Budny 10:00 L16 ETHICS APPLIED TO INTRACAVITARY BALLOON CATHETER BRACHYTHERAPY Anna Dzuricky (atd21@pitt.edu) barrier, accurately emits radiation to a specific area of the brain to minimize excessive/ harmful radiation, and is easily implanted post surgery. This brachytherapy system is marketed exclusively by GliaSite, in the United States [4]. The success and public availability of this type of brachytherapy could lead to increased life spans and possible elimination of the cancer from the body. Plus, this device could lead to other advancements in cancer radiation treatments for numerous other organs, reducing the influence of one of the leading causes of disease and death in our world. My team was assessing the effectiveness of not specifically the GliaSite balloon catheter, but rather the radioactive isotope injected into the balloon as part of the chemotherapy process. Previously, IsoRay had used the liquid radioisotope known as Lotrex (Iodine-125) [5]. Our team found that another radioisotope was far superior to the existing Lotrex in terms of effectiveness of radiation as applied to the GliaSite intracavitary balloon catheterization. This new isotope was liquid Cesium-131, named Cesitrex [6]. We concluded that Cesitrex eliminated the need for a thyroid block as required with Lotrex, was safer with patients and staff, and easier to clean up than other isotopes [6]. Cesitrex has very similar energy to Lotrex, thereby not compromising the strength of radiation. Cesitrex had a far shorter half-life, consequentially making patients with Cesitrex treatment, radioactive for only 30 days, as opposed to the 180 days experienced by patients with the Lotrex treatment [7]. These results were so exciting that IsoRay had promptly filed for a FDA approval of the radioisotope. Because the project involved significant intellectual property, everyone on the team was required to sign a confidentiality agreement. Nearing the end of the summer, I overheard one member of my team speaking to a former colleague working for a different corporation about our new technology. My team member explained our entire summers-worth of research to his friend. I was concerned about the legal repercussion bound for my team member for breaking the confidentiality contract, as well as for the credibility of the research done by my entire team, including myself. INTRODUCTION Ethics in the field of engineering focuses mainly on one specific form of ethics known as normative ethics. Metaethics (how our ethical standards arise) and Applied ethics (focused on specific issues) both are important forms of ethics, but they are only subsequently analyzed in engineering, as they relate to normative ethics [1]. As defined by George D. Catalano in his 2006 publication Engineering Ethics: Peace, Justice, and the Earth, “Normative ethics seek to provide standards that can govern right and wrong behavior” [1]. The Golden Rule is an example of a moral standard such as this [2]. The most significant assumption made in normative ethics is that there is only one ultimate criterion of moral conduct, whether it is a single rule or a set of principles. There are three variations in normative ethics. These variations include virtue, duty, and consequentialist theories. Virtue ethics place less emphasis on learning rules, but rather stress the significance of developing good habits of character [3]. Duty ethics base morality on specific, basic principles of obligation. They are often associated with ideologies such as fidelity, reparation, gratitude, justice, etc… [1]. Lastly, Consequential ethics involve the weighing of the pros and cons in an ethical situation in order to determine whether the total good consequences outweigh the total bad consequences [3]. One form of Consequential ethics, Utilitarianism, is especially influential in the engineering world. Utilitarianism is based on the assumption that, “an action is morally right if the consequences of the action are more favorable than unfavorable to everyone” [1]. In a broad sense, Utilitarianism defines the unspoken yet largely significant mission of working as an engineer – to perform an action where the consequences are favorable to all. In simpler words, utilitarianism means working for the improvement of all peoples’ lives. Therefore, the importance of ethics in engineering cannot be understated due to the overwhelming fact that engineering ethics are integrated and help define essentially the work of all engineers. SUMMARY AND EVALUATION OF AVAILABLE SOURCES ETHICAL DILEMMA This past summer, I was working in a lab with a team on a research project involving various radioactive isotopes for the application of chemotherapy via intracavitary balloon catheters for IsoRay Inc. Intracavitary balloon catheter brachytherapy is currently the most suitable choice for radiation therapy after resection of a brain tumor. This type of drug delivery has the ability to bypass the blood brain University of Pittsburgh, Swanson School of Engineering 2014-10-28 In my assessment of the sources available to me as I was dealing with this ethical decision, I found multiple sources that were both helpful, and likewise inadequate. These sources included engineering codes of ethics, various case studies, and two additional sources. 