ENGR 0011, Bursic, 2:00 PM R07 SHARING UMBILICAL CORD TISSUE UNITS FOR COMPENSATION: A CASE STUDY IN THE ETHICAL ENGINEERING DECISION MAKING PROCESS Taylor Jones (tgj7@pitt.edu) THE SITUATION: HOW I ENDED UP WITH AN ETHICAL DILEMMA I was doing research with the University of Kansas Medical Center on umbilical cord tissue mesenchymal stem cells and working part time for the National Institute of Health in the summer of 2012. The institute was knowledgeable of my research position at the university as it occasionally affected my work, especially if I had to travel or attend conferences. At the University, we were making great strides towards the “isolation of the Wharton's jelly matrix to be used as a scaffold for tissue regenerative applications” [1]. We were specifically looking at the use of the stem cells in this matrix as a way to treat avascular necrosis, a bone disease that causes eventual deterioration of the bone tissue [2]. The study solicited umbilical cord donations from the general public with the conditions that the participants must be pregnant females over the age of 18 who are willing to donate [1]. When donating umbilical cord tissue for stem cell research, the tissue must be collected at the time of birth and stored properly soon after [3]. The stem cells in the tissue have the potential to treat and cure a wide variety of diseases including those of the cartilage, bone, heart, and spinal cord [3] and are therefore highly sought after in research. The University of Kansas received an influx of participants, far more than it could use for the study due to limited resources, so we ended up with an excess of umbilical cord units. At the same time, the National Institute of Health was researching in the same field, but with more varied applications in the treatment of diseases. The institute has a highly specific process of obtaining and processing umbilical cord units for research, which does not allow for donations from the general public [4]. Due to this process, there was a lack of cells to perform research with, and the NIH was falling behind in publishing its findings. For this reason, the chair of stem cell research at the Institute approached me about obtaining ten units of umbilical cord donations from the University of Kansas. He offered a large stipend for my efforts as well. INTRODUCTION: THE ETHICAL CONCERNS AND DECISION MAKING RESOURCES University of Pittsburgh, Swanson School of Engineering 2013-10-29 1 I was now faced with several dilemmas. By not giving the Institute more units, I could be limiting the field of research and halting any new findings that could save hundreds of lives. In the same breath, if I gave the Institute the units, I would be going against its policy of not accepting donations from the general public, which could negatively affect the research process. And lastly, I debated whether it would be okay to take from one of my employers and give to another, with a monetary benefit to myself. When deciding how to deal with these ethically charged questions, I spent a lot of time consulting engineering codes of ethics including those of the National Society of Professional Engineers and the Biomedical Engineering Society. I also consulted several resources on morals and social impact in engineering situations. I made a list of all the pros and cons to any possible decision and consulted with family and friends to obtain their opinions. AN APPLICATION OF THE BMES CODE OF ETHICS Upon consultation with the Biomedical Engineering Society’s Code of Ethics, a highly regarded document among biomedical engineers, I was able to determine some potential deciding factors in my decision making process. The first section, Biomedical Engineering Professional Obligations, highlighted the idea of helping others, but at the same time, respecting and upholding the honor of all biomedical engineers [5]. I found that giving the excess units of umbilical cord tissue would be helpful to the general public because it would increase the speed at which new discoveries could be made and brought into medical practice. But then, by secretly giving these units to the NIH I am not only putting my reputation at risk, but also an entire society of biomedical engineers, negatively impacting the way the public looks upon us and possibly halting any further recognition or willingness of others to participate in biomedical engineering studies. Giving the units to the NIH without the permission of the University of Kansas also violates the standards set forth in the Research Obligations of Biomedical Engineers. These standards clearly state the need to give proper credit to all involved in the research [5], so if the university put forth the effort to obtain these units, they should be cited as doing so, bringing up another issue. The National Institute on Health has a guideline that limits the participant pool for umbilical cord donations; it cannot use units from the general public. By giving the institute the excess units from the university, I Taylor Jones am allowing those involved to go against company policy. It is my responsibility to step in and protect the institute, the larger society of biomedical engineers, and any potential patients to whom the research is applied. There is also an issue with donor rights, which is stated to be a primary concern in the Health Care Obligations Code [5]. The donors have a right to know where their umbilical cord units will be used and what they will be used for. If they only signed consent for use at the University of Kansas with certain parameters, then that’s the only way their donations can be used. I determined that all of the ethical standards presented