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Copyright 0 1992 Taylor & Francis

Ethics Education at the Engineering/Medicine Interface A. U. “DAN” DANIELS, PHD

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University of Utah School of Medicine & College of Engineering Salt Lake City, UT 841 12 Symposia, like hard liquor, should be taken in reasonable measure, at appropriate intervals. . . . Also, if every symposiast were a Dr. Samuel Johnson, perhaps the intercalated discussions at a symposium might strike more fire and distill less mutual admiration. Sir Francis Walshe, 1888-1979’

Introduction With Sir Francis’s warning at hand, and though Dr. Johnson I’m not, I still hope that my part in these proceedings will strike a little fire. First, I want to ignite one to warm you to these ideas: The interface is real (at least in my area of bioengineering), the time is right for bioengineering ethics education, and there is a need. Then, by the light of what I hope is at least a modest blaze, I will discuss a curriculum and suggest some educational methods. Also, I shall define a bioengineer as anyone with an engineering degree whose principal professional focus is both technical and medical.

Orthopedics: A Functioning Interface I spend my professional life very literally at the engineering/medicine interface. I am an orthopedic bioengineer, and whether out of wisdom or pragmatism, orthopedic surgeons have seen fit to create quite a formal and intimate relationship between themselves and the engineers with whom they work. This is an alliance with several components. For example, the preeminent pure research journal in this field, the Journal of Orthopaedic Research,2 has been coedited by a surgeon and an engineer since its inception. Also, the preeminent clinical journal, the Journal of Bone and Joint Surgery,3 has an engineer as one of its two deputy editors for research. Further, the American Academy of Orthopaedic Surgeons has an associate membership category for those of us who have a principal involvement in orthopedics who are not orthopedic surgeons. This (albeit small) group is dominated by engineers, mostly from academic institutions. The Academy also has a Committee on Biomedical Engineering. For twenty years, a principal activity of this committee (containing surgeons and engineers) has been to represent the Academy in the American Society for Testing & Materials (ASTM) Committee F4 on Medical & Surgical Materials and Devices. ComAddress correspondence to A. U . Daniels, PhD, Division of Orthopedic Surgery, University of Utah, Salt Lake City, Utah 84132. 209

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mittee F4 has created and published numerous standard specifications, practices and test methods related to orthopedic implants and in~truments.~ And perhaps as a final measure of intimacy, the American Board of Orthopaedic Surgery includes questions on biomechanics in the exams it gives in connection with board certification of orthopedic surgeons. So, there is certainly a well-defined interface, at least for me and my immediate colleagues. Now we can move on to considering whether the time is right to make an increased effort for bioengineering ethics education.

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The Right Time Regarding ethical issues in general, I am also someone who, with increasing age, is as interested in helping bioengineering students and orthopedic residents gain a sense of the things they do as in mere technical knowledge. And ethics is central to a sense of things. As Albert Einstein said: A concern for man and his fate must always form the chief interest of all technical endeavors . . . never forget this in the midst of all your diagrams and equations.5 That is an excellent general position, but is this the right time to attempt more ethics education? Often, two or more individuals or groups develop and present the same new scientific findings or new technology at almost the same time. Giving such workers the ethical benefit of the doubt with regard to plagiarism, we take these occurrences to suggest that science and society reach states of knowledge and readiness in which such events are likely to occur, and therefore may well occur, in several places at once. There is substantial concurrent evidence that our society is ready for new and formal developments in the area of ethics/medicine/technology,and that therefore our colloquium is timely and would or will occur soon somewhere else as well as here. For example, the December 1989 issue of Academic Medicine was entirely focused on teaching medical ethics to physicians. The general thrust of the articles and editorials was that the time is upon us when ethics education should be (and is becoming) a formal part of the medical school curriculum, and should also be addressed specifically in resident education. In the journal’s literature review, Miles et a1.6 noted that in 1983 only 7% of medical schools required a separate course in medical ethics, while by 1989, 34% did. In addition, by 1989 almost 80% stated that the subject at least was covered specifically in other required courses. Such sentiments are also stirring in the government agencies that fund so much of our research in both medicine and engineering. Earlier this month, the NIH Guide to Grants and Contracts’ announced a series of regional workshops starting in April 1990 for “Promotion of Integrity and Responsible Practice in Biomedical Research,” sponsored jointly by the National Institutes of Health (NIH) and the Association of American Medical Colleges. Among other things, the workshops will cover the recent establishment of the Office of Scientific Integrity within the Public Health Service, the governmental body that includes NIH . Last year, the National Science Foundation (NSF) announced a program to fund “Undergraduate Curriculum Development in Engineering,” with the stipulation that among other things, such curricula “develop, in as individualized a way as possible, each student’s . . . recognition of engineering as an integrative process in which analysis

