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Ethics in Bioengineering

ABSTRACT. Bioengineering, as the decisive extension of engineering action to human life itself, constitutes a fundamental enlargement of the technical realm, and calls for a commensurate expansion of ethical reflection. In fact, the engineering profession has been actively pursuing the development of new ethical codes, and the promotion of ethics by bioengineers both in the United States and on the international level deserves philosophical recognition and support.

Consider the following hypothetical cases: o Pressures in the developmental schedule for a new transport vehicle inspired by biomechanical studies of beetle physiology lead to the faulty design of a key component. Although called to the attention of superiors in the company, it goes unrepaired. As a result there are eventual injuries and deaths associated with vehicle use. o A biomedical engineer gives birth to an infant with a rare but fatal deformity. However, it is a deformity which, because of her technical knowledge, she could remedy by inventing a special prosthetic device. She decides not to make the invention and allows her child to die. Anyone acquainted with the recent histories of ethics and technology will readily recognize these as containing analogies to the DC-10 and Baby Doe cases. In 1974 an improperly designed cargo bay

Carl Mitcham is Associate Professor of Philosophy and of Science, Technology, and Society at Pennsylvania State University. His previous publications include Philosophy and Technology (1972, 1983), Philosophy and Technology II (1984), and 8Qu6 es la filosofia de la tecnologia? (1989).

Journal of Business Ethics 9:227--231, 1990. © 1990 KluwerAcademic Publishers. Printed in the Netherlands.

Cad Mitcham

door on the new DC-10 went uncorrected and caused the worst crash in civil aviation history. In 1982 in Indiana, a Down's syndrome baby born with a deformed esophagus was refused treatment by his parents and allowed to die. The practice of bioengineering, like the practice of other fields of science and technology, is increasingly aggravated by such sensitive moral problems. But bioengineering may take the issues of ethics to new depths. Consider, for comparison, two further possible cases: o An individual with a prosthetic leg is mugged and his leg severely damaged. No part of his organic body has been harmed. Has he been battered or merely assaulted and robbed? o A fanaticist wilderness group is trying to preserve a species of sea turtle that lays its eggs on a small beach threatended by development. Were a bioengineer to propose that some turtles be fitted with bioinstrumentation to redirect them to a new and more protected beach of a virtually identical ecology, would environmentalists criticize this as doing violence to nature?

T h e d i m e n s i o n s o f ethics Bioengineering, as the application of engineering methods and knowledge to biology and medicine, constitutes a decisive extension of engineering beyond its previous restriction to the non-human and even non-living world. The classical fields of civil, mechanical, electrical, and electronic engineering all focused on making (to adapt a standard definition) "the properties of matter and resources of energy in nature available to human use." Bioengineering

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extends engineering theory and practice into the lifeworld. In its broadest senses it includes biomedical engineering, genetic engineering, biotechnology, biomechanics, bioelectronics, bioinstrumentation, etc. As such, it makes the resources of life available to life itself- and because of this recusive character requires perhaps more than any other branch of engineering a certain degree of self reflection. The most general discipline of human self reflection is ethics, the study of the nature and meaning of human activity. The fundamental insight of ethics is that human beings have available to them more opportunities for action than they can possibly realize, and that therefore they must choose to do some things and not to do others. Choices in human behavior, at least in crucial instances, escape the boundaries imposed by physical limitation, biological constraint, economic exigency, and social-psychological influence. As a result, human beings necessarily develop ideas or theories or rational arguments concerning right and wrong, good and bad. The history of ethics constitutes the articulation of alternative theories together with alternative explications of the nature of the right and the good. Bioengineering, by extending human activity into new areas, implicitly calls for the re-application of traditional theories as well as the articulation of new and more adequate theories. Ethics is not only a challenge to bioengineering, bioengineering is equally a challenge to ethics. But professional bioengineers may well be meeting their challenge better than professional ethical philosophers.

Meeting the challenge Over the last three decades, during the same period that has witnessed the development of bioengineering as a fertile interdisciplinary field, there has also arisen among scientists and engineers a new interest in the ethical implications of their work. This is perhaps most noticable, in association with the practice of medicine, in the creation of the wholly new discipline of bioethics, but it has also been manifest among professional engineers. 'Engineering as a recognized profession originates with the 18th century formation of the first engineering societies. The initial ethics codes for these

