
Dr. Uzelmeier Data Fabrication
According to Sanaa Al-Makouzi, Dr. Uzelmeier, a
doctoral student at Michigan State University, falsified and
fabricated data in her thesis pertaining to molecular
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Samik Patel
http://eprints.eemcs.utwente.nl/21870/01/Vlek_Nijboer_201
2.pdf. pp. 94-97
[4] Glannon W (2014) “Ethical Issues With Brain Computer
Interface” . Systems of Neuroscience (online article).
http://www.plosone.org/article/info%3Adoi%2F10.1371%2
Fjournal.pone.0005738
[5] Fanelli D (2009) “How Many Scientists Falsify and
Fabricate Research? A Systematic Review and MetaAnalysis of Survey Data” . Plus One (online article).
http://www.plosone.org/article/info%3Adoi%2F10.1371%2
Fjournal.pone.0005738
[6] “NSPE Code of Ethics For Engineers” . National Society
of Professional Engineers (online webpage).
http://www.nspe.org/resources/ethics/code-ethics
[7] (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] Pritchard M (2011) “Case Study 1: Overly Ambitious
Researchers Fabricating Data” Online Ethics Center (online
article) http://www.onlineethics.org/cms/9728.aspx
[9] Al-Marzouki S, Evans S, Marshall T (2005) “Are these
data real? Statistical methods for the detection of data
fabrication in clinical trials”. BMJ (online article)
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1181267/
[10] Debski R, (2014, Sep 29). Conversation
[11] Patel V, (2013, June 13). Conversation
CONCLUSIONS
Ethical Decision
The pressure from Georgia Tech to publish my research
has led to the dilemma of either fabricating my data or
completing my research with the risk of possibly losing
funding for research projects in the future. I believe that
through the Engineering Codes of Ethics and through
previous case studies, it would be best for me to complete
the research at the six-month time frame as initially
proposed. This is important because the field of brain
computer interface is relatively young, with very little
research, and as a result my research on neural prosthetic
legs will have greater weight in the brain computer interface
field.
As a researcher, I must have no conflicts of interest that
affect the outcome of the possible research. The risk of the
Georgia Tech Research Institute cutting funding is extremely
likely, however it is possible to find outside funding and also
to repossess funding from Georgia Tech sometime in the
future. In the best interest of the field of brain computer
interface, the amputee patient, and myself, it is necessary
that I do not subject myself to the pressures of Georgia Tech
funding to fabricate data in my research pertaining to motion
of a neural prosthetic leg.
Recommendations to Engineers
ACKNOWLEDGEMENTS
From this paper, I have considered the ethics behind
conducting valid research and fabricating data. In analyzing
my ethical dilemma, I looked at the code of ethics, previous
research, cases studies, and my personal experience. I
believe that looking at each of these phases helps to make a
much better ethical decision. The advice that I would give
to an engineer in a similar scenario or ethical dilemma
would be to separate the conflicts of interest from the
research at hand. When faced with an ethical dilemma,
personal conflicts should be separate and subsidiary to the
value and credibility of the research.
I would like to thank Ben Yeh for providing overall
suggestions. I would also like to thank Dr. Richard Debski
for helping me determine ethical issues within biomedical
engineering.
REFERENCES
[1] Vallabhaneni V, Want T, He B (2012). “Brain Computer
Interface”. Bioelectric and Neural Engineering (online
article). http://link.springer.com/chapter/10.1007%2F0-30649610-5_3#page-1 pp. 87-115
[2] Shih J, Krusienski D, Wolpaw J. (2012). “Brain
Computer Interfaces in Medicine”. Mayo Clinic Proc.
(online article).
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3497935/.
pp. 268-275
[3] Vlek R, Steines D, Szibbao D, Kubler A, Schneider M,
Haselager P, Nijboer F (2012) “Ethical Issues in BrainComputer Interface Research, Development, and
Dissemination”. J Neurol Phys Ther. (online article).
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