in the Biomedical Engineering Society’s code applied to my scenario, with the exception of those about training obligations. My situation did not involve any student training, so there was no need to worry whether special interests would be involved. Although the code did give me a lot to think about, it provided a more conflicting view than I would have liked, so I had to weigh out which codes were more important and relevant to my situation than others. entire society of people at risk of scrutiny and could limit future funding and participation in engineering research. This possibility not only violates this code, but would also limit the ability of engineers to help the public, a fundamental principle of our existence. In addition, the secretive nature of the process would not allow for proper credit to be given to the University of Kansas for their effort in soliciting participants and obtaining the umbilical cord units. Because of the scope of my scenario, I was able to disregard quite a few irrelevant cannons and principles, but the majority could be applied and evaluated in this context. Most of the disregarded ideas were about special interest, which did not play a key role in my situation. Overall this source was very useful it pointing out which of the Biomedical Engineering standards I should hold with the highest regard. It also gave me an idea of how many codes I could potentially violate by giving the units to the NIH. CORD BLOOD BANKING ARTICLE: MAINTAINING INFORMED CONSENT AN APPLICATION OF THE NSPE CODE OF ETHICS Upon further research, I discovered an article by Cathy A. Cooper and Mariesa R. Severson entitled Cord blood and tissue banking: supporting expectant parent's decision making. This article emerged from the International Journal if Childbirth Education and discussed the need for doctors and medical professional to provide the facts about umbilical cord banking so that parents were able to make informed decisions [7]. I deemed the facts presented in this article important due to their international recognition and specificity to my situation. The authors were concerned that families were not being properly notified of all components of the donation/banking process. Although this article was presented based on public and private cord blood banking, the premise of informed consent was important to my situation. I learned from another source, that informed consent should include a section on the disclosure of information [8] about the participant and their donation. Reading this article made me think further about how donating excess umbilical cord units would affect the study participants. I realized that some parents might be okay with donating to the research at the University of Kansas, but not to the research at the NIH. For example, maybe they did not agree with some of the NIH’s research practices and would not want to contribute to such a cause. The participants also have a right to privacy that is being violated through the sharing of these units. The units that people so graciously donate are what allow further research in engineering; disrespecting or possibly upsetting patients will limit the number of people who want to participate in future studies. Several of the cannons in the National Society of Professional Engineers Code of Ethics underlined the same ideas that the BMES code underlined, allowing me to determine which codes I should hold with higher importance. This source also applies to the entire engineering field and states the minimum expected of one who works in such a field. I was also able to gather some new ideas of what should influence my decision. For example, rules of practice, cannon one, subsection d, e, and f, states that engineers should not become involved with businesses that are conducting dishonest practices [6]. Instead of simply, not giving the umbilical cord units, this standard requires that I completely dissociate from the NIH and then report them to the proper authorities. This standard will rank higher in my decision making process because of the severity it suggests. Cannon four of the same code of ethics relates to compensation for work in a study or research program. Engineers cannot accept compensation from an outside source for the work they are doing at a university, hospital, or any other research institution [6]. It is deemed unethical for me to accept payment at the University of Kansas and them provide services to the NIH that stem from my research at the University for any type of payment. The decision to give the excess umbilical cord units would also violate several professional obligations outlined in the NSPE code of ethics. Section e of the first subheading related to acting with honesty and integrity states “engineers should not promote their own interest at the expense of the dignity and integrity of the profession” [6]. Accepting money form the NIH would benefit me, but could put an ENGINEERING ETHICS OPINION: EVERYONE’S RESPONSIBLE 2 Taylor Jones faced with an ethically charged decision. For this reason I find it very helpful to sit down and write out a pro and con chart for each outcome and then weigh each pro/con in order to find the overall benefit or detriment of that decision. This strategy also helps me to compile all the research I have completed and organize it such a way that is clear and that I can return to several times to think about. From the ethical codes alone, I accumulated several reasons to accept or deny the request for umbilical cord units from the National Institute of Health and a chart helps me to find where the codes overlap and reveals reoccurring themes, which can then be valued with greater