formulated in the early 1 9 0 0 s - - modelling themselves on the ethical codes of the more traditional professions of physicians and attorneys stressed the obligation of the engineer to a client. The problem is that this client was usually an employer, a corporation, so that company loyalty came to be construed as the primary obligation of the practicing engineer. If a physician was not free to publicize the illness of a patient, neither was it legitimate for an engineer to "blow the whistle" on an employer. During the decade of the 1970s, however, this conception of engineering ethics underwent a decisive change. Under the influence of the consumer and environmental movements - and highlighted by a series of dramatic engineering failures such as the 1972 Bay Area Rapid Transit (BART) case, the 1974 Paris DC-10 crash, and the meltdown of the Three-Mile Island nuclear power plant in 1979 the engineering profession began to reconceive its ethical obligations in terms of responsibilities to public welfare and to defend whistle blowers. The BART case is particularly revealing in this regard. Three engineers independently came to the conclusion that passenger safety was at risk, opposed management, and were fired. Subsequent investigations and a dramatic accident confirmed their concerns and engendered strong professional support for actions which in the past would have been viewed as company disloyalty. This was the first instance in which professional engineering societies publicly criticized a major engineering employer. Changes within the Institute of Electrical and Electronic Engineers (IEEE), the largest professional engineering society in the world, well exemplify this transformation. As the engineer Stephen Unger writes in his book, Controlling Technology: Ethics and the Responsible Engineer, "Prior to 1972, the IEEE functioned almost exclusively as an organization for promoting the development, application, and exchange of technical information." But because of '% popular demand within IEEE for a broadening of its scope," the society undertook a number of ethicsrelated initiatives. ~ Among these was the formation of a Committee on Social Implications of Technology, which in 1982 was upgraded to the status of a society and began publishing a quarterly, the IEEE societies,

Technologyand SocietyMagazine.

Ethics in Bioengineering

The bioengineering profession The first professional organizations for bioengineers were formed just prior to these events within the larger engineering community, and - as is understandable - focused during their development phase precisely on "promoting the development, application, and exchange Of technical information." But in the early 1980s there began to be calls for the discussion of ethical issues, especially among bioengineers working in a clinical setting.2 The professional bioengineering commmunity has :begun to respond to such calls. For instance, "in an effort to provide a forum to discuss engineering views related to health care policy, the lEER (in 1986) established the Health Care Engineering Policy Committee" which, as one of its initial projects, organized four symposia on Ethical and Policy Issues in Health Care for the 1987 Conference of the IF.EE Engineering in Medicine and Biology Society. 3 The general aim was to examine o the safeguarding of human subjects in biomedical engineering research, o the decision-making process in relation to the development of new medical devices in a reasonable time, o the ethics and economics of life-extending technologies, and o the utilization of computer models to replace animals in research. A revised and amplified set of papers appeared in the IEEE Engineering in Medicine and Biology Magazine. According to one contributor: Clinical engineeringpractice is marked by varied responsibilities and tasks, such as equipment acquisition, personnel management, equipment utilization, risk management, and technology assessment. In performing these duties, issues arise that deserve consideration,such as employee safety, working out of title, cost-effectiveness and productivity, unpopular causes, standards and regulations,quality assurance, and whistle blowing? Specific position papers have argued for the inclusion of qualified engineering personnel in pertinent interdisciplinary health care teams and related government commissions. A proposal has also been

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made that the FDA do a failure analysis in the evaluation of medical devices. All such arguments regarding the use or inclusion of certain kinds of technical expertise and procedures necessarily transcend the narrowly technical realm and engage ethical decision-making among alternative courses of action.

T h e i n t e r n a t i o n a l perspective Parallel to this effort within one national bioengineering professional organization, ethical studies have been initiated at the international level. In 1986 the International Federation for Medical and Biological Engineering (IFMBE), with over thirty affiliated national societies, undertook an inventory of existing ethical codes and related needs. The preliminary report on this research reveals that while no bioengineering society as yet has its own professional ethics codes, there is considerable recognition that a variety of moral issues are associated with bioengineering practice. The ethical issues specifically identified focus on problems related to o the difficulties of determining the effectiveness of complex, expensive, new high technolo-

gies; o decisions about when to utilize life-extending technologies with critically ill patients; o organ transplantation and the selection of both recipients and donors; o the impact of new diagnostics and therapeutics on neonatal care; o fetal research and its methods; o the application of cost-effectiveness assessments (Cost to whom? Effective for whom?); o individual and collective responsibilities within interdisciplinary health care teams; o the influence of medical technology on the

physician-patient relationship; o the promotion of information and education of individual bioengineers, among bioengineers and others working on health care teams, and of patients; o how business arrangements can affect bioengineering work; and

