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Page 1: ETHICS IN BIOMEDICAL ENGINEERINGdaf93/WA3.pdf · ETHICS IN BIOMEDICAL ENGINEERING ... must not only follow the code of ethics as described by the ... technology meant solely for medical

Budny 10:00 R13

University of Pittsburgh, Swanson School of Engineering 2015-11-03

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ETHICS IN BIOMEDICAL ENGINEERING Daniel Fulmer ([email protected])

INTRODUCTION

The occupation of engineering is one of, if not the most, difficult professions to remain completely ethical. Some of the reasons are that “engineering is an important and learned profession. As members of this profession, engineers are expected to exhibit the highest standards of honesty and integrity. Engineering has a direct and vital impact on the quality of life for all people. Accordingly, the services provided by engineers require honesty, impartiality, fairness, and equity, and must be dedicated to the protection of the public health, safety, and welfare. Engineers must perform under a standard of professional behavior that requires adherence to the highest principles of ethical conduct” [1]. I am focusing more specifically on the ethics in biomedical engineering which has its own set of canons and obligations to follow. “Biomedical engineering is a learned profession that combines the expertise and responsibilities in engineering, science, technology, and medicine” [2], so you must not only follow the code of ethics as described by the National Society of Professional Engineers (NSPE), but also an extra, more detailed set of guidelines that need to be followed by biomedical engineers at all times. “The rapidly advancing field of synthetic biology seeks novel solutions to old problems in environment, energy, and health through the integration of biology and engineering knowledge and know-how. The goal is to engineer biological machines—biological systems that do not occur in nature—to perform human-directed functions” [3]. In the case of engineering sensation in artificial limbs with the use of electrodes and electrical pulses, many ethical dilemmas can arise. It is the duty of a biomedical engineer to overcome these obstacles and make the ethical decision, which may not always be the “right” decision in some people’s eyes. .

CASE STUDY

Biotech is a company that focuses on major dilemmas in the biological field. It uses some of the brightest engineers in the world to come up with solutions to these seemingly impossible problems. Recently they have been working on bringing back sensation to patients who have prosthetic limbs. Specifically, they use electrodes connected to three major nerves in the arm that send electrical pulses to the brain, mimicking senses.

Man-Made

Biomedical engineers, like the ones at Biotech, focus much of their effort on the invention and advancement of technologies that improve life for people. Engineers know

that “the potential range of applications for these systems is vast, and the potential value of these applications—in effectively and efficiently addressing environmental problems, energy needs, and therapeutic goals in health—is enormous” [3]. This same information about synthetic biology is also “well known to policymakers and governmental agencies, including the National Science Foundation (NSF), which is funding research in the field. These policymakers and governmental agencies are also concerned about the ethical and policy problems that may be associated with the development and application of these machines—and about our capacity to identify, understand, and address them” [3]. This comes into effect when dealing with the restoration of senses to patients with artificial limbs. The electrode/electrical pulse system that was created to mimic sensation is seen as a great invention, but because it is a man-made machine replacing a naturally occurring process, an ethical dilemma is sure to arise. Biotech faced a major ethical controversy dealing with this. A large corporation confronted them about buying their technology and turning it into a human enhancement tool instead of an aid to injured patients. They began to realize that “with continuing advances in science and technology, some of the basic parameters of the human condition might be changed in the future. One important way in which the human condition could be changed is through the enhancement of basic human capacities” [4]. While they would make a sizable increase in income if they decided to partner with the corporation, it would stray from the original reason they were working with the technology.

Dangerous Procedure

In order to get this technology to work, the doctors and engineers must surgically implant an electrode cuff on three of the major nerves of the arm. This procedure is unique to the technology, so it is difficult and can only be done by a clinical specialist. They are the only individuals with the expertise and experience necessary to successfully complete this task [5]. It turns out the day of one of the surgeries to insert the electrodes, the specialist isn’t there, but my colleagues feel confident that I can perform the operation just from watching the main doctor multiple times. I however believe that this is a poor decision because it is a dangerous procedure and if done incorrectly could cause further injury or even death to the patient.

