Budny 10:00 L16 IS IT REALLY WORTH IT? Kayla Williams (kaw182@pitt.edu) INTRODUCTION The following is a possible scenario that I could see myself in as a future engineer in which my ethics would be questioned. I am working at a pharmaceutical company, doing research on dissolvable microneedles as a better method of delivering drugs and vaccines to patients. This is a technology that I am passionate about and have been working on for years. We are nearing the end of the research and testing process on animals, and will move to human trials next. The only aspect that we are concerned about is the long-term effects of the materials used in the microneedles after they dissolve in the bloodstream. We have not considered all of the possible interactions between the materials and the human body and, if over a long period of time, these materials will come to harm the patients. My lab is approached with an extremely handsome offer by the company to have these microneedles ready to go onto the market in 6 months so as to beat another company working on the same project and that is close to putting them on the market as well. If we manage to get the microneedles on the market in 6 months, my lab team receives a raise. If we don’t finish in 6 months, and the other company releases the microneedle technology on to the market first, we are told we do not want to know what will happen as a result. We think this could consist of terminating the project, lowering our salaries, or even being fired. As we continue work on the project, we realize that the deadline does not give us enough time to test the long-term effects of the dissolvable materials in the microneedles. Our lab team has a meeting to discuss the issue, and some people suggest fudging the results in order to get the microneedles approved for human trial, and then to be put on the market before the deadline. They reason that the microneedles will pass the human trials because we already know that there are no short-term adverse effects, and any issues that might arise will not be for months or even years later. If we do not make the deadline, we miss out on a huge financial reward, and we risk losing our jobs all for the chance that there might be longterm effects for the patient. What if there aren’t any adverse effects of the microneedles and we miss the deadline all for nothing? But what if we fudge the results and there are health complications that arise in years to come? The company would be vulnerable to various lawsuits as well as my lab team. CODE OF ETHICS In order to better evaluate my ethical obligations in this scenario, I would refer to two codes of ethics in order to determine which canons I would be violating. Those two codes are the National Society of Professional Engineers University of Pittsburgh, Swanson School of Engineering 1 2014-10-28 (NSPE) code of ethics and the American Chemical Institute of Chemical Engineers (AIChE). According to the NSPE code of ethics, I could be in question of violating the first canon of holding “paramount the safety, health, and welfare of the public” [1], but this is not a helpful canon in helping make my decision. When I look at the Rules of Practice category and read the details under the first canon, it says that “Engineers shall approve only those engineering documents that are in conformity with applicable standards” [1], but this is vague. What does it mean “applicable standards?” The microneedles would be extremely applicable in this case, and due to all the benefits of the microneedles, my team of engineers would most assuredly be holding “paramount the safety, health, and welfare of the public” [1]. It is difficult to gauge exactly if I would be in direct violation of these canons, and it would be easy to argue that I would not be in violation of the code, therefore, looking at this code of ethics would not help me in this decision. In addition to the NSPE Code of Ethics, I would reference the AIChE code of ethics since the AIChE has beneath it the Society of Biological Engineering (SBE). Looking at this code of ethics, the obligation to “formally advise their employers or clients (and consider further disclosure, if warranted) if they perceive that a consequence of their duties will adversely affect the present or future health or safety of their colleagues or the public” [2] stood out to me because it explicitly mentions taking into consideration consequences that will affect the future health or safety of the public. However, I can easily make the case, again, that because, in my scenario, there are no adverse effects that we know of, and the only question is whether to put in the extra effort to be sure that there are no adverse effects, this rule of the AIChE code of ethics is no more helpful than the canons of the NSPE Code of Ethics. OTHER CASE STUDIES Looking at other case studies could be helpful, too in deciding the most ethical course of action. Case 1: In the case titled “What’s the Angle?” [3], an engineer’s employee discovers that there are rusty clippings on a building that create the risk of granite blocks falling into the street below and hurting