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and synthesis are supported with sensitivity to societal need,” and to meet “an increasing demand for engineers to be more informed about risk and uncertainty.”* For several years, the NSF has also had a research grant program entitled “Ethics and Values in Science and Technology.” Even the scientific press seems increasingly ethics-oriented. The biweekly newspaper The Scientist (now in its fourth year of publication) states that its editorial position includes a “commitment to open discussion of controversial topics.”’ More often than not, this means coverage of events with strong ethics content. For example, headlines in the referenced 1990 issue include “Misconduct Office Vows to Keep Actions Secret,” “Panel Urges Closer Scrutiny of New Medical Technology,” and “Activists Press for Open Meetings to Review Research Using Animals.” In spite of these signs, I am not aware of any previous concerted interest among educators in adding medical ethics to the bioengineering curriculum. To my knowledge, the only frequent and consistent advocates of such considerations in print have been Saha and Saha.”- ” We are indebted to them for keeping the issue of ethics in bioengineering alive for the past several years.

What Is The Need? So, the engineering/medicine interface exists; the time for increased ethics education seems to be upon us. But what is driving these events? What is the need? I believe ethics education is needed at this interface to facilitate communication, extending it beyond technical matters. In turn, the purpose for this communication is to enhance decision making to further ensure both patient safety and the efficacy of patient treatment. A strong secondary purpose is to achieve what I call social economy-efficient use of technical resources, and therefore of public and private funds. But why ethics? Why not just more technical information? Because the technical knowledge bases in both engineering and in medical biology are rapidly becoming larger and more complex. Increasingly, the bioengineer and the physician are less likely to be able to grasp all the technical knowledge on both sides of the interface. Increasingly, therefore, they must rely on one another’s judgment. In this case, communication is likely to be better if they know where the other profession is coming from-what is the basis for the judgment. And ethics provides the foundations on which judgments are made.

Tsward an Ethics Curriculum for Bioengineers This problem of running order through chaos, direction through space, discipline through freedom, unity through multiplicity has always been, and must always be, the task of education. Henry Adams” Everything should be made as simple as possible, but not simpler. Albert Einstein’’ As the quotes above suggest, curriculum development is essential to education, and both the content and the methods require substantial efforts to balance clarity with completeness. This section does not presume to give an entire curriculum, but is intended to provide ideas to help us see how ethics education applies to professional activities and to move toward such a curriculum as time and resources allow at interested institutions.

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As I stated at the end of the Introduction, the purpose of a curriculum addressing ethics at the engineering/medicine interface is to facilitate interdisciplinary communication and therefore the quality of resultant (unilateral or mutual) decisions by bioengineers and physicians that ultimately affect patients. Engineers are ordinarily involved in one or more of the following activities requiring decision making:

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Research & development Materials Devices Manufacturing Methods development Process control Test & evaluation Quality control In-use data acquisition Post-use evaluation (failure analysis) Professional service Teaching Standards development (specifications, test methods) Publishing process (reviewing, editing) Expert legal testimony Bioengineers generally have the same activities as other engineers, only the focus is on medical devices and materials for diagnosis and treatment of illness and injury. Interestingly, the activity mix for physicians is similar to that for engineers, except that for practicing physicians, manufacturing is replaced by patient care, and patient care comes before all other activities in ethical order of importance. Patient care is also generally personal, and it is rare for engineers to provide service directly to an individual. It also takes only a moment of reflection on each of these activities to realize that each one has substantial ethics content. So, we can conclude that ethics is important in all aspects of professional practice for both disciplines.

Cumkulum Content As I said at the end of the Introduction, each of the two disciplines must understand where the other is coming from. In this sense, ethics is an essential element, but cannot come first. Bioengineers need to know first how medicine and surgery are taught and practiced. Although not covered here, collaborating physicians need to have the same understanding of engineering. Although many engineering and medical activities are analogous, the nature of medical education and the nature of medical practice (that is, how the activities are performed) are quite foreign to engineering experience. In outline form, here are some principal areas in which bioengineers need to gain an understanding of medical education and practice: Medical education Case study method Medical school curriculum Internships

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Residencies Fellowships (after residency) Continuing medical education

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Medical practice Decision-making methods (Dx,Rx) Individual physician responsibility Referral system Economics (costs, charges, insurance) In general, medical education’s use of real case studies and Socratic dialogue is foreign to engineering education. Student engineers hear lectures and do story problems, perform laboratory experiments and may do laboratory research. But they do not review numerous examples of actual engineering practice, nor do they generally participate heavily as apprentices in any aspect of engineering except research (as graduate students). Bioengineering students need to understand the nature of case study education, and how this approach permeates the entire process of medical education from the third year of medical school onward. They also need to understand the purpose of postgraduate medical training and the role/status of physicians in the various training stages. With respect to medical practice, bioengineers need to become acutely aware that, in general, individual physicians make the key diagnosis and treatment decisions for individual patients and/or decide to refer them to other physicians with other skills. They need to understand how this individualism helps create the possibility of different diagnoses and treatments for what may be generally the same or similar pathologic conditions. With at least a basic understanding of the nature and structure of medical education and practice, the bioengineer is prepared to consider the subject of medical ethics. According to Miles et al.,6 there are five goals of ethics education for physicians. Below, I have modified these goals to produce a set of goals of ethics education for bioengineers, mainly by substituting the word bioengineer for physician and modifying references to clinical activities to reflect bioengineering activities. The goals are: To teach bioengineers to recognize the humanistic and ethical aspects of bioengineering careers To enable bioengineers to examine and affirm their own personal and professional moral commitments To equip bioengineers with a foundation of philosophical, social, and legal knowledge To enable bioengineers to employ this knowledge in their professional activities To equip bioengineers with the interactional skills needed to apply this insight, knowledge, and reasoning as a member of a team of health care professionals whose end goal is safe and efficacious patient care

In addition to goals, Miles et a1.6 list seven main areas of content, with numerous subareas under each. The complete listing is in the table. Four of the seven areas seem appropriate to me as basic contents for an ethics curriculumfor bioengineers: Professional ethos Multidisciplinary issues Patient autonomy and clinical dilemmas Social issues

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Eible Content Areas for Medical Ethics Education*

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Ethical theory and humanities Basic bioethical concepts Religious theory and medicine Humanities Professional ethos Codes of ethics in medicine Physician bias about patient’s quality of life Duty to treat HIV-infected persons Compassion Rights and duties of doctors Determination of death Pain control Organ donation, requests, selecting recipients Innovative technology Physicians and cost constraints or economic incentives Multidisciplinary issues Impaired colleagues Consultation and team ethics Differences with colleagues Relations with lawyers, nurses, and reporting agencies Use of ethics consultants and committees Patient autonomy and clinical dilemmas Autonomy and personhood How patients relate risk to values Obtaining consent Patients’ refusal of recommended treatments Truth-telling and withholding information from patients Patient privacy and confidentiality Evaluation of decision-making capacity

Proxy consent, informed consent, coerced consent Role of families in treatment decisions Sexual responsibility Abortion Defective newborns Maternal-fetal conflicts Rights of children, psychiatric patients, handicapped persons Artificial insemination, in vitro fertilization Care of the dying, comatose, or hopelessly ill Forgoing life support Euthanasia Student physicians Academic integrity Revealing student status to patients Student’s feeling of excess entitlement Disclosure of new information to patients Role of student physicians Academic medicine Authorship Research ethics Social issues Preventive medicine; health and disease concepts Justice and health care Legal medicine, forensic medicine, malpractice Nuclear war Genetics Community service

*Adapted from Miles et aI6 by permission of the Association of American Medical Colleges.

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In these four main areas are some subareas that I think are particularly important to bioengineering ethics education: rights and duties of physicians; determination of death; conditions for use of innovative technology; cost constraints; team ethics; patient privacy and informed consent; research ethics; and malpractice.