1 Anna Dzuricky Violations [10]. This case dealt with financial constraints, and fire safety and public health. In the case, a client lost funding for renovations that would result in the building passing local fire codes [10]. The main connections I saw between my case and this fire safety case revolved around the issues of revealing information without prior consent of the client or employer, and the disclosure, without consent, of confidential information concerning the business affairs or technical processes of a client or employer. In the case, the engineer working with the client would be forced to break his confidentiality agreement if safety was being questioned. Reading the case study was very useful because it clarified that the only condition under which an engineer would break confidentiality would be for the sake of safety. The case study did concern safety of people, and the engineering authority was notified. The case study utilized the points under the National Society of Professional Engineers, but further explained them and presented them in relation to actual examples of where the points were applicable. From the case study, I could conclude that because there was no question of safety in my ethical dilemma, that my team member had been ethically wrong in breaking confidentiality. The proposed action by this case study would be to notify the leader of the team so that they could take appropriate measures. The next case study that I researched was Case 7 – A Problem of Understanding from Stanford Biodesign [11]. This case dealt with the possibility of using others’ work to publish/ patent something of your own. Specifically in this case, a young inventor was refusing to take suggestions from a fellow engineer who had better resources in order to ensure that the significant discovery was widely and more readily made available [11]. Connections between this case study and my own situation could be seen in taking others’ work and presenting it as your own. Under any circumstances, this action would be considered plagiarism or theft, and is highly prohibited, as was seen in both codes of ethics that I researched. I found fewer benefits from this case study, simply because I was previously aware of the fact that plagiarism is not tolerated in engineering (and practically in any other discipline). The case clarified that point. Therefore, I concluded that my team member’s breach of confidentiality that quite probably could have led to plagiarism (on the behalf of his friend) was unethical. The last case study I studied was Case 7 – Sometimes Silence is Golden from WebGURU [12]. This case outlined a situation where a man working on a team researching a new technology witnessed another member of his team who had signed a waiver of confidentially; speak about the technology to another man from another research group [12]. Essentially, this case study aligns perfectly with the ethical dilemma presented to me in the IsoRay lab. In this case study, I learned that because everyone in the group signed a confidentiality agreement, there were laws that applied to the Engineering Code of Ethics The first source I explored in pursuit of some advice was the National Society of Professional Engineers Code of Ethics for Engineers [8]. The parts of the code that concerned my ethical debate were specifically sections I, II.1.c., III.4., and III.9.. Section I: Fundamental Canons explained the basic ethical code for professional engineers. The most significant points made here were, “3. Issue public statements only in an objective and truthful manner. 4. Act for each employer or client as faithful agents or trustees. 