Appendix E Bioengineering Ethics: The Ethics of the Linkage Between Engineering and Biology1

George Bugliarello

INTRODUCTION

Bailey’s dictionary, the forerunner in 1730 of Samuel Johnson’s famous dictionary, defines ethics as “a science which skews those rules and measures of human actions which lead to true happiness; and that acquaints us with the means to practice them.”2 Webster’s unabridged dictionary defines ethics as the discipline dealing with what is good and bad or right and wrong and with moral duty and obligation.3 Indeed, in the most fundamental sense, ethics has to do with the distinction between right and wrong, between good and bad. A guide for action that may have operationally the semblance of an ethic instinct is encountered in some animal species. It is an instinct that makes the animals that possess it willing to sacrifice their lives for their offspring, or for members of their social group. However, it is only humans, and perhaps some higher animals closer to our species, that have a conscious ethics—a reasoned ethics.

Conscious ethics—or, ethics for short—was originally the domain of religion. But in the West, under the pressure of philosophy, starting with Greek philosophy, ethics became the domain of philosophical inquiry. In turn, science, with its discoveries, pushed religion and helped shape views

1  

Based on the Keynote Speech at the First International Conference on Ethical Issues in Biomedical Engineering, Clemson University, September 29, 1997.

2  

Bailey, N., Dictionarium Britannicum. Cox: London, 1730.

3  

Webster’s Third New International Dictionary of the English Languages, Unabridged. Merriam: Springfield, MA: 1968.



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Appendix E Bioengineering Ethics: The Ethics of the Linkage Between Engineering and Biology 1 George Bugliarello INTRODUCTION Bailey’s dictionary, the forerunner in 1730 of Samuel Johnson’s fa- mous dictionary, defines ethics as “a science which skews those rules and measures of human actions which lead to true happiness; and that ac- quaints us with the means to practice them.”2 Webster’s unabridged dic- tionary defines ethics as the discipline dealing with what is good and bad or right and wrong and with moral duty and obligation.3 Indeed, in the most fundamental sense, ethics has to do with the distinction between right and wrong, between good and bad. A guide for action that may have operationally the semblance of an ethic instinct is encountered in some animal species. It is an instinct that makes the animals that possess it willing to sacrifice their lives for their offspring, or for members of their social group. However, it is only humans, and perhaps some higher ani- mals closer to our species, that have a conscious ethics—a reasoned ethics. Conscious ethics—or, ethics for short—was originally the domain of religion. But in the West, under the pressure of philosophy, starting with Greek philosophy, ethics became the domain of philosophical inquiry. In turn, science, with its discoveries, pushed religion and helped shape views 1 Based on the Keynote Speech at the First International Conference on Ethical Issues in Biomedical Engineering, Clemson University, September 29, 1997. 2 Bailey, N., Dictionarium Britannicum. Cox: London, 1730. 3 Webster’s Third New International Dictionary of the English Languages, Unabridged. Merriam: Springfield, MA: 1968. 42

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43 APPENDIX E of the world on which ethics considerations are based. And now engi- neering also is putting pressure on science, philosophy and religion in terms of ethics. ENGINEERING, SCIENCE, AND MEDICINE In the broadest sense, engineering can be defined as an activity di- rected toward the modification of nature, from altering genes to the con- struction of bridges, from space flights to the fighting of disease—all pro- cesses or artifacts that did not exist in nature. This modification of nature is in effect a continuation of biology by other means, so that engineer- ing—whether traditional engineering or genetic engineering or medi- cine—is a metabiological activity. Science, on the other hand, has the goal of understanding nature. The questions of science are why? and how? Those of engineering, in all of its thrusts, are how can we? Engineering achieves its goals through the design and operation of machines (arti- facts), be they tangible, such as a bridge or the modification of a gene or a hip replacement, or intangible, such as a computer program or a thera- peutic protocol. (I prefer the term ‘machine’ to artifact or device because in its Greek etymology—mechané—it also has a slightly pejorative conno- tation that fits our ambivalence about some impacts of technology.) In the traditional sense of the word—used henceforth in this paper unless otherwise noted—engineering is a specific method for designing machines. There are complex interactions among engineering, the physi- cal inanimate world, and the biological world that need to be identified as they are relevant to an understanding of where bioengineering and the ethical problems of bioengineering fit in the picture (Figure 1). Engineer- ing, as an agent modifying nature, interacts with the physical inanimate world, and as an agent to extend biology, it interacts with the biological world. The specific interaction of engineering with the biological world thus far has been recognized primarily as the domain of bioengineering, although it is clear that all of engineering is centrally involved, whether it recognizes it or not, in the modification of the biological world (for ex- ample, a highway, by bisecting a habitat, changes the biology of that habi- tat). It is also clear that any significant engineering development has an impact on society, just as any significant societal development ultimately is likely to lead to engineering developments. We may want to note at this point that not only the artifacts—the machines—that are created by engineering, but also society are metabiological activities. Both machines and society extend biology by other means as they interact with biological organisms and with each other. Traditionally, engineering has been focused on the outward exten- sion of biological organisms, that is, on extensions that are external to the