someone. The employee alerts the engineer employer, who then relays this to her employer, but he does not want to mention the rusty clippings because the clippings were not a part of the agreed upon survey he had to complete, and he is about to close a deal selling the building to a client. The money that he will receive from this deal will be enough for him to retire to a 50-acre estate. If the engineer goes behind her employer’s back and tells the client about the Kayla Williams clippings, she is in violation of her contract, and if she does not do anything, her employer promises future work opportunities for her small firm [3]. This case is similar in that the engineer faces the dilemma of having to choose between lying (or omitting information, which I view to be the same thing) in order to reap a reward or telling the truth and risking losing business. Her husband’s response is to do nothing because if she loses her business relationship with her employer, that also means less business for the 15 workers under her who have families [3]. In this situation, I immediately thought I would say something about the rusty clippings because the lives of the people walking by the building are at risk, and the company would face a huge lawsuit if someone is seriously injured or killed. But, the engineer has a small firm, and helping this client could be her big break to get the firm off the ground and expand. There is a good chance that her worker did not assess the situation correctly and that the rusty clippings could be less of an issue than she thinks. But, again, does the risk outweigh the value of a life? That same question arises in my scenario: does me getting a raise outweigh the risk of a patient developing serious health problems in years to come? Case 2: A Lead Product Development Engineer, Keith, is on a team who is also working with a manufacturing company to release a new medical device on to the market. They have been waiting to release this product a long time, and their supervisors are pressuring them to release the product, but they find that they are 6 months behind schedule for releasing the product. Testing has been done, but Keith notices that not everything was documented properly including engineering rationale behind why some tests were avoided in the testing process. However, one of the other engineers on the team sends an email to the company announcing the soon release of the medical device, provided Keith signs the Product Release Authorization (PRA) form. The medical device is a rather low-risk technology and is non-invasive, so Keith struggles with whether to sign the form in the hope that there was a substantial engineering rationale behind avoiding certain tests—and they just weren’t documented properly— or to not sign the forms to avoid the risk that something goes wrong with the device in patients, and blame falls on the team of engineers and the manufacturing company [3]. This case relates to my scenario almost directly because Keith has a choice between allowing the incorrect documentation pass just to reach a milestone for the company or being overly concerned about a device that is low-risk. Because microneedles are low-risk, and non-invasive as well, and the only concern in my scenario is that there might be adverse effects a long time down the line, it is almost the exact same situation. Engineers should be concerned about the risks they put against patients’ lives, but at the same time, improper documentation is trivial in the grand scheme of things just like passing the microneedles on to human trial and avoiding testing long-term effects is trivial since we do not know if there are any adverse effects, what they would be, and how long it would take for long-term issues to arise. OTHER OPINIONS ON ETHICS In the book “Biomedical Ethics for Engineers,” the authors raise the question of what it means to be a professional, and they discuss it with undergraduate students in a professional ethics course at Duke. The verdict was that a professional is someone that the public trusts: “Instead, for professionals, there is an expectation of trust, i.e., credat emptor, on the part of the patient of the patient or client. Engineers fall into the trust category” [4]. This raises a good point because for engineers, especially, people are putting their lives in our hands. They are trusting us to take care of them to the best of our ability. Relative to my scenario, each and every decision I make has to account for the fact that we are expected to value the well-being of the public and any patients that would receive treatment via microneedles. Not wanting to account for long-term effects of microneedles in order to receive a raise is not keeping the patient at heart. But at the same time, I cannot disregard my own desire to have professional success in the future. Another issue is that longterm adverse effects are not inevitable, so we might end up passing up the offer and/or losing our jobs for seemingly nothing. “Engineering Ethics,” by W. Richard Bowen, discusses consequentialism as being key to an engineer’s method of thinking and practice. “There is a tendency for engineers to adopt as a default position in the consideration of ethical problems a calculation of consequences and risks, a calculus of consequences. The philosophical basis of this approach to ethics is termed consequentialism” [5]. This quote essentially says that any engineer can and will account for all possible outcomes of their actions, which is what I must do in my ethical dilemma. I must consider if further down the line a long-term adverse effect will arise in a patient, in which case, I am at fault for not fully considering the consequences of the dissolvable microneedles. Even if we can never truly know how far into the future the long-term adverse effects will occur, we must still carry the burden of having allowed dissolvable microneedles on to the market without being at lease more certain of their safety in patients. This ties back to the last paragraph where I discussed trust being something crucial to the engineering profession. MY PERSONAL VALUES After consulting all of the other documents and sources of information on ethics, at the end of the day, there are two sources that matter the most to me: my dad and the Bible. I grew up in a Christian home, and Christianity is central to the decisions I make in life, thus it is very important to me and my family. Since my dad is a preacher, I would consult him first because not only would he have a lot of helpful advice to offer to me, he would also give me some Scriptures to look at to get me directly involved with what the Bible says about 2 Kayla Williams different issues in life. Essentially, he would tell me to not be concerned about missing out on the opportunity to have a raise in salary or even being fired because God would make a way out of no way. His favorite thing to say to me is “You’re a child of the King” [5], which means as a child of God, I do not have to worry about issues such as losing my job because as long as I pray about it and trust in God to take care of me, everything will work out. Even if I did lost my job, God would still make a way for me, perhaps opening the door to an even greater opportunity. In the Bible, there are tons of Scriptures that would support my Dad’s advice to do the right thing regardless of what man might say the consequences will be. “So we may boldly say: ‘The Lord is my helper; I will not fear! What can man do to me?’” (Hebrews 13:6) “For God has not given us a spirit of fear, but of power of love and of a sound mind” (2 Timothy 1:7). “Only let your conduct be worthy of the gospel of Christ…and not in any way terrified by your adversaries…” (Philippians 1:27-28). “Let nothing be done through selfish ambition or conceit, but in lowliness of mind let each esteem others better than himself. Let each of you look out not only for his own interests of others.” (Philippians 2:3-4). Something else my dad would say is that even if I am fired, I shouldn’t worry because, again, I am a child of the King, and God wouldn’t leave me suffering for long. “When you pass through the waters, I will be with you; and through the rivers, they shall not overflow you. When you walk through the fire, you shall not be burned, nor shall the flame scorch you.” (Isaiah 43:2). “For the Lord will not cast off forever. Though He causes grief, Yet He will show compassion according to the multitude of His mercies.” (Lamentations 3:31-31). CONCLUSION My final decision would be to not fudge the data and just hope to God that I am not fired, and that there are no dire consequences for not meeting the deadline. I cannot put my monetary desires over the value of a life, because that is not fair to a patient. If a health problem develops in a patient, that health problem could end up costing a lot more than any raise I would receive in my salary. I also could not live with myself knowing that the public trusted me with their health and welfare, and I failed them due to selfish desires. As a recommendation to other engineers, I would say it is never worth it. If you even have to ask the question, it is simply not worth it. Do what seems right to you and stick to it, because at the end of the day, you will be rewarded for that. If you do not believe in God, then good ole’ karma will repay you for your commitment and adherence to what is morally required of engineers. 3 Kayla Williams REFERENCES [1] NSPE Executive Committee. (Last Revised 2007). “NSPE Code of Ethics.” http://www.nspe.org/resources/ethics/codeethics [2] AIChE Executive Committee. “Code of Ethics.” http://www.aiche.org/about/code-ethics [3] “What’s the Angle? (Case 1010)” http://www.depts.ttu.edu/murdoughcenter/products/cases.ph p [4] “To Release or Not to Release: An Engineer’s Perspective.” http://biodesign.stanford.edu/bdn/ethicscases/21releasequesti on.jsp [5] Daniel Vallero, Jonathan T. Simpson. (2007). Biomedical Ethics for Engineers. (eBook). Pp. 139-141. [6] C. Williams. (2025, March 15). Conversation. [7] W. Richard Bowen. (2009). Engineering Ethics. (eBook). Pp. 29-41 ADDITIONAL SOURCES C.I. Scofield. (2002). The Scofield Study Bible, New King James Version. New York, New York: Oxford University Press. (print book). 4