5. Avoid deceptive acts. 6. Conduct themselves honorably, responsibly, ethically, and lawfully so as to enhance the honor, reputation, and usefulness of the profession” [8]. Despite these key points being presented in a way that was easily understood, they were very little help because of their vagueness. Section II.1.c stated, “Engineers shall not reveal facts, data, or information without the prior consent of the client or employer except as authorized or required by law or this Code” [8]. This point was more specific, yet still did not assist me in my ethical dilemma. Section III.4 deals with not disclosing information to anyone who an employer has not approved. Section III.9 deals with giving credit to whom credit is due, and recognizing the proprietary interests of others. In general, the National Society of Professional Engineers Code of Ethics was not a very useful resource for my situation because the document was aimed at informing engineers on how to conduct themselves ethically, but not on how to deal with specific situations such as mine. The second source I researched was the Biomedical Engineering Society Code of Ethics [9]. This code of ethics was even more general than the National Society of Professional Engineers Code of Ethics. For example, the BME Code expresses verbal integrity by, “Publish and/or present properly credited results of research accurately and clearly” [9]. Similar to the previous studied code, this code of ethics states general key points on engineering ethics. However, these points are presented in an informative manner rather than a way in which engineers like myself can interpret them to real-life situations. Overall, the codes of ethics that were researched were not very helpful because of their vagueness and simplicity, as well as their presentation. If I were an amateur engineer who wanted to be made aware of universal codes of ethics for all engineers, these two sources would be very effective. However, the key points were not given in an applicable manner to current engineering ethical dilemmas such as the one I was presented with in the IsoRay lab, working on radioisotopes for the intracavitary balloon catheter. Case Studies The first case study that was researched was from the National Society of Professional Engineers, Case No. 13-11 – Public Health and Safety – Delay in Addressing Fire Code 2 Anna Dzuricky breaking of that contract due to its legal nature [12]. Breaking that legal contract would result in legal prosecution by the funder (in my case, IsoRay), should they choose to take legal action. This case study was very useful because of how directly it related to my specific situation. I discovered the legal implications that were referred to briefly in my research of the code of ethics. Therefore, it was suggested that our employer, IsoRay, would legally prosecute my team member for his breaking of the confidentiality agreement, if authorities were notified of my team member’s actions. other engineers faced with ethical dilemmas, I would suggest looking at both the codes of ethics for engineers as well as multiple case studies. Consulting additional sources and evaluating personal ethics also are useful in coming to a final decision about an ethical dilemma. In my ethical engineering dilemma, I witnessed a team member break a confidentiality agreement that all team members signed, and possibly aid another colleague in the stealing of original ideas regarding the more-effective Cesitrex treatment for a GliaSite intracavitary balloon catheter, while working for IsoRay. The codes of engineering ethics were very basic in nature, and sometimes were too vague to apply to realistic situations. However, their application in conjunction with multiple case studies provided much insight into what others had done in similar situations. Lastly, the additional sources of my brother and ethics teacher, gave me an extra sense of what other people (sometimes not engineers) would do in my situation, while reminding me to include some of my own personal ethics in my decision. In general, I found that the codes of ethics, case studies, and additional sources all suggested notifying a higher authority so that they could take further action regarding legal prosecution and punishment for possible plagiarism. Therefore, in a utilitarianistic frame of mind, I concluded that I would notify my supervisor of exactly what I had overheard/ witnessed because I believed, and was supported by the National Society of Professional Engineers and BME Codes of Ethics, as well as the case studies and additional sources that what I had witnessed was ethically wrong. Additional Sources In addition to my research done in both the National Society of Professional Engineers and BME Code of Ethics, and well as the three case studies, I also employed the use of two resources I have utilized before in ethical decisionmaking. The first additional source I consulted was my brother, Michael Dzuricky [13]. Not only is he a trusted, truthful friend, but he also is a biomedical engineering graduate student at Duke University. Upon asking him what action I should