Confidentiality

After the successful surgery and implantation of the three electrodes in a patient’s arm connected to his prosthetic limb, and careful adjustments to the electrical pulses that

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create the sensation, the team of biomedical engineers at Biotech were ready to share their accomplishment to the world. They entered their patient in various medical expos, wrote extensive case reports, and even used him in real life demonstrations. In biomedical engineering it is very important for engineers to get their work out to the rest of the scientific community, but that occasionally brings up ethical dilemmas. In this case the patient with the technologically advanced prosthetic started to feel uncomfortable with all the press and observation he was receiving. It was not only the fact that he was being shown off as an object, but also that a lot of his personal information was being given out as part of the research. The patient was under the assumption that all his information would be protected under doctor patient confidentiality, which is based off ethics not law [6]. Although in some cases it can be “called upon in legal matters to establish the extent by which ethical duties of confidentiality apply to legal privilege” [6] It is this legal privilege which “involves the right to withhold evidence from discovery and/or the right to refrain from disclosing or divulging information gained within the context of a special relationship,” [6] in this case the bond between the patient and the biomedical engineers that performed the procedure on him. By breaking this pact, an an ethical problem arises for the engineers. Do they share their work with the world, or respect the wishes of the patient that helped them get to this point?

CODES OF ETHICS

The field of biomedical engineering has not been around very long, so the codes of ethics made specifically for this concentration is limited. This is even more relevant for synthetic biology, which the electrode and electrical pulse technology is an example of. It may be considered “the most daring step taken in scientific and, indeed, human history, but it has received relatively little attention from the bioethics community” [7]. This is surprising because “the field offers the potential for unimaginable advances in human development, yet also has potentially great destructive power” [7].

Decisions

Biotech had to deal with three different ethical dilemmas, each of which brought up a different problem. In the first case it was the idea of taking a man-made technology meant solely for medical purposes and turning it into a commercial upgrade for human enhancement. If I was the engineer in this situation, I would decide against selling the technology. Although it would be a very profitable way to go, it goes against the National Society of Professional Engineers’ code of ethics. It states that “engineers shall not promote their own interest at the expense of the dignity and integrity of the profession” and also “shall not be influenced in their professional duties by conflicting interests” [1]. If I

took the deal from the corporation, I would be promoting my own interest and having my work influenced by those conflicting interests. In terms of the impact on me, I would likely be fired from my job at Biotech and ostracized by the engineering community for taking my own goals ahead of the goals of the organization. All the individuals involved with this technology, mostly the patients with prosthetics, would be majorly affected by this decision. Selling the idea of this technology that was made specifically to help them get back sensation in their prosthetic limb would cause them to either not get the treatment at all, or have to fight with all the other normal people who just want the technology to enhance themselves. It is not fair that people who actually need the technology just to function on a daily basis would be subject to inconvenience because of one selfish engineer’s decision. Biotech and all of its workers would be impacted from this decision also. They would lose all of their patents and holds on this technology along with losing any money that could have been made of of it. They also would be letting all of their patients down. These people with artificial limbs looked to Biotech for a solution to their problem. With that gone they could not get the help they rightfully deserve. The second case contains and even larger, more important ethical dilemma. It deals with performing a dangerous procedure without the person most qualified to carry it out. This breaks the National Society of Professional Engineers’ code of ethics by “not being guided in all their relations by the highest standards of honesty and integrity” and “not advising their employers or clients when the believe a project will not be successful or come with complications” [1]. When I (as the engineer) did not believe that I was able to perform the electrode implantation surgery successfully, I was obligated to tell my superiors and the patient that fact. Not doing so could get me fired for negligence. It might also cause Biotech to be liable to lawsuits brought forth by the patient who was operated on. In terms of the individual patient himself, he could have been injured more seriously or even lost his life due to me performing the surgery instead of the most qualified engineer on staff. This example also goes against the Biomedical Engineering Society code of ethics. If I chose to perform the surgery anyway, this decision would not “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” [2]. I would not have respected the rights of the patients that underwent the surgery, making me responsible for anything that happened to him. This also meant I did not “consider the larger consequences of their work in regard to cost, availability, and delivery of health care” [2]. It is very unethical to not take into account all the outcomes, positive or negative, that come out of the decision an engineer made. Choosing to do the surgery would be an example of a poor decision.