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44 THE EXPERIENCES AND CHALLENGES OF SCIENCE AND ETHICS Traditional Interactions Engineering Strong Weak Physical Engineering Inanimate Agent to Modify World FIGURE 1 The physical inanimate world, the biological world, engineering, and society—The complex interactions. organism—from buildings to space ships. Bioengineering, instead, has been concerned with the inward applications of engineering, that is, ap- plications focused on processes inside the biological organism. In the fu- ture, however, more and more the activities of engineering will blur the distinction between inward and outward processes. For example, biomimesis, with its goal of designing machines by drawing inspiration from biological processes and designs, is an extension from the organism outward. Simple examples of biomimesis are today’s artificial organs, as well as bio-electrical sensors, that is, biological sensors implanted on an electronic platform, or vice versa. Another future interaction between bio- logical organisms and engineering, the creation of bio-machines bringing together in intimate combination a biological organism and a machine, will further blur the separation between inward and outward thrusts of engineering with respect to biological organisms. Thus, bioengineering has multiple roles. It brings engineering to bear on medicine and on biological organisms. It brings a knowledge of biol- ogy to bear on engineering designs (biotechnology and biomimesis are the result of this direction). It creates a bio-machine synthesis. And, most importantly, it helps develop a metabiological view of engineering—a

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45 APPENDIX E new and powerfully productive way of assessing the meaning of engi- neering as the extender of biology. Engineering, historically and still today, is primarily an emanation of the physical sciences with which it constantly and closely interacts. More recently, starting primarily in the second half of the 20th century, engi- neering has been brought to bear on the biological sciences, spawning the field of bioengineering. Bioengineering thus sits astride engineering, bi- ology and medicine. In our endeavor to understand the nature and role of bioengineering, we need, furthermore, to take into account the physical sciences because of their close association with engineering. (Of course, the physical sciences also have directly intervened in the biological sci- ences, as in the case of biophysics and biochemistry.) An understanding of all these relationships becomes essential if we are to develop a clear picture of the challenges and meaning of ethics in bioengineering. Physics in particular, engineering, biology and medicine have both differences and commonalities with respect to the goals, domains, key challenges, instruments, and key philosophical and ethical issues that they address (Table 1). The goal of physics as a science is that of understanding nature, and so is that of biology, in the context of biological nature. On the other hand, the goal of engineering is to modify nature and that of medicine, like engineering, is also to modify nature, limitedly to biologi- cal nature—to heal disease, which is by and large a natural phenomenon. The nature of the goal of engineering and medicine is teleological, while that of physics and biology is not. The domain of physics is universal; that of biology is limited, of course, to biological organisms; that of medicine is limited primarily to humans and, in veterinary medicine, to higher ani- mals, while the domain of engineering is the potentially limitless one of machines and alterations of nature, from nanomachines to macroenvi- ronmental machines or processes such as dams, highways and weather modification. The key challenges today in physics are cosmogony and the develop- ment of a unified theory. In biology they are the origin of life, the evolu- tion of life forms, and complexity, including behavior and consciousness. The key challenge of engineering is the enhancement of humans through materials, energy, information and systems, as in biomimesis, but also, as in aeronautical engineering, the imitation of the capabilities of some life forms, like flight. The key challenge of medicine, of course, is under- standing the origins of disease and the prevention and cure of disease. The key instruments of both physics and biology are theory; those of medicine are diagnosis and therapy, which in turn is based on theories. The key instrument of engineering is design, which has a byproduct, theory. The key philosophical issues of physics are how do we know and how do we verify that knowledge—the matter-mind problem of what is knowledge in