significance. Then, I am also able to add new information to it. For example, when I talked to my mom about what she thought was best, I was writing notes on my pro/con chart. The visual representation helps me to ultimately make my decision. The professional journal article by Josep M. Basart and Montse Serra entitled Engineering Ethics Beyond Engineers’ Ethics presented in the Science and Engineering Ethics Journal expanded the way I was thinking about engineering ethics. I was able to accept the authors’ ideas because many of the engineers’ ethics that they discussed connected to the NSPE and BMES codes of ethics. The authors made a good point that the ethics of engineering are not just about how one person acts, but how the entire engineering community and all involved should act [9]. They recognized that everyone involved in an engineering situation in responsible for the ethics of each other and the process [9]. This idea made me think about all of the ethical codes and standards that the chairman was violating by offering me money for the umbilical cord units. I realized that by accepting the offer, I would be going against ethical engineering practices and I would be allowing the chairman to do the same. I was just as responsible as he was and I had to step in to stop the progress of unethical events. CONCLUSION: ACCEPTING THE OFFER WOULD BE HIGHLY UNETHICAL Upon evaluation of all the sources stated above, I would decide not to give the excess umbilical cord units to the National Institute of Health. Accepting the money and giving away the umbilical cord units violated far too many ethical principles presented by both the Biomedical Engineering Society and the National Society of Professional Engineers. I realized that ethical engineering is not a personal endeavor. Everyone involved in the research is responsible and everyone will suffer the consequences. I had to step in and protect the greater engineering society. In addition, any advancement in NIH research would have to be revaluated or ignored, nullifying the one key benefit of transferring the units. Weighing out all of the pros and cons of my decisions and thinking about the research I had done ultimately helped me to choose the more ethical option. SPEAKING WITH FAMILY AND CLOSE FRIENDS: GAINING AN UNBAISED OPINION Speaking to others when I am having trouble making a decision not only provides me with new ideas and opinions from others, but also helps me think through the situation. I often find that when I talk to others about a topic or question, I think about new aspects of the situation. A conversation also provides an opportunity to offer an idea and have it critiqued by someone outside of the immediate situation. When choosing someone to talk to, it is important to have a variety of people and a least one who will offer a complete outside perspective. This unbiased opinion of a past professor or current coworkers, for example, will be very valuable because they do not have any emotional connections. At the same time it is also important for me to talk to someone I confide in. I will be more likely to share information and internal conflicts I have if I talk to my mom, dad, or sister. In this scenario, while the conversations were occurring, I took copious notes that way I could return to them later with a clear mind and reflect. From these conversations, I would be able to accumulate an idea of what others would perceive as right and wrong, giving me a glimpse into how outsiders would view my decision. REFERENCES [1] O. Aljitawi. (2010, July 19). “A Research Study Looking at Specific Tissue of the Umbilical Cord.” ClinicalTrials.gov. (Online Study Record). http://clinicaltrials.gov/show/NCT01166776 [2] “Avascular Necrosis.” (2013). Cleveland Clinic. (Website). http://my.clevelandclinic.org/orthopaedicsrheumatology/diseases-conditions/hic-avascularnecrosis.aspx [3] “What is Cord Tissue?” (2013). Americord. (Website). http://cordadvantage.com/cord-tissue-banking.html [4] “Stem Cell Information.” (2013). National Intitues of Health. (Website). http://stemcells.nih.gov/info/pages/faqs.aspx#umbilical [5] “BMES Code of Ethics” (2004). Biomedical Engineering Society. (Online). MAKING A LIST OF PROS AND CONS: A VISUAL REPRESENTATION OF THE DECISION MAKING PROCESS I feel that it is very important to take a lot of time to evaluate all possible outcomes and their implications when 3 Taylor Jones [9] J.M. Basart, M. Serra. (2011). “Engineering Ethics Beyond Engineers’ Ethics.” Science and Engineering Ethics. (Online Article). DOI: 10.1007/s11948-011-9293-z. http://bmes.org/files/2004%20Approved%20%20Code%20o f%20Ethics(2).pdf [6] “NSPE Code of Ethics” (2007). National Society of Professional Engineers. (Online). http://www.nspe.org/Ethics/CodeofEthics/index.html [7] C.A. Cooper, M.R. Severson. (2013). “Cord blood and tissue banking: supporting expectant parent's decision making.” International Journal of Childbirth Education. (Online Article). http://go.galegroup.com/ps/i.do?id=GALE%7CA334177957 &v=2.1&u=upitt_main&it=r&p=AONE&sw=w&asid=27f4 bb1c08999f075eb3f8d66be146f9 [8] C. Petrini. (2010). “Umbilical cord blood collection, storage and use: ethical issues.” Blood Transfusion. (Online Article). DOI: 10.2450/2010.0152-09 ACKNOWLEDGEMENTS I would first like to thank all of the engineering 11 writing instructors for their help throughout this writing process. They were always there to answer questions and sent several clarification emails with ideas on how to set up the assignment. I would also like to thank Sam Pittman of the writing center for going through my paper with me and ensuring I aptly described how and why each of the resources were useful. 4