Budny 10:00 R16 ETHICS AND NEURAL PROSTHETICS Bradley Alderama (bpa14@pitt.edu) cochlear implant model for clientele use. “A cochlear implant is a neural prosthetic that provides a sense of sound to profoundly deaf individuals” [5]. Cochlear implants are a modern technology that Stryker, in this scenario, wants to develop and put on the market. The implants are very profitable because there are no other alternatives for individuals with severe hearing loss. The Stryker corporate office wants to have a prototype ready by the end of the month and a marketable device by the end of the year. My team and I have been working on this project for several months conducting research and animal experimentation but believe that the device is still not ready for human implantation. Our supervisor goes ahead and approves of the device even though he knows that there isn’t sufficient research and test are not past animal experimentation. He also demands that our group omit the fact that the cochlear implant is still not ready for clientele use in our report. He reasons with our group saying that by cooperating and finishing by the deadline, we would not be in trouble with corporate and our jobs would not be in jeopardy. He also reasons that by releasing the product sooner, we would also help treat the profoundly deaf with the technology sooner. INTRODUCTION TO NEURAL PROSTHESTIC ETHICS What defines ethics and is there a certain code that we, as engineers, have to go by? Why should engineers, the problem solvers of the world, have to care about ethics? Even in our everyday lives, we all have ethics or morals that we go by. Engineers, then, should have ethical codes and morals to influence the decisions they make. Whenever a dilemma arises where someone feels conflicted about whether to do the “right” thing or the practical thing, it is labeled as a grey area. However, engineers are still people and struggle making decisions that are in this grey area. For example, countless deadlines need to be met and if those deadlines are not met by the engineer, it could mean they are out of the job. Alternatively, a product that needs to be done in a certain time frame may be rushed and fallible because of complications that arise during testing [1]. Newer technologies, such as neural prosthetics, are not untouched by these ethical dilemmas. A neural prosthetic is defined as a “device that supplants or supplements the input and/or output of the neural stimulus” [2]. In other words, neural prosthetics offer a way to bypass neural deficits and restore motor, sensory or cognitive disabilities. The technology of neural prosthetics offer a plethora of ethical dilemmas. If the surgery for neural prosthetics is done wrong or the technology is not up to code, could make the patient’s disability even worse. The use of these prosthetics could also be viewed as playing God and modifying a human not helping it. Studies done by research in Germany, showed that the biggest arguments against prosthetics is that more research needs to be done before put into use and the dilemma of informed consent [3]. All of these situations, show why it is important to have a code of ethics that could help guide engineers. Guidelines such as the National Society of Professional Engineers Code of Ethics are helpful for making decisions in the grey area. Ethical dilemmas can be seen in both minimal and significant topics and can have severe consequences if the wrong decision is made. ETHICAL DILEMMAS “Engineers must be dedicated to the protection of public health, safety and welfare”. According to the National Society of Professional Engineers, engineers are tasked with improving the world by making sure they aren’t worsening it while striving to achieve that goal [6]. In the case of our scenario, there are ethical dilemmas that the Stryker team have to hope with and that violate this code. The first questionable act viewed in the scenario is that my supervisor approves of the device even though he knows that it is not ready for implantation. The Biomedical Engineering Society code of ethics is helpful to use as a barometer to decide whether the action is ethical or not. “Biomedical engineers are expected to use their knowledge, skills and abilities to enhance the safety, health and welfare of the public” [7]. The Biomedical Engineering Society wants their engineers to improve society and not aim for the most efficient or the easiest solution. The BMES also states that biomedical engineers in the health field are responsible for the rights of patients. To put it simply, my first priority, as an engineer, is not to develop the most cutting edge technology but rather make sure that patients are being examined and researched in an ethical manner. In this case, both the NSPE and BMES codes are applicable. The supervisor clearly has no regard for the negative consequences for approving a potentially faulty device. If the cochlear implant turns out to be faulty due to insufficient testing, patients could potentially have their SCENARIO Imagine that I am a biomedical engineer working for Stryker Corporation in Michigan. “Stryker is a company that strives for advancement and is a global leader in medical device industry” [4]. The company stresses on helping their patients live healthy lives and speedy recovery through their devices. Some of the company’s latest devices are neural prosthetics that need to be surgically implanted. My supervisor assigns me to a group tasked with developing