ENGR0011/0711 Section

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ETHICS IN BIOENGINEERING: ISSUES WITH THE BIONIC EYE

Natalie Garda ()

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Natalie Garda

INTRODUCTION

As engineers, we face various ethical dilemmas in our everyday work environment. These setbacks can be anything ranging from political issues, to public safety concerns, to problems with colleagues and bosses in the workplace. Engineers are required to follow a very specific code of ethics. We impact the everyday lives of virtually everyone living around us in the world and necessarily must take the rules and obligations of the engineering field very seriously. The one statement that really encompasses the entire idea behind the code is this: “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” [1]. We take the lives of millions of others into our hands when designing products and/or services, and taking any back-roads to accomplish a goal potentially places all of those lives in grave danger.

As a bioengineer, this is especially true for my profession. We work very closely with those in the medical field, and consequently the patients under medical care. Anything done underhandedly to get a bioengineered device through to the market could very well result in immediate life-changing consequences to the patient that the device was intended to help. Recently, I encountered an ethical dilemma in my workplace in which I was forced to reference the codes of ethics. Although some decisions are hard to make as an engineer, the codes help tremendously to guide you in the right direction in your ultimate choice in the end.

In addition to the codes though, engineers must also consider previous clinical cases that provide insight into the outcome of a certain situation that they may similarly find themselves in. Lastly, engineers must also keep a network of people around to confide in if necessary. These people need not be engineers, but rather they must be individuals that the engineer feels comfortable turning to in a time of need. The following information outlines the different references that an engineer should keep available at his or her fingertips in the case that he or she finds oneself in a difficult ethical situation.

My Ethical Dilemma

Over the past few years, I as a biomedical engineer have worked on a project to advance the efficiency of the artificial eye (also known as the “bionic” eye). Recently, my boss asked myself and my teammates to push to get our product tested and used on a willing “trial patient” so that it could be put on the commercial market as soon as possible. Although the original product, the Argus II, had already been approved for use in humans and put on the market, I did not feel comfortable pushing our advanced product through for use

quite yet. It was a difficult decision to refuse to follow my boss’s orders to promote our device since it has the potential at this point to help so many individuals who suffer from visual impairments. However, it also is not guaranteed to be safe at this point, and after speaking with a few individuals in the field and referencing the engineering codes of ethics, I feel that ultimately I made the ethical decision.

THE ENGINEERING CODES OF ETHICS

Across the board, all engineers must ultimately follow the same general code of ethics, which includes all of the essential fundamentals important to engineering, as well as the major rules of practice, and any professional obligations that engineers must abide by [1]. However, each individual branch of engineering has its own simplified code of ethics of which those engineers in that specific field must also follow. Most of the points of the codes helped lead me to my final decision to go against my boss’s orders; other points did not contribute to my choice in the slightest. Below are highlighted the fundamental canons that either did or did not aid me in my ultimate decision to refuse the request of my boss.

Helpful Canons

The most helpful canon that impacted my ultimate decision was the one that stated that engineers shall, “Hold paramount the safety, health, and welfare of the public” [1]. When considering the safety of our advanced product, I was still having some doubts. Just based upon this fact in relation to the code, I determined that it was against the code to approve for the product to be placed on the market for trials in patients when I had high doubts regarding the safety of the device.

Another two canons which helped me to address the ethical approach to my choice were that engineers may “issue public statements only in an objective and truthful manner” and “avoid deceptive acts” [1]. By agreeing to allow the product to be sent out for testing in humans despite the fact that I found the product potentially unsafe would have gone against the requirement to be truthful in all cases. I would have been deceiving those patients in need of the device if I had approved of the product and declared it safe for utilization in humans when in fact I highly doubted this. In addition, I would have been going against the biomedical engineering health care obligations canon which states that engineers must respect the rights of patients and consider the possible negative consequences of their work [2].

The final helpful canons that I was able to reference were those that require engineers to be honorable and responsible in order to uphold the reputation not only of an employer or client, but that of the entire profession as well [1]. Pushing for an unsafe product to go out onto the market could have damaged not only my reputation, but the reputations of my employer as well as my teammates and the entirety of my engineering discipline as well.

Unhelpful Canons

The only canon from the general engineering code of ethics that did not apply to my issue states that engineers must “perform services only in areas of their competence” [1]. Since the product is completely in my line of work and I am qualified to create such devices, I would not have been out of line in a sense of competency. In the Biomedical Engineering Society Code of Ethics, the canon addressing training obligations was also very unhelpful in helping me to formulate an ethical decision. Since I am not in a branch of my field which requires me to train others, this entire canon discussing the appropriateness of what to convey to trainees did not contribute at all to my judgment [2].

CLINICAL CASES

Other beneficial resourcesthat engineers can reference when faced with an ethical dilemma are case studies. These documents outline previous cases dealing with ethical issues and address questions that come up in many similar circumstances. They introduce a different perspective and give insight into potential outcomes that other engineers may not have originally thought of.

For example, in one case regarding a device to help attach vessels to the aorta of the heart more easily during surgery many questions arise about the usefulness of such a technology. For device in early stages, questions such as “Does developing stepping stone technologies really make sense from a business perspective?” must be addressed [3]. It most likely makes more sense to hold off on the “stepping stone” and create a more long-term, permanent fixing device. This applies directly to my situation in developing the artificial eye; I had to ask myself, “Does it make sense to put something on the market that we will need to change in the near future anyway?” This will cause people/patients to doubt our products if we constantly have the need to alter them to improve them.

Another question that many of these case studies consider is, “Who will be affected by the ethical decision and how?” [4, 5]. For instance, a study based upon research and the false publication of information reflects upon how that particular issue impacts everyone associated with the false publication, as well as any members of the general public who read the article and believe what is said.

A concluding case study that I personally found to be very influential deals with the ethics of how the public reacts to decisions in the engineering discipline. Post 9/11, there was a bioterrorism scare in which U.S. governors and officials contracted anthrax from letters that were sent to tem laced in Bacillus anthrasis spores [6]. This caused the general public to become very panicked about the potential threat of a bio terroristic war and showed how the public reacts to the worst possible situation in particular in an engineering case/issue.

ETHICS REFERENCES SPECIFICALLY FOR BIOENGINEERS

In comparison with all of the other branches of engineering, bioengineering is by far the most complex of them all when it comes to ethics associated with the field. Instead of taking the natural properties of matter and energy resources and fitting them for human use, bioengineering actually “extends engineering theory and practice into the lifeworld… It makes the resources of life available to life itself” [7]. Because of this fact, bioengineers must self-reflect upon their decisions much more than the typical engineer would.

Carl Mitcham writes multiple different examples of ethics in bioengineering, which he makes widely available to anybody who needs to reference them. He also addresses in another article that “the complexity of formulating a bioengineering ethics arises from the need of bioengineering to be coherent not only with the ethics of engineering but also with those of biology, medicine, and the physical sciences” [8]. Bioengineering encompasses multiple different fields of study and must necessarily include all of the codes of ethics associated with each branch. The greater issue though then becomes the fact that overlapping ethics leads to conflicting views and a sense off confusion as to what is correct or incorrect will arise more often.

Due to the complexity of the ethics specifically associated with bioengineering, the additional references available become very useful and important and should be consulted often whenever an ethical issue arises.

PERSONAL REFERENCES I TURNED TO

As an engineer, it is important to confide in many different people and sources in order to get outside assistance and many varying opinions. This is especially true when dealing with a difficult decision.

Throughout my decision making process in this specific case, I contacted a few people who have helped me throughout the course of my engineering career. I first contacted Shawn Kelly, a professor at Carnegie Mellon University and one of the original designers and contributors to the artificial eye. He advised me to hold off on any decision to move forward with trials of the newly advanced product until I found it appropriate. One question that he asked me was, “Would you rather sacrifice the life of someone else for your own profitability, or sacrifice the life of your device at the expense of another person’s well-being?” [9]. This really struck me deep and ultimately made my decision for me; I was not about to put another person’s health at risk for any reason, whether it meant losing my job for not following orders, or losing the support of my team for failing to push forward to get the device we worked so diligently on approved.

Another individual that I spoke with in my confused and indecisive state was my cousin Katie, whom I am very close with. I told her how my teammates and I had worked so hard on the advancements put into the Argus II, and my employer wanted it put through to the trial levels. I also informed her of my concerns though. She was very helpful and told me not to rush through anything. She went through a law degree, worked as a lawyer for many years, then decided to return to school to be a doctor. She explained to me that rushing through to the next stage of something, whether it be life in general, or something at work was completely unnecessary [10]. As many people as our device could potentially help in its early stage that it is currently in, she convinced me that it would, without a doubt, help twice as many people if we decided to hold off and perfect the device before sending it out for trials.

CONCLUSION: MY NOTE TO OTHER ENGINEERS FACING ETHICAL DILEMMAS

Engineers must have a wide range of references to turn to for reference and/or assistance when they come to an issue in their line of work. While the codes of ethics are usually helpful, an array of close friends or family is also necessary to keep close by to discuss more personal connections to an engineering issue. Occasionally, a problem within your engineering discipline may not be answered simply through the code of ethics that you are expected to follow. Rather, the issue might hit closer to home for an engineer, who begins to think more about his or her morals than the codes. At this point, no information about previous cases, similar issues, or code regulations will help an individual to make a smart decision. Instead, one will need to turn to those people that he or she is closest with and confide in them for assistance, whether that person be an engineer or not.

No matter what the ethical issue or setback may be, engineers must be able to confide not only in the codes of ethics in engineering but also in one another. No one branch of engineering can work independently of itself; each separate field requires at least one other to make it truly effective and the ability to confide in the members not only of your own branch but of other branches as well is vital to the success of an engineering group.

REFERENCES

[1] "National Society of Professional Engineers (NSPE) Code of Ethics."Encyclopedia of Science, Technology, and Ethics. (2005). Vol. 4, C. Mitcham, Ed. Detroit: Macmillan Reference USA. (online reference). pp. 2189-92

[2] "Biomedical Engineering Society Code of Ethics."The Biomedical Engineering Society. (2004). (online reference).

[3]“Incremental Development.” Stanformbiodesign. (online article).

[4]“ ‘Borrowing’ Without Permission.” webGuru Guide for Undergraduate Research. (online article).

[5]“It’s All About Sharing...”webGuru Guide for Undergraduate Research(online article).

[6](October 2, 2013). “Microbiologists Respond to Bioterrorism.” Online Ethics Center for Engineering. (online article).

[7] C. Mitcham. (March 1990). “Ethics in Bioengineering.” Jornal of Business Ethics. (online article). 227-231

[8]G. Bugliarello. (2005). ”Bioengineering Ethics.”Encyclopedia of Science, Technology, and Ethics. (online article). p.190-193

[9] S. Kelly. (2024, January 29). Email.

[10] K. Hanak. (2024, January 23). Interview.

ACKNOWLEDGEMENTS

I would like tothank my writing instructor, Emelyn Fuhrman for her helpful suggestions in my writing assignment 2, which helped to contribute to this paper. I would also like to thank Adam Cotter for revising my paper. Finally, I would like to thank my cousin, Katherine (Cooper) Hanak for her assistance and support through my pursuit towards a bioengineering degree.

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