Curriculum Methods

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How do we teach a bioengineering curriculum that will achieve the goals and cover the content described above? I believe that the best approach involves both informal and formal activities, and that they are of equal importance. Informal Activities. Based on my own experience, I believe a substantial understanding of medical education, practice, and ethics can be achieved informally through exposure and proximity of bioengineering students to medical students, residents, and practicing physicians. I also believe this exposure is most appropriate and effective for graduate students rather than undergraduates. The possession of a degree and admission to graduate study places the bioengineering students at an equal educational level with medical students, and the academic achievement represented by an engineering degree is widely respected. I think these credentials are an aid to necessary communication. The informal exposure must also be of sufficient length. In my experience with students, the two-plus years required to obtain an MS degree is sufficient to gain at least basic information and perspective. Attendance at weekly orthopedic resident conferences where patient x-ray films are reviewed, and also monthly grand rounds, have become key informal (but required) activities for my students. The conferences expose them to the case study education method as well as to ethical issues. The grand rounds give them broad perspective on the safety and efficacy of specific techniques for orthopedic treatment and diagnosis, and the conduction of clinical trials. Of course, these techniques are frequently based on engineering-derived technology. Where desired, this informal exposure can be formalized by creating independent study courses in which attendance at conferences is supplemented by directed reading, and the student is required to produce a term paper demonstrating his or her grasp of some part of orthopedic technology and/or ethical issues. I believe it is also vital for bioengineering students to witness surgery on human patients in the operating room (or to witness some other type of patient care directly, if their field of graduate study does not involve-devices used in the operating room). This must be accomplished in accord with established hospital policies, and this has proved possible in our institution for students formally affiliated with our research program. The activity should be repeated periodically during the course of study, as the students’ formal knowledge increases. Another highly effective activity for teaching bioengineering ethical issues informally is collaborative research work. This should involve bioengineering graduate students with either medical students or residents. The mutual efforts remove barriers, and especially in the absence of faculty, frank discussions frequently ensue regarding not only the rigors of medical training and engineering graduate study, but also patient treatment problems, which frequently have high ethics content. If the projects also involve a practicing surgeon on the faculty (as ours usually do) this provides the bioengineering student with additional valuable exposure in a setting that is still less formal than patient conferences or grand rounds.

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Formal Activities. At medical schools where such courses exist, one formal option is to arrange for bioengineering graduate students to attend all or part of an ethics course intended for medical students. Such a course is in the planning stages at our institution. The director of the fledgling medical ethics section in our school's department of internal medicine feels that such participation could bring useful expertise and perspective on technology to the course. The other formal approach is to offer, through an institution's bioengineering program or department, a course that is devoted to medical ethics or includes a strong medical ethics component. Our bioengineering department does not yet have a course exclusively devoted to medical ethics for bioengineers. However, some ethical issues are covered in several of our regular technical courses, and I have given one course in which ethics was a major component: Surgical Implants-Efficacy, Ethics and Economics. In the efficacy portion of the course, surgeons lectured frankly on their experience with the clinical performance of specific surgical implants, including prosthetic heart valves, hydrocephalus shunts, mammary prostheses, and total knee replacements. I also added information obtained through analysis of clinically retrieved implants. In the ethics portion, students heard a lecture from the vivarium director (a veterinarian) on animal research and visited the vivarium, a lecture on patient rights and surgical malpractice from an attorney who is also a licensed physician, a lecture from the chairman of our hospital's institutional review board on clinical research, and a lecture from me on voluntary standards and government regulation of medical devices. In the economics portion, the students heard lectures from a patent attorney, from both bioengineering faculty and medical device manufacturers on the costs of implant research, development, and manufacturing, and from a hospital administrator on the impact of new technology on the cost of hospital services. About a dozen students enrolled in the course, and the lectures were arranged so that there was ample time for questions and free-wheeling discussion after lectures. I also arranged for the course to be designated officially as writing intensive by our university's Writing Program for two reasons. First, I think that issues of the type raised in such a course cannot be considered deeply by students unless they write about them at length. I believe strongly that the writing process is a learning process. In addition, I believe engineering students do not do enough writing during their undergraduate or graduate education. This is particularly troublesome in graduate education since many of the students are embarking on research and/or academic careers in which they will spend a major portion of their time writing. The course was well received, and I hope we will be able to make it a regular part of our bioengineering curriculum. In the future I would add someone trained in bioethics to the group of lecturers. Currently, I would also expect to make three of the papers by Saha and Saha1'312z'4 and the review by Miles et aL6 required reading, and also select additional reading material.