a University of Pittsburgh, Swanson School Engineering 2015-11-03 1 Bradley Alderama hearing worsen. This would violate the obligation of engineers to use their knowledge to enhance the safety and health of the public. A similar scenario involves a case study with X-Med, a corporation that specializes in medical devices. The current X-Med project was postponed previously because of a complication with the device. The project manager approves of the device even though there still may be a technical issue. The lead product development engineer is fearful that there could be negative consequences because the project manager approved of it prematurely [1]. This case is very similar to our scenario because a superior chooses to accelerate a project so that they do not get in trouble. According to Canon 1A of the NSPE code, “if an engineer’s judgement 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]. My primarily belief is that even though my supervisor could potentially save our jobs or even boost my reputation by releasing the latest technological project, it still violates the NSPE code of ethics. The Stryker Company may still believe that innovation is the utmost priority but, in the case of an engineer, it is the safety and welfare of the public. In addition, the code of ethics help instruct me with what action to proceed with. Because the supervisor is approving a medical device that could potentially endanger someone’s life, the appropriate action would be to report my supervisor to a higher up. In addition to the danger to public safety, the falsification of records is an apparent ethical dilemma for the Stryker workers. Falsification can be used to garner reputation or to shortcut publication pieces as in the case of the undergraduate student, Lisa. In this specific case study, a student is reading through a research article in the current issue of Cell and believes that the data may have been edited or fabricated. She is faced with the dilemma to report it to her mentor or keep it to herself. Cell is a very well respected scientific journal and she has doubts that an organization of that stature could fabricate their information [8]. Deceitful tactics are also used to cut corners and save money and time on projects. For example, Rashid, an engineer from City Technical Institute works at a construction firm called Rome Builders Incorporated. Rashid is new at the job so he gets tasked with making sure that all the workers at the projects are accounted for. However, he notices that there is a flaw in the building plans. Some of the steel beams that need to be coated cannot be coated because they are covered by the walls. Rashid then sees that the coating supervisor lies and says that all the beams have been accounted for. Rashid is facing an ethical dilemma because of the deceitfulness by the coating supervisor [9]. In both Lisa’s and Rashid’s case, the information that a supervisor should be accountable for is withheld or modified. Engineers are responsible for issuing public statements only in an objective and truthful manner [6]. In our scenario, the supervisor wants me to fabricate and falsify the research and results that our team has done on cochlear implants. This however is unethical according to the NSPE code. More specifically, it violates the professional obligation of engineers to avoid the use of statements containing material that is a misrepresentation of fact or omits a fact. Our supervisor wants me to omit the fact that the cochlear implant device has only been tested on animals. By demanding that our group send out a uniform report on the technology, he is asking us to endorse this deceitful information. This violates the NSPE canon that states “An engineer shall not permit the use of name with any person they believe is engaged in fraudulent or dishonest enterprise”. The supervisors at Stryker care only for their reputation or making a quick buck so it would be unethical to endorse the cochlear implants according to NSPE [6]. Biomedical engineers involved with research must comply with all legal and ethical guidelines and respect the rights of human and animal subjects [7]. By modifying the information, it would mean that I would be withholding information from human subjects about their cochlear implant surgery which would be immoral. There are many problems that can arise from being an engineer, but by following code of ethics I am able to determine what is right and wrong. ETHICAL DEBATE OVER NEURAL PROSTHETICS Not only do ethical dilemmas arise from situations but they can also arise from the technology itself. Neural prosthetics are used to help repair sensory, cognitive and motor disabilities but they cannot completely treat them. Many ethical questions came about because of neural prosthetics. Neural prosthetics are still relatively new field so many people are hesitant over this “miracle technology”. A study was conducted in Germany to gauge the current view of neural prosthetics and if there was any negative stigma towards the technology. Two hundred and eighty six articles dating from 1999 to 2009 were analyzed in the study. It was shown that the majority of articles were uncritical and focused on positive aspects. Out of the 286 articles, 146 shed a positive light on neural prosthetics. The remaining articles were predominantly neutral with negative view points being in the minority. The main things to pull from the studies were the ethical dilemmas with using neural prosthetics. Informed