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o the guidelines for research with humans and animals. The case of the artificial heart designed by bioengineer Robert Jarvik and implanted in Barney Clark in Utah in 1982 illustrates a host of these issues. As with any such hightech biomedical device, determination of effectiveness is difficult and essentially requires experimentation on human subjects. Even when there are more volunteers than needed, criteria have to be developed for choosing among critically ill patients who may not be able to exercise the most informed and rational consent. The utilization of expensive resources to preserve the lives of already critically ill patients when much smaller sums of money allocated to preventative medicine and education can benefit many more lives has been highly debated. The interrelationships among members of a health care team using the Jarvik-7 are easily influenced by financial and public relations interests, as the move of implant surgeon William De Vries from the University of Utah to the Humana Hospital Corporation in Louisville attests. In short, in many such hightech bioengineering efforts, non-technical and ethical considerations easily play a major role in determining application and utilization. Attention is also drawn in the IFMBE report to a recent United Nations resolution regarding "Human Rights and the Use of Scientific and Technological Developments" (1987) and efforts of the World Health Organization Working Group on Technology in Hospitals to "promote discussions of ethics in the health care syste m as a whole, with particular reference to the use of technology." Against this background, an argument is made regarding the need for a bioengineering code of ethics that would "inspire to a high morality . . . and make the engineer aware of moral aspects of his or her work." 5 Ethics is a concern of biomedical and clinical engineers. Their tasks do often mean contributions in medical interventions which are delicate from an ethical viewpoint. Limited resources raise the need for cost-effective technologies. The biomedical or clinical engineer has important knowledge of risks and effectivness. An organization where this knowledge is effectively communicated within the care team is imperative. The

responsibilities of the parties involved in health care should be continuously revised?

Beyond the clinical setting Clinical biomedical engineers are becoming increasingly sensitive to the kinds of ethical issues that are now the staple of medical practice. Certainly the introduction of bioethical discussion into the engineering field constitutes a unique development in professional engineering ethics. As Aristotle pointed out, one deliberates about what it is in ones' power to do. 7 Since bioengineering enlarges human power, it perforce calls for expanded ethical deliberation. Indeed, there is impressionistic evidence that the bioengineering profession is especially attractive to persons who are already sensitive to ethical reflection in this new dimension. Some of the best graduate students choose bioengineering - and reject such fields as computer science - in order to pursue leading-edge research funded by non-defense contracts. The head of one major bioengineering program explains his switch from aerospace engineering as a desire to avoid the economic instability of the defense industry and to do work that is more directly beneficial to humanity. Such positions can have important implications for deepening the professional engineering commitment to public welfare. But bioengineering is more than clinical bioengineering. As such it also ultimately raises challenges to our moral understanding that transcend the ethics of complex, interdisciplinary health care. The second set of hypothetical cases described earlier point in this direction. The possibilities of bioengineering contain implicit questions about the boundaries of personal agency and distinctions between nature and artifice that have been central to major traditions of ethical theory and standard attempts to adjudicate right and wrong, good and bad. Are there artificial extensions of the body that can be incorporated into myself as a human agent? If so, where does one re-draw the line - which used to be drawn at the surface of my skin - between myself and my possessions? And in the world beyond my possessions, must artifice always be construed as an element in opposition to nature? Or can it become a legitimate extension of the non-human reality within which the human discovers itself as a fabri-

Ethics in Bioengineering cating animal? Mthough beyond the scope of the present discussion, these are the kinds of questions inherent in the most provocative bioengineering research into the modelling of natural systems and the reconstruction of biological evolution. Personal issues of clinical practice and public policy issues of resource allocation are but the surface of a discussion that must eventually engage all those who would reflect on the ethical dimensions of human existence, s

Notes

1 Stephen H. Unger: 1982, Controlling Technology:Ethics and the ResponsibleEngineer (Holt, Rinehart, and Winston, New York), p. 63. 2 See, e.g., Pamela Saha and Subrata Saha: 1981, 'The Need for Biomedical Ethics Training in Bioengineering', Biomaterials, Medical Devices and Artificial Organs 9, no. 4, pp. 369-370. 3 Joseph D. Bronzino: 1987, 'The Role of the Engineer and IEEE in Health Care Policy', Proceedingsof the Ninth Annual

Conference of the IEEE Engineering in Medicine and Biology

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Society (Institute of Electrical and Electronic Engineers, New York), vol. 1, p. 0018. 4 Joseph F. Dyro: June 1988, 'Meditation on Ethics in Clinical Engineering Practice', IEEE Engineering in Medicine and BiologyMagazine7, no. 2, p. 77. 5 Jan Persson: 1989, 'Ethical Codes in Biomedical and Clinical Engineering -- An International Comparison', (International Federation for Medical and Biological Engineering and Center for Medical Technology Assessment, Link6ping, Sweden), p. 6. Jan persson: 1989, 'Ethical Codes in Biomedical and Clinical Engineering - An International Comparison', (International Federation for Medical and Biological Engineering and Center for Medical Technology Assessment, Linktping, Sweden), p. 14. 7 Aristotle, NicomacheanEthicslII, 2 (1112a30-31). 8 Work on this paper has been supported in part by a grant from the Ethics and Values Studies Program of the National Science Foundation (#DIR8721989) to do research on engineering ethics outside the United States. An earlier, editorially distorted, version appeared in MechanicalEngineering (September 1989). Science, Technology and Society Program, Pennsylvania State University, Uniuersity Parfi, PA 16802, U.S.A.