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TABLE 1 Some Characteristics of Physics, Engineering, Biology and Medicine 46 Physics Engineering Biology Medicine Goal Understand nature Modify nature Understand nature Modify biological nature (heal) (biological) Nature of Goal Nonteological Teleological Nonteological Teleological Domain Universal Machines (from nano to Biological organisms Primarily humans and higher macroenvironmental) animals Key Challenges • Cosmogony • Enhancement of • Origins of life Prevention and treatment of • Unifying theory humans through • Evolution of life forms disease o Materials (including behavior) o Energy • Complexity (including o Information consciousness) o Systems • Imitation of life attributes Instruments Theories Design (byproduct: Theories • Diagnosis theories) • Therapy (based on theories) Key Philosophical • How do we know? • What is a machine? • What is life? Nature of disease Issues • Matter-mind problem • Why machines? • Body-mind problem • How far with machines? Key Ethical • Purpose of research • Purpose of machines • Purpose of research • Limits of therapy Issues • Impacts of research • Impacts of machines • Impacts of research • Informed consent • Limits of research (biosocial-environmental) • Limits of research • Individual versus societal • Limits to machines benefit THE EXPERIENCES AND CHALLENGES OF SCIENCE AND ETHICS • Safety • Risk and benefit xx

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47 APPENDIX E our mind and what is objectively outside knowledge. In biology, the key issues are the nature of life, and the body-mind problem of consciousness, which parallels the matter-mind problem of physics. In medicine, the key philosophical issue is the nature of disease, whereas in engineering, the issues are what is the machine? why do we have machines? and how far can we go with machines?—all issues very seldom discussed by engineers. The associated key ethical issues are shaped primarily, as is, in general, the case for all of ethics, by conflicts among contrasting views, needs, or actions. In physics and biology, these key issues are the purpose of research, and the impacts and limits of research as exemplified by the controversies about cloning and nuclear energy. In engineering, the key ethical issues have to do with the benefits—cui bonum?—of the machine, the biosocial and environmental impacts of the machines and with safety and permis- sible risk. In medicine, the issues concern the limits of therapy, again safety and risk, the Hippocratic imperatives, informed consent, and the role of the patient, as well as the dilemma of individual versus societal benefit. ETHICS IN BIOENGINEERING This very simplified overview of the fields that flow together to form the basis of bioengineering helps us identify some of the fundamental ethical issues in bioengineering. These are issues that concern, again, the domain and focus of bioengineering, the views of nature that govern the activities of bioengineering, the impacts of bioengineering, its limits, risks and safety factors, the question of activism, and that of intellectual re- sponsibility. Starting with the domain, a first issue is whether the ethical responsibility of bioengineering should be exclusively human-centric or could be extended to a broader bio-centric domain. The issue of animal experimentation, for instance, evolves around this question. Should bioengineers be concerned exclusively with the health of humans, or should they have a broader responsibility over all life forms? In terms of focus, a key ethical issue is prevention versus therapy. The escalation of medical costs makes it increasingly necessary to focus on prevention, yet historically most of the medically oriented activities of bioengineering have been focused on therapy, and on very costly devices. Another focus issue with ethical implications is medical versus industrial. Both medical and industrial activities are important to society, but when they are carried out side by side in a research laboratory, they sharply bring in focus the issue of disinterest versus vested interest—the disinter- est that should govern medical-oriented activity versus the vested interest which characterizes industrial activity and is a prime mover of industrial success. A third issue, in terms of focus, is that of the individual versus