consent was a hot topic throughout the various articles [3]. Informed consent is when someone such as an engineer or a doctor decides to use the technology/treatment on an individual who cannot decide from themselves. Many times these individuals are in a coma and are mentally ill so other people make the decisions for them. Another ethical dilemma would be, as mentioned previously, that the technology is still in its infant stage and any surgeries done now could have long term effects and consequences. For both of these dilemmas, a code of ethics does not give an answer in black in white as before. The decision on whether or not giving neural prosthetics to an individual who is unable to give consent is ethical or not is 2 Bradley Alderama subjective. The NSPE and BMES code of ethics are also unable to tell engineers whether or not a technology is suitable for public use. Any variable could go wrong no matter how much testing is done and so there needs to be a point where we as engineers say that it is ready for the public. The NSPE and BMES codes do not, however, give any specifications just general moral guidelines to follow. For different companies and individuals, they will have different codes and regulations to follow. I would like to delve in to the social ramifications of the technology, more specifically, cochlear implants. Cochlear implants cannot completely fix deafness and do not guarantee improved language or cognitive development [10]. The ethical debate is whether we should even insert implants into the hearing impaired because they still remain partially deaf whilst still requiring accommodation. Because of this, many members of the deaf community oppose implants because they threaten their language and culture without fixing deafness. The ethical codes are also unhelpful in this case because the idea of the protection of public health, safety and wealthy can be viewed in two ways. As a reminder, engineers are expected to “use their knowledge, skills and abilities to enhance the safety, health and welfare of the public” [7]. Pertaining to the debate on whether implants are good for society, the engineers could see cochlear implants and neural prosthetics in general, as helping the overall population. The deaf community, however, view the cochlear implants as detrimental to society because it takes away from their own identity and tries to acclimate them into society without fixing the problem completely. In my opinion, the best course of action would be to research the technology for several more years and before then, only let individuals in dire need undergo the implant surgery. CONCLUSION Engineers should employ both their own judgement and several code of ethics when making a decision. For certain scenarios, a code of ethics is able to give a concrete answer on whether the scenario is ethical or not. Code of ethics like those of the NSPE or BMES, also give instructions on how to deal with an unethical project/decision. However, these codes are not always applicable because many decisions/acts have opposing sides like in the case with the deaf community and engineers. As an engineer, ethical dilemmas will always be prevalent because of our constant desire to constantly improve and become more efficient. The best course of action for the future, I believe, is to strive for advancement of society while still keeping the safety of the public as the number one priority. 3 Bradley Alderama REFERENCES ACKNOWLEDGEMENTS [1] “To Release or, Not to Release: An Engineer’s Perspective.” (2015). Stanford Biodesign. (Website). http://biodesign.stanford.edu/bdn/ethicscases/21releasequesti on.jsp [2] E. C. Leuthardt, J. L. Roland and R. Z. Wilson. (2014). “Neuroprosthetics.” The Scientist. (Online article). http://www.thescientist.com/?articles.view/article No/41324/title/Neuroprosthetics/ [3] K. Laryionava, D. Gross. (2011). “Public Understanding of Neural Prosthetics in Germany: Ethical, Social and Cultural Challenges.” Cambridge Quarterly of Healthcare Ethics. (Online article). DOI: 10.1017/S0963180111000119 pp 434-439 [4] “Company History.” (2015). Stryker. (Website). http://www.stryker.com/enus/corporate/AboutUs/History/ind ex.htm [5] “Cochlear Implants.” (2013). National Institutes of Health. (Online article). http://report.nih.gov/nihfactsheets/ViewFactSheet.aspx?csid =83 [6] “NSPE Code of Ethics for Engineers.” (2015). National Society of Professional Engineers. (Website). http://www.nspe.org/resources/ethics/code-ethics [7] “Biomedical Engineering Society Code of Ethics.” (2015). Biomedical Engineering Society. (Website). http://bmes.org/files/2004%20Approved%20%20Code%20o f%20Ethics(2).pdf [8] J.R. Young. (2008) "Journals Find Fakery in Many Images Submitted to Support Research." Chronicle of Higher Education. http://chronicle.com/free/2008/05/3028n.htm [9] “Roman Holiday.” (2015). National Institute for Engineering Ethics. (Website). http://www.depts.ttu.edu/murdoughcenter/products/cases.ph p [10] C. Lee. (2012). “Deafness and Cochlear Implants: A Deaf Scholar’s Perspective.” Journal of Child Neurology. (Online article). DOI: 10.1177/0883073812441248 pp. 821823. A special thanks to those who helped me construct this paper on the ethical dilemma of the use of neural prosthetics. I would like to thank Nancy Koerbel and the instructors of the O’Hara Writing Center. I would also like to thank Dr. Dan Budny, Ms. Jill Harvey and the Swanson School of Engineering staff and faculty. 4 Bradley Alderama 5