take, as a witness to an ethical dilemma with multiple consequences, he told me that if I felt that there was an ethical code broken, that I should notify the supervisor of the lab team and let him handle the rest [13]. I thought this was useful advice, especially because it had been what he had done in a similar situation with his lab in undergraduate college. The second additional source that I utilized was my high school ethics teacher, Matthew Ochalek [14]. When asked the same question that I had related to my brother, Mr. Ochalek stated that because I was fully, consciously aware of the situation in which my team member knowingly broke his confidentiality agreement, I had a moral obligation to myself to do what I believed was right [14]. This information was new, considering that in the profession of engineering, my decisions affect not only me, but also large numbers of people. Personal morals play a role in my particular situation, as they would with any ethical decision, however because the context of the ethical dilemma is engineering, ethical decisions must be based on some sort of engineering-ethical basis, and not solely on personal ethics. However, Mr. Ochalek’s insight was still useful in reminding myself to factor in my own personal ethics, in addition to the engineering ethics that I had researched. REFERENCES [1] G. Catalano. (2006). Engineering Ethics: Peace, Justice, and the Earth. New York: Morgan & Claypool. (print book). pp. 13-17 [2] J. Wattles. (December 1996). The Golden Rule. Oxford: Oxford University Press. (print book). pp. 167 [3] T. Holt. (2009). “Normative Ethics.” Moral Philosophy. (website). http://moralphilosophy.info/normative-ethics/ [4] (8 July 2014). “Intracavitary Balloon Catheter Brain Brachytherapy for Malignant Gliomas of Metastasis to the Brain.” BlueCross BlueShield of Mississippi. (website). http://www.bcbsms.com/index.php?q=medical-policysearchpage.html&action=viewPolicy&path=%2Fpolicy%2Femed %2FIntracavitary+Balloon+Catheter+Brain+Brachytherapy+ for+Malignant+Gliomas+or+Metastasis+to+the+Brain.html [5] W. Stomp. (13 September 2011). “IsoRay Receives FDA Clearance for GliaSite Brachytherapy Balloon Catheter for Brain Cancer.” MedGadget. (online article). http://www.medgadget.com/2011/09/isoray-receives-fdaclearance-for-gliasite-brachytherapy-balloon-catheter-forbrain-cancer.html CONCLUSION Utilitarianism can be classified as the foundation for all engineering ethical concepts. Consequences that result in what is best for all, is truly what I believe engineering to be, at its most basic function. Therefore, combining ethical values as a community of engineers and personal morals is essential to all decisions made in the engineering world. For 3 Anna Dzuricky [6] (12 May 2014). “IsoRay’s Liquid Cesium-131 (Cesitrex) Receives Final Regulatory Approval for Use in GliaSite Brain Cancer Treatment System.” IsoRay. (online article). http://www.isoray.com/custom_type/isorays-liquid-cesium131-cesitrex-receives-final-regulatory-approval-use-gliasitebrain-cancer-treatment-system/ [7] (17 October 2013). “Cesium-131 Seed Brachytherapy Plus Subtotal Resection for Lung Cancer Patients.” National Cancer Institute. (website). http://www.cancer.gov/clinicaltrials/search/view?cdrid=744 482&version=HealthProfessional [8] (July 2007). “Code of Ethics for Engineers.” National Society of Professional Engineers. (online article). http://www.nspe.org/sites/default/files/resources/pdfs/Ethics/ CodeofEthics/Code-2007-July.pdf [9] (February 2004). “Biomedical Engineering Society Code of Ethics.” Biomedical Engineering Society. (online article). http://bmes.org/files/2004%20Approved%20%20Code%20o f%20Ethics(2).pdf [10] (30 April 2014). “Public Health and Safety-Delay in Addressing Fire Code Violations.” National Society of Professional Engineers. (online article). http://www.nspe.org/sites/default/files/BER%20Case%20No %2013-11-FINAL.pdf [11] “Case 7-A Problem of Understanding.” Stanford Biodesign. (website). http://biodesign.stanford.edu/bdn/ethicscases/7problemofund erstanding.jsp [12] “Sometimes Silence is Golden.” webGURU. (website). http://www.webguru.neu.edu/professionalism/casestudies/sometimes-silence-golden [13] M. Dzuricky. (25 October 2014). Interview [14] M. Ochalek. (25 October 2014). Interview ACKNOWLEDGEMENTS In the writing of this paper, I would like to acknowledge my constant roles models (my grandma and papa) for continuing to inspire me. In particular I would like to acknowledge my brother and Matthew Ochalek for their sagacity and help with this assignment. Plus, I would like to thank my family and friends for all they have done and continue to do for me as I continue my education in engineering. 4