Schaub 6:00 L15 THE ETHICAL DILEMMA OF VARYING LEVELS OF BRAIN-MACHINE INTERFACE INVASIVENESS Max Baxter (mab471@pitt.edu) BRAIN-MACHINE INTERFACES AND THE ETHICAL ISSUE AT HAND Brain-machine interfaces (BMIs) have been vital in treating neurological disorders in recent years, such as paralysis, and are proving to be an extremely beneficial neuroprosthetic [7]. BMIs are interfaces containing a series of electrodes that establish a direct line of communication between the brain and an external computing device. When implementing a BMI, one must determine the level of invasiveness that will be utilized; BMIs are typically grouped into two categories regarding invasiveness: invasive and noninvasive [7]. However, there are several different “levels” within the patient’s head where the interface can be placed at [7]. An ethical quandary thusly arises when considering each level of invasiveness’s multitude of pros and cons. The National Society of Professional Engineers’ (NSPE) and the Biomedical Engineering Society’s (BMES) Code of Ethics aid in determining which approach is ideal, but still leave a lot of room for question. There are a myriad of positive and negative aspects to both the invasive and noninvasive models of the BMI. The noninvasive interface model applies the electrodes directly to the scalp. This means that there is no risk of error in the installment [5]. The typical noninvasive process is called electroencephalography (EEG), which is a means of monitoring electrical activity within the neurons of the brain [5]. The main drawback of the noninvasive approach is that the brain activity cannot be read as easily since the skull can distort the signals [5]. Other drawbacks include the following: “sensitivity to electromagnetic radiation, difficulty to place and position, varying conductance, usually a limited number of channels, and discomfort when used for a longer time.” [5]. However, the noninvasive approach of the EEG is a more portable and cost effective device [5]. The invasive approach to the brain-machine interface has a similar ratio of benefits and drawbacks, and involves surgically placing the electrodes of the interface inside the patient’s head [6]. The invasive approach of the BMI can be viewed as more practical for an individual to utilize in everyday life due to the fact that they are not wired [2]. The invasive method also allows for better extraction of information and signals due to close proximity to the brain; however, there are several health risk factors that arise from any neurosurgical device implantation [6]. The invasive and noninvasive BMI have their respective pros and cons, and the ultimate decision of which method should be used should be determined with consideration of the patient and the benefit to risk ratio of each specific case. University of Pittsburgh, Swanson School of Engineering 2015-10-26 As a neural engineer, a dilemma regarding which level of invasiveness should be used arose when treating a paralyzed and mildly cognitively impaired patient; it was necessary to use a brain-machine interface. The patient in question, Patient A, is an adult of age twenty-seven, and consequently holds full responsibility to determining what treatment, if any, will be utilized [4]. In most situations when treating patients with brain-machine interfaces in the past, I would simply explain the risk factors and potential benefits of both the invasive and noninvasive methods. However the ability of Patient A to make an informed decision due to cognitive limitations raises the ethical question of whether or not they have the ability to make this decision. Patient A is able to communicate through speech, but has difficulty processing information and certain concepts, often demonstrating a limited understanding. Therefore, it is questionable that Patient A can understand the pros and cons of different levels of invasiveness with BMIs, and subsequently make an informed decision about his situation. Patient A stated that he would like the most invasive BMI possible as he would like to maximize his potential benefits despite the risk. I, however, am uncertain if I agree with this decision when considering all of the factors. There is no defined minimum level of cognitive ability that delineates whether or not a patient has the appropriate amount of mental capacity to make an informed decision. The primary issue then arises when considering if I, as a neural engineer, can make the decision of what level of invasiveness should be used. It is imperative to determine whether or not I should favor the benefit to risk ratio of each method or the will of Patient A. While I am confident in my decision making skills regarding Patient A’s situation, the Code of Ethics for both the National Society of Professional Engineers (NSPE) and the Biomedical Engineering Society (BMES) can prohibit my decision making ability based on individual interpretation [1][4]. CONSIDERING THE CODE OF ETHICS The Code of Ethics for the NSPE is key to making the appropriate decision in this particular BMI dilemma. While personal interpretation of the codes is a factor, they still provide clarification towards determining the ideal approach. One professional obligation stated in the NSPE Code of Ethics directly applies to the safety of Patient A: “Engineers shall advise their clients or employees when they believe a project will not be successful.” [1]. This statement gives the engineer more influence in the final decision as the engineer should advise the client on what is considered to be the most Max Baxter successful “project” (where each project has a different degree of invasiveness). The Code of Ethics also states that engineers are not to be influenced by any “conflicting interests” when making a profession decision [1]. The conflicting interests that should be avoided can be interpreted to include the opinions of the patient and his family since both are not experts with this particular innovation. Therefore the patient’s opinion on which level of invasiveness should be utilized should not be a factor in the final verdict based on this section of the code. The engineer’s influence is especially important and should be considered to a perhaps even greater extent due to the fact that this decision may end up being a life or death decision. The BMES Code of Ethics is also a paramount resource that needs to be considered when making this decision. One particular section of the code concerns one of the most important responsibilities of a biomedical engineer: “[Biomedical engineers involved in health care activities shall] regard responsibility toward and rights of patients… as their primary concern.” [4]. This particular statement provides reason for choosing the safest implementation of the interface; the overall health and well-being of the patient is what is most important. This means that any risk for the patient should be reduced even if it means a potentially less effective result. The BMES Code of Ethics also states that the larger consequences of a biomedical engineer’s work must be considered [4]. This also provides reason for choosing the safest approach for the brain-machine interface since the loss of a life is a very large potential consequence that should be avoided. Based on this statement in the BMES code of ethics, it is not worth the risk of a patient death, especially since Patient A is not in potentially fatal trouble in his current situation. Statements in the Code of Ethics for both the NSPE and BMES provide different reasoning for different approaches regarding this particular ethical dilemma. Overall, it seems that the BMES Code of Ethics generally promotes more consideration for the patient in comparison to the NSPE code [1] [3]. The BMES code tends to favor keeping the patient’s safety as the primary concern, which means that any risk should be eliminated [3]. On the other hand, the NSPE advocates for the empowerment of the engineer’s opinion as it recognizes that engineers are the most well informed individuals when deciding when and to what extent a particular innovation should be applied [1]. The Code of Ethics for each society is somewhat useful when deciding which level of invasiveness is the most practical and to what extent an engineer would be able to override a patient’s decision if necessary due to lack of cognitive ability; however, the statements of both codes are contradictory in multiple instances. When faced with an ethical dilemma, the Code of Ethics for both the NSPE and BMES significantly assist in reaching a decision. APPLYING OUTSIDE SOURCES TO THE DILEMMA During various ethical dilemmas throughout my life, I have turned to various outside sources for guidance. My father has always been a prominent figure in my life, and a lot of the morals and ethics that I practice resulted from his leadership. Since he has been extremely significant in defining who I am today, I often call or visit him when faced with a tough life challenge. Even if I do not receive a direct answer regarding what I should do in the dilemma, simply talking out my thoughts on the issue with someone whom I respect has proven to be very effective for me, and my father has always been the most helpful individual to turn to in these situations. Faced with the situation of the level of invasiveness should be used in the case of Patient A, I called my father to discuss the matter [9]. Essentially what he told me was that I should be careful with my approach, but overall I should trust my personal judgement and what I feel would be ideal for Patient A [9]. He stated that I need to remember that Patient A knows that I want to make the best decision for him, and that, even if some risk is involved, I should do what I feel would be the most beneficial for the patient [9]. My father was not the only outside source that I considered; I often turn to deep personal thought in nature when faced with a challenging situation. Ever since I was I child, I have always integrated nature into my life whether it be for recreational sports or hiking with friends and family. In order to help resolve this current dilemma, I took a day hike alone along a state trail so I could weigh my options away from the strong, conflicting emotions of others [10]. The seclusion, along with being surrounded with the serenity of nature, allowed me to make a better informed decision for Patient A’s situation [10]. Utilizing both my father and nature significantly aided in the determination of my approach towards the issue at hand. Several other engineers and academics have published articles on ethical issues regarding invasiveness. Dr. Walter Glannon of the University of Calgary published an article detailing his own views on the ethics of BMIs, which involves his opinion on the benefits and risks of the invasive versus the noninvasive method [3]. After stating the known pros and cons of degree of invasiveness, Glannon reached a conclusion on what he believes to be the most ideal level of invasiveness [3]. He finished his ethical analysis by favoring the invasive approach on the grounds that “[a more invasive BMI] does not imply an unacceptable degree of risk” [3]. Glannon believes that the potential advantages of the invasive BMI outweigh the safer approach of the noninvasive interface [3]. Dr. Mary Jane Schneider of the University of North Dakota et al. published a paper that also discussed the ethics of brain-machine interfaces [8]. After examining multiple cases where BMIs were used as treatment, the group determined that while the invasive method is more helpful, the technology has not developed enough to use them in 2 Max Baxter clinical cases with humans [8]. Despite favoring the noninvasive method currently, Schneider and her associates recognize that the invasive approach will be the best option in the future [8]. It is important to consider the perspective of other engineers or academics to perhaps view the issue in a manner that was not previously apparent. this device. The noninvasive approach is also not going to be as effective as the invasive, and there