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48 THE EXPERIENCES AND CHALLENGES OF SCIENCE AND ETHICS society. This is the dilemma, for medicine and bioengineering alike, that is at the core of today’s debate about health care—whether the focus should be exclusively on an individual or whether, or to what extent, the question of costs to society should also be taken into account. In terms of views of nature, how complex the ethical issues confronting bioengineering are can be underscored by the multitude of basic and of- ten conflicting values involved.4 These values range from utilitarian (em- phasis on the way in which humans derive benefits from nature) to the naturalistic (the satisfaction that people obtain from the direct experience of nature), from the ecological (the integrative nature of ecology) to the scientific (the relation of structure and processes), from the aesthetic (the aesthetic influence of nature and living diversity on humans) to the sym- bolic (the use of nature for communication of thought), to the doministic (the domination of nature), from the atavistic (the fear and aversion to the dangers of the natural world) to the humanistic (nature as a means to give people an avenue for attachment and bonding) and the moralistic (the basic component of nature as a source of spirituality and guidance for humans). Each of these values involves ethical dilemmas for bioengineer- ing, starting with basic biology versus engineering dilemma of whether to accept nature as is, or to modify it, as medicine and engineering do. The dilemma leads to different ethics—the ethics of discovery versus that of design—and to today’s debates about genetic engineering. In terms of impact, the technicalization of health care and the deper- sonalization today increasingly associated with it, particularly in ad- vanced economies, should also be areas of ethical concern for the bio- engineer, and so should the change of human outlook brought about by the possibility of artificial organs or genetic engineering. In terms of limits, a most important ethical issue for bioengineering is the positioning of the bio-machine interface. Where should the biological organism end and the machine begin? Where should the development of machines be positioned in that polarity between biological organisms and machines? Issues related to these are the limits of biomimesis, that is, how far should the bioengineer—and, more generally, the engineer—go with the imitation of biology in creating devices? As to bio-machines, should they still retain the essential characteristics of biological organ- isms or should they possess more those of machines? In terms of risk and safety factors, the ethical issues have to do with acceptable risks and appropriate safety factors. In bioengineering, these 4 Kellerp, Stephen R., The Value of Life: Biological Diversity in Human Society. Island Press: Washington, DC, 1996.

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49 APPENDIX E issues are an intriguing and difficult meeting point of the ethics of medi- cine, engineering, and biology. In terms of activism, the issue that all engineers encounter in our soci- ety is the extent to which, rather than merely executing the wishes of soci- ety, they should lead society in acquiring an understanding of future pos- sibilities and in moving in new directions. There are two different models. By and large, engineers have tended to see their role more as a purely technical one, while biologists and health professionals have been less timid in an independent leadership role. Which model should bioengineers adopt? Closely related to the question of activism is the ethical issue of the intellectual responsibility of the bioengineer, that is, whether and to what extent the bioengineer should intervene in the philo- sophical dialogue about the modification of nature and about the future of humans and their responsibility for other species. It is clear even from a cursory view of issues such as these, that the ethical questions involved in bioengineering are very broad and very fun- damental, and it is equally clear that, as of now, barely the surface of many of these questions has been addressed. ETHICAL TENETS FOR BIOENGINEERS In reviewing the immense challenges in the development of bioengi- neering ethics, it is tempting to suggest—very subjectively—some initial tenets for the bioengineer that may, if nothing else, open up a much needed dialogue on the issues: • the finality tenet: to expand the capabilities of biological organisms, individually and collectively. • the approval tenet: to understand and approve the goal of the medi- cal or industrial processes in which the bioengineer is involved. In other words, the engineers should not participate in a medical procedure or in the development of an industrial bioengineering process of which he or she does not approve, technically challenging as those processes or proce- dures may be. The bioengineer must exert his or her judgment. • the knowledge tenet: to base a design on a knowledge of nature and engineering as vast as possible. For instance, the knowledge on which bioengineering draws cannot be based only on a stereotyped view of hu- man nature as purely a rational one. It must take into account, as all engineering should, the emotional component of human nature. Neglect of that component has contributed to the cold impersonality of many health care institutions. • the value added tenet: to strive to add value to and through an object, a process, or a modification of nature.

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50 THE EXPERIENCES AND CHALLENGES OF SCIENCE AND ETHICS • the harm avoidance tenet (essentially a restatement of the Hippocratic belief): to avoid harming individuals, to minimize the side effects of a design, and not to design something that the bioengineer would not use on him or herself if necessary. • the risk tenet: to explicitly weigh risks to human society and envi- ronment of a bioengineering device or process. • the effectiveness tenet: to make cost and risk of a design or interven- tion commensurate with expected benefits. At times, the effort expended and the risks of a solution do not yield sufficient benefits to justify its development, yet the development is pursued, for a variety of reasons. • the simplicity tenet (an extension to bioengineering of Ockham’s ra- zor): to achieve a goal with means that are as simple as possible, so as to avoid excessively complicated and costly designs. • the conflict of interest tenet: not to advocate an unsafe, ineffective, or inferior design because of a vested interest in it. • the responsibility tenet: to assume the responsibility to follow up the performance of a design or process and communicate the results, positive or negative; to assume the responsibility for advocating the introduction of a beneