Schaub 4:00 R10 BIOPRINTING: THE ETHICS OF 3D PRINTED ORGANS Katie Poduska (ksp37@pitt.edu) THE SCENARIO The year is 2030, and I have been working as a bioengineer for the same company, BioTech, for the past 10 years. We are currently working on a project that will allow organs produced by 3D printers to be used as transplants instead of donor organs. BioTech just printed the first vascularized kidney suitable for a transplant. We took cells from a patient whose illness is causing his kidneys to shut down and used these cells as the material input for the printer. This patient has been on the top of the transplant list for quite a while, but we have been unable to find a match. The patient only has a few more weeks before his other organs start shutting down. For this reason, we thought he would be an excellent candidate for the first 3D printed organ transplant. The news has been covering this story since the beginning because of not only the revolutionary technology at work, but also because the deathly ill patient is only twelve years old. I am the head of the project committee that created the kidney for this boy. We used cultured cells as the material in the 3D printer, and, because cells are living, we also had to use a specific amount of bioink. Bioink is a gel that contains all of the necessary nutrients and oxygen that the cells need to thrive properly [1]. Without this gel, the cells would not be able to survive the printing process. The machines we used are from Organovo, a company which has been using 3D printers to create different types of tissue ever since the first time cells were successfully used as 3D printer ink in 2003 [2]. We loaded the calculated amount of bioink and cells and printed the kidney for the patient. The 3D printer took the bioink that was loaded into the reservoirs and a 3D computer aided design (CAD) file of the patient’s kidney and was able to generate aa tangible organ from it. The process took about 4 weeks to fabricate the entire kidney, and it was finished just in time. Now, just days before the scheduled transplant, the engineer who calculated the amount of bioink needed to keep the cells at an optimal state has come forward to tell me he made a mistake. When looking at the results again, he realized he hadn’t double checked his calculations, which is the protocol at our company, so he redid the calculations and discovered the amount he calculated the first time was not enough bioink. This means that some of the cells in the newly fabricated kidney could be damaged, dying or mutated due to a lack of oxygen and food. Ultimately, it means that the kidney is not suitable for transplant and we must print a new one. However, the patient might not live long enough to print a new kidney. So, I am faced with a huge decision: do I allow the transplant to go on as planned and possibly save a little boy’s life? Or do I report the incident, restart the process and hope that the patient can hang on long enough to print a new kidney? University of Pittsburgh, Swanson School of Engineering 2014-10-28 1 THE ETHICS OF THE DECISION Ethics guide us to make the best possible decisions in the view of the society. Ethics are important to all lines of work, but especially in engineering. When working with advanced technologies and machines it is important to make a clear set of guidelines because nothing like them have ever been made before; many of the projects engineers work on are unprecedented. The American Society of Civil Engineers wrote in the article “The Importance of Understanding Engineering Ethics,” that learning about ethics is a lot more than just learning a set of guidelines; it’s about understanding how situations test how an engineer adheres to the code in “times of ethical challenge” [3]. This is exactly what my situation is doing; it is testing me to see how well I will follow the principles I am supposed to perform under. When making my decision, there are many different ethical codes I must keep in mind. Working as a bioengineer, there are two separate, yet overlapping, codes of conduct I must abide by. The first is the National Society of Professional Engineers (NSPE) code of conduct. This code of conduct must be followed by any and all types of engineering; it is the blanket code for the general engineers. The second, more specific code of conduct catering towards biomedical engineers is the Biomedical Engineering Society Code of Ethics. This code of ethics involves engineering as it relates to the medical field. For example, the confidentiality rules that doctors follow must also be observed by biomedical engineers. These codes of ethics will aid me in deciding what to do about the 3D printed kidney. NSPE CODE OF ETHICS Cannon 1 Often times, when a set of rules or guidelines is written, the most important or most commonly referred to principle is the first one on the list. The NSPE code of conduct is no exception. In almost every ethical decision engineers make, the first fundamental cannon is referenced. The first cannon reads “engineers shall hold paramount the safety, health and welfare of the public” [4]. In this situation, the general public being referred to means I have to consider how my actions would affect everyone who needs a transplant. By allowing the transplant to take place, I would be undermining the whole system of organ donation. I, also, must think about the safety of the patient. Transplant surgeries put the body under a lot of stress, and at his stage of illness it will be extremely painful. He could go through all of the pain of surgery and still end up deteriorating if the kidney is too damaged. On the other hand, Katie Poduska if the transplant goes smoothly and the calculation error was not significant enough to change anything, then the patient could heal completely. There is no way to know for certain how much of the kidney is damaged, so there is nothing we can do to determine how the patient will respond. stated in the BMES code apply to my situation and will help me reach my decision. Professional Obligations Similar to the first fundamental cannon of the NSPE code, one of the guidelines outlined by the BMES code of ethics reads: biomedical engineers shall “use their knowledge, skills and abilities to enhance the safety, health, and welfare of the public” [6]. As discussed previously, the best decision for the public would be to announce the mistake and start from scratch. This would be the most honest approach and could be better in the long-run; for example, if the transplant is completed and the damage to the kidney is too extensive, it would reflect poorly on 3D printed organs, as well as my company and my team. This patient is just one of many that will have the option of accepting a 3D printed organ. My decision not only affects his life, but the lives of everyone waiting on the organ donation. Another professional obligation listed in the BMES code says that biomedical engineers must “strive by action, example, and influence to increase the competence, prestige, and honor of the biomedical engineering profession” [6]. This also applies to my situation because what I decide could affect the honor of my profession. Choosing to ignore the problem is essentially lying to my peers, and no matter what my reason is, this would not be beneficial in any way. Cannon 5 Another cannon that I must keep in mind is the fifth cannon of the NSPE code of conduct. It states: “engineers shall avoid deceptive acts” [4]. It is clear that if I allow the surgery to take place without revealing what I know I will be deceiving everyone. I will be lying to the patient, the patient’s parents and everyone else keeping track of this case. By not saying anything, I am indirectly claiming that everything went according to plan. In addition, when our work is published and made available to other engineers at the end of this project, there is a very strong possibility that someone else will discover the mistake and point it out. That gives me another decision; if the transplant takes place, I have the option to publish the actual calculations, or I could falsify them so no one knows about the mistake made by my colleague. This would be considered yet another act of deception. The fifth cannon, unlike the first cannon, leans heavily to one option – tell the truth. Knowing this will weigh heavily on my final decision. Profession Obligations Perhaps the most relevant and straightforward part of the NSPE code of conduct relating to my situation is the first professional obligation. It simply states: “engineers shall be guided in all their relations by the highest standards of honesty and integrity” [4]. It then goes into further detail by saying “engineers shall acknowledge their errors and shall not distort or alter the facts” [4]. This quite clearly tells me exactly what I should do. I should tell my supervisor about what happened and restart the process of fabricating a kidney. The only thing stopping me from doing it is the patient’s life being on the line. He has suffered so much already, and we got his hopes up by telling him we would make him a new kidney. Without proof that the kidney is damaged, it will be very difficult to tell a family that they must wait another four weeks while knowing the patient probably won’t make it. However, as stated in the article “Ethical Considerations in Bioengineering Research,” biomedical engineers do not deal with moral and legal issues very often [5]. We instead must separate our emotions from our logic and remain completely objective. This is the part of the decision I am struggling to accept. Health Care Obligations Very few engineers deal with the medical field; therefore, health care obligations are not listed in the NSPE code of conduct. However, they are discussed in the BMES code of ethics. The first health care obligation that must be observed states engineers must “regard responsibility toward and rights of patients, including those of confidentiality and privacy, as their primary concern” [6]. The patient, and, in this case, the patient’s parents have a right to know what happened regarding the kidney. Not sharing this information violates their rights as well as my code of ethics. In my opinion, because the patient is a minor, it is even more crucial to make sure the parents know everything. The patient is deemed too young to make proper, educated decisions about his surgery; he does not have the power to refuse the surgery, therefore, keeping the parents in the dark is taking advantage of this. Research Obligations Printing the kidney had many different steps, all of which have been recorded and published as research after the project is completed. The BMES code of ethics has guidelines involving research that must be followed. Specifically, “biomedical engineers involved in research shall publish and/or present properly credited results of research accurately and clearly” [6]. Publishing the exact results will not be a problem if we start over and fabricate