is a lot more room for error [5]. Therefore, the partially invasive brain-machine interface, which would be implanted within the skull, but outside the brain itself, is the ideal treatment for Patient A. The partially invasive BMI has the most ideal benefit to risk ratio as it is more practical and still offers a long term viable solution. A partially invasive brain-machine interface is ideal for Patient A when considering his situation, the Code of Ethics for both the BMES and NSPE, and my moral obligations as a neural engineer. REACHING THE FINAL VERDICT When faced with any ethical impasse such as the one with Patient A, all professional engineers should use similar key tactics to reach the final decision regarding how the problem will be handled. Consulting any engineering society or organization’s Code of Ethics is principal to determining the approach. The Codes of Ethics are often very applicable in these scenarios, and even if certain statements seemingly contradict others, understanding which aspects of a situation are the most important is crucial for a successful decision. Utilizing the Code of Ethics maximizes professional integrity due to the fact that they help engineers focus in on the nuances of the situation; this allows for careful assessments of the problem at hand. Regardless of the societally accepted ethics in the medical field at hand, it is also essential that the engineer is confident with their decisions. Therefore, the engineer is consequently the most qualified to make the decision to approach the ethical dilemma. This confidence will significantly aid in making the best decision as it will allow the engineer to analyze the different options more thoroughly. It is also important to consider the perspective of other experts in a given scenario since they can help shed light on a different means of approaching a problem that might not have been previously recognizable. One final tactic for engineers to implement when facing a challenging ethical situation is to take advantage of any outside sources that you have whether it be talking with a family member or friend, or consulting a certain religion or faith. Everyone involved in the situation recognizes that the engineer understands the innovation or technology involved the best. Using these outside sources can help clear an engineer’s mind and consequently allow them to determine the ideal decision. Upon considering the Code of Ethics for both the BMES and NSPE, I have concluded that Patient A should be treated with a partially invasive brain-machine interface. Patient A originally stated that he would like to implant the interface within the grey matter of the brain, in order to maximize potential benefits [2]. This would have been the most invasive implantation available. After consulting the codes and additional sources, I, as the neural engineer, have determined that the prospective advantages do not outweigh the risks. I am responsible for maintaining the patient’s health, and do not want to risk harming his welfare [4]. I had considered recommending the noninvasive BMI; however, it is simply impractical for a man of his young age to be able to function in everyday life with REFERENCES [1] National Society of Professional Engineers. (2015). “NSPE Code of Ethics for Engineers.” Journal of the National Society of Professional Engineers. (Online Article). http://www.nspe.org/sites/default/files/resources/pdfs/Ethics/ CodeofEthics/Code-2007-July.pdf [2] J. Lahr. (2015). “Invasive brain-machine interfaces.” University of Freiburg Journal of Neural Engineering. (Online Article). http://material.bccn.uni-freiburg.de/publicationsbccn/2015/Lahr15_1.pdf [3] W. Glannon. (2014). “Ethical issues with brain-computer interfaces.” Frontiers in Systems Neuroscience. (Online Article). http://journal.frontiersin.org/article/10.3389/fnsys.2014.0013 6/full [4] Biomedical Engineering Society. (2014). “Biomedical Engineering Society Code of Ethics.” Journal of the Biomedical Engineering Society. (Online Article) http://bmes.org/files/2004%20Approved%20%20Code%20o f%20Ethics(2).pdf [5] F. Cincotti, D. Mattia, F. Aloise, et al. (2011). “Noninvasive brain-computer: Towards its application as assistive technology.” Brain Research Bulletin. (Online Article). http://www.springer.com/cda/content/document/cda_downlo addocument/9783642020902-c1.pdf?SGWID=0-0-451015086-p173959822. [6] G. Baranauskas. (2014). “What limits the performance of current invasive machine interfaces?.” Frontiers in Systems Neuroscience. (Online Article). http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4010778/ [7] B. Graimann. (2011). “Brain-Computer Interfaces: A gentle Introduction.” The Frontiers Collection. (Online Article). http://www.springer.com/cda/content/document/cda_downlo addocument/9783642020902-c1.pdf?SGWID=0-0-451015086-p173959822. [8] M. Schneider, D. Steines, D. Szibbo, et al. (2012). “Ethical Issues in Brain-Computer Interface Research, 3 Max Baxter Development, and Dissemination.” Journal of Neurologic Physical Therapy. (Online Article). http://journals.lww.com/jnpt/Abstract/2012/06000/Ethical_Is sues_in_Brain_Computer_Interface.8.aspx [9] D. Baxter. (2015). “Personal Interview.” [10] M. Baxter. (2015). “Personal Interview.” ADDITIONAL SOURCES P. Anderson. (2015). “Paralyzed Patient Uses BrainComputer Interface to Walk.” Medscape. (Website). http://www.medscape.com/viewarticle/852053 P. Ifft. (2013). “Brain-Machine Interface Enables Bimanual Arm Movements in Monkeys.” Science Translational Medicine. (Website). http://europepmc.org/articles/pmc3967722 S. Silvoni, M. Cavinato, C. Volpato, et al. (2013). “Kinematic and neurophysiological consequences of an assisted-forcefeedback brain-machine interface training: a case study.” Frontiers in Neurology. (Website). http://journal.frontiersin.org/article/10.3389/fneur.2013.0017 3/full ACKNOWLEDGMENTS I would like to thank the following individuals: my writing instructor, Dan McMillan, for the helpful advice in crafting the paper, my friends for discussing my ideas with me. 4