Summary There is a functioning interface between engineering and medicine. There are also widespread indications in the scientific community that there is increased concern for ethical matters in science and that the time has arrived for more instruction in this area. One reason for this in bioengineering is the rapidly growing complexity of technology in both engineering and medical biology. The ensuing difficulty in communication cannot be remedied just with more technical information. Instead bioengineers need an improved

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understanding of medical education and practice, and medical ethics is fundamental to this. Ethical considerations are crucial to decision making and therefore to all areas of professional endeavor in bioengineering. As a framework for ethics education, bioengineers need to gain a better understanding both of medical education in general and of medical practice, particularly the case study method in education and the nature of decision malung in medical practice. Key subject areas in medical ethics for bioengineers include rights and duties of physicians, determination of death, team ethics, patient privacy and informed consent, research ethics, and malpractice. An ethics curriculum for bioengineers should be taught using both informal but regular exposure to clinical activities and clinicians, and formal classroom work. In the medical ethics classroom setting, writing assignments are essential to provoke each student to the introspection and commitment needed to form a personal professional ethos.

References 1. Walshe, F. William Harvey upon Lord Chancellor Bacon: being a text for some reflections upon critical thinking and writing in medicine and medical sciences. Perspect Biol Med. 1959; 2: 197-207. 2. Journal of Orthopaedic Research, Akeson W, Hayes W (eds). New York: Raven. (Official journal of the Orthopaedic Research Society, published six times yearly.) 3. Journal of Bone and Joint Surgery, Cowell HR (ed). Boston, MA: Journal of Bone and Joint Surgery, Inc. (Official journal of the American Academy of Orthopaedic Surgeons and 12 other orthopaedic societies; American volume, 10 issues yearly.) 4. Annual Book of ASTM Standards, Vol 13.01, Medical Devices. Philadelphia, PA: American Society for Testing & Materials; updated and published yearly. 5. Einstein A. Science and society. In Out of My Later Years. New York: Philosophical Library; 1956. 6. Miles SH, Lane LW, Bickel J, Walker RM, Cassell CK. Medical ethics education: coming of age. Acad Med. 1989; 64( 12):705-714. (Formerly Journal of Medical Education.) 7. Announcement: promotion of integrity and responsible practice in biomedical research; AAMC/NIH Regional Workshops. NIH Guide to Grunts and Contracts 1990; 19(11):2-3. 8. Program announcement and guidelines: undergraduate curriculum development in engineering. Program for Undergraduate Science, Engineering and Mathematics Education, National Science Foundation, Washington, DC; closing date: February 10, 1989. 9. Publisher’s information section, The Scientisr 1990; 4(6):2. 10. Saha S, Saha P. The need of biomedical ethics training in bioengineering. Biomuter Med Devices Artif Organs. 1981; 9(4):369-70. 11. Saha S, Misra S , Saha P. Bioengineers, health-care technology and bioethics. J Med Eng Echnol. 1985; 9(2):55-60. 12. Saha P, Saha S. Ethical responsib es of the clinical engineer. J Clin Eng. 1986; 11(1): 1725. 13. Saha S, Saha P: Bioethics and applied biomaterials. J Biomed Muter Res. 1987; 21(A2):181190. 14 Saha P, Saha S. Clinical trials of medical devices and implants: ethical concerns. IEEE Eng Med Biol Mag. June 1988; 7:85-87. 1.5 Saha S, Saha P. Should bioethics be part of clinical engineering curriculum? Transactions of the 1988 World Congress on Medical Physics and Biomedical Engineering, BE4-E.4, San Antonio, TX, 1988. 16 Saha S, Saha P. Ethical issues and professionalism in clinical engineering. Proceedings of the 24th Annual Meeting of the American Association for Medical Instrumentation, St. Louis, MO, May 1989.

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17. Saha S, Saha P. Emerging ethical issues in bioengineering practice. 11th Annual International Conference, IEEE Engineering in Medicine and Biology Society, 1555-1556 June 1989. 18. Adams H. The Education of Henry A d a m . Boston, MA: Houghton Mifflin; 1918. 19. Einstein A: The fundaments of theoretical physics. In Out of M y Later Years. New York: Philosophical Library; 1956.

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