an entirely new kidney, but, if we use the kidney we have, I have another decision to make. Publishing the actual results risks being found out, but altering the research violates the code of ethics. In this aspect, BMES CODE OF ETHICS Because the Biomedical Engineering Society (BMES) Code of Ethics is merely a more specific code than the NSPE code, some of the cannons overlap or say the same thing with an added twist relating it back to biomedical engineering instead of the general engineering public. Many of the ethics 2 Katie Poduska it seems like a better idea to start a new kidney and publish the truth. the lives of many more people in the future. We knew when we started this project that it might not work, but we all had hope. Now the only thing we can do is hope that the patient can hang on for another four weeks. Whenever there is a sticky ethical situation, it often helps to look carefully at the codes of ethics, talk to people about the problem, and write down the pros and cons of each decision; it may be difficult separating emotion from profession, but it is a necessary evil in these types of situations. OTHER SOURCES OF INSIGHT Family After reading through the codes of ethics, I am still not sure about what I should do. So, just like I always do, I turn to my family for help. I called up my mom, explained everything to her, and told her why I was having such a difficult time coming to a conclusion. I told her that the error made in the lab may or may not have a significant impact on how the kidney functions and there is no way to tell for sure. I am letting my emotions cloud my objectivity and we both know it. I do not want a little boy to die due to a simple mistake; especially when we do not even know if it had that big of an impact. However, I do not want to put my integrity and my job on the line either. My mom did not tell me what to do, she instead told me I am ultimately the only one who can make this decision and she cannot do it for me. She told me she would support me no matter what I decide regardless of what happens as a result of my decision [7]. At the end of my conversation with my mom, I feel a lot more sure of myself and what I am going to do, but I am still a little hesitate. The only thing I know for certain was that I am very fortunate to have people in my life who support me the way my family does. REFERENCES [1] W. Harris. (2013). “How 3-D Printing Works.” How Stuff Works. (Online Article). http://health.howstuffworks.com/medicine/moderntechnology/3-d-bioprinting3.htm [2] Organovo.com [3] “The Importance of Understanding Engineering Ethics.” (2012). American Society of Civil Engineers. (Online Article). http://www.asce.org/Ethics/A-Question-ofEthics/2012/May-2012/ [4] “NSPE Code of Ethics for Engineers.” (2007). National Society of Professional Engineers. (Online Article). http://www.nspe.org/resources/ethics/code-ethics [5] N. Naurato, T.J. Smith. (2003). “Ethical Considerations in Bioengineering Research.” National Institute of Health. (Online Article). http://www.ncbi.nlm.nih.gov/pubmed/12724954 [6] “Biomedical Engineering Society Code of Ethics.” (2004). Biomedical Engineering Society. (Online Article). http://bmes.org/files/2004%20Approved%20%20Code%20o f%20Ethics%282%29.pdf [7] L. Poduska. (2030, Aug. 16). Conversation. Baltimore Marina Now that I have talked to my family and looked through all of the codes of ethics, there is only one thing left for me to do: make a decision. Whenever I have a lot to think about, there is one place that I go to, and that’s the Baltimore Marina. Luckily, my favorite time to go is in the fall on days like this. I go and sit on a bench on top of a hill that overlooks all of the boats and the ocean. When I was growing up, I was a swimmer. I love the water and the beach. My best friend always invited me to her boat in Sandusky, Ohio in the summer and we would sit on the dock and talk for hours. To this day I think of marinas as a peaceful place to think or talk. It also allowed me to see the hospital, so I could focus my thoughts more easily. I sat there listening to the water as it splashed the rocks and watched as the boats bobbed gently with the waves. I thought about everything I had been worrying about and everything my mom told me. As the sun started setting, I realize I had been sitting in the same spot for almost two hours. That’s when I knew it was time to make a decision. Reflecting on the code of conduct and the code of ethics, I can see that the clear choice was to start over and reprint the kidney. I cannot let my emotions get in my way. Almost every cannon in the codes of ethics points to starting over, no matter how difficult telling the truth will be. The patient may only be twelve which makes this decision a hard one to accept, but, even if my decision results in his death, it will still allow biomedical engineers to advance 3D printed organs to save ADDITIONAL SOURCES “Ethics Case Studies in Biodesign.” Stanford. (Online Article). http://biodesign.stanford.edu/bdn/resources/ethicscases.jsp “Cases and Scenarios.” Online Ethics. (Online Article). http://www.onlineethics.org/Resources/Cases.aspx “Ethics Case Studies.” WebGuru. (Online Article). http://www.webguru.neu.edu/professionalism/researchintegrity/ethics-case-studies ACKNOWLEDGEMENTS I would like to thank my family for always being there for me and supporting me as I take on all my dragons. I would also like to thank Jessica Klitsch, Sarah Painter and Robyn Moyer for putting up with me. 3