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The third case includes ethics that are very important to how the biomedical engineers handled the patients case and how they presented it to the engineering community and public. According to the National Society of Professional Engineers’ code of ethics, “engineers shall not disclose, without consent, confidential information concerning the business affairs or technical processes of any present or former client or employer, or public body on which they serve” [1]. The biomedical engineers of Biotech broke this rule by giving out the patient’s personal information without his okay. This can bring about many consequences for all parties involved, starting with the engineers getting fired from Biotech and leaving both them and the organization open for lawsuits. The patient may be continuously bothered and harassed by the engineering community about the technology he was equipped with. Additionally, much of his personal information is out in the public, which can cause negative effects on his life. In most cases, consequences are so bad that the ethical dilemmas are easily overcome, but in this instance there are some positives. For the engineering community, sharing this information would enable the idea of this technology to become more widespread and eventually used on more people who would benefit from regaining sensation in their prosthetic limbs. That is what makes the ethics in this case more difficult than the others. The decision is a lot clearer once the Biomedical Engineering Society code of ethics is referenced. It states that biomedical engineers must “regard responsibility toward and rights of patients, including those of confidentiality and privacy, as their primary concern” [2]. Once the engineers at Biotech disregarded the patient’s privacy, they put themselves in a situation of poor ethics. If I were one of the biomedical engineers in the instance, I would first ask the patient for his consent on releasing this information and then go about presenting the case to my engineering peers without divulging any personal information about the patient. This would be the most ethical thing to do.

Recommendations

After researching the ethics involved with biomedical engineering, I have learned a lot that can help me as a future engineer. I hope I can also use my knowledge to recommend how others should approach ethical dilemmas. It is my duty as set forth by the Biomedical Engineering Society code of ethics to “honor the responsibility not only to train biomedical engineering students in proper professional conduct in performing research and publishing results, but also to model such conduct before them” [2]. In my professional opinion I would say when faced with a problem dealing with ethics, first think about all the consequences that may arise, positive or negative. Then compare all of those to the codes of ethics that are relevant, including the the National Society of Professional Engineers and whatever engineering specializations are also involved. If even one code is broken in the slightest it is an unethical decision and

you must either find an alternative or abandon the problem entirely. It is better to remain ethical and not trigger any consequences, than do something that may get you or someone else get in trouble.

CONCLUSION Ethics in engineering is extremely important. It is very likely that all engineers will at some point during their career be faced with an ethical dilemma that they must come to a decision on. This is why they must not only be familiar with the multiple codes of ethics, but also be able to understand and follow the canons they represent. The case studies I presented were specifically focused on biomedical engineering and an electrode and electrical pulse technology that returns the sense of touch back to patients with prosthetic limbs. This dealt with many ethical dilemmas. Engineers must work through these problems and come up with the correct solution because there is a lot at stake, not only for them, but the rest of the world.

REFERENCES

[1] National Society of Professional Engineers. (2007). “Ethics.” Code of Ethics for Engineers. (online article). http://www.nspe.org/resources/ethics/code-ethics [2] Biomedical Engineering Society. (2004). “Ethics” Biomedical Engineering Society Code of Ethics. (online article). http://bmes.org/files/2004%20Approved%20%20Code%20of%20Ethics(2).pdf [3] R. M. Berry, K. Kinlaw. (2013). “Ethical and Policy Problems in Synthetic Biology.” Online Ethics Center. (online article). http://www.onlineethics.org/Resources/Cases/27581.aspx [4] N. Bostrom, R. Roache. (2007). “Ethical Issues in Human Enhancement.” New Waves in Applied Ethics (online article). http://www.fhi.ox.ac.uk/ethical-issues-in-human enhancement.pdf [5] Stanford Biodesign. “Ethical Case Studies in Biodesign.” The Clinical Specialist. (online article). http://biodesign.stanford.edu/bdn/ethicscases/14clinicalspecialist.jsp [6] USLegal. (2014). “Legal Healthcare.” Doctor Patient Confidentiality. (online article). http://healthcare.uslegal.com/doctor-patient-confidentiality/ [7] P. Heavy. (2013). “Bioethics.” Synthetic Biology Ethics: A Deontological Assessment. (online article). http://web.b.ebscohost.com/ehost/pdfviewer/pdfviewer?sid=4400c960-bead-4143-9eea-53cba3c37e9c%40sessionmgr110&vid=17&hid=109

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ADDITIONAL SOURCES

J. M. Basart. (2013). “Scientific Engineering Ethics.” Engineering Ethics Beyond Engineers’ Ethics. (online article) DOI 10.1007/s11948-011-9293-z Web Guru. (2013). “Ethics Case Studies.” It Only Takes a Second (online article) http://www.webguru.neu.edu/professionalism/case-studies/it-only-takes-second

ACKNOWLEDGMENTS I would like to thank my friends and family for making this paper possible. They kept me from procrastinating and giving up even when I really wanted. I would like to give a special shout out to Maddie for helping me edit this paper and make it not nearly as bad as it was before. I would also like to thank Sam for motivating me to keep writing and letting me wait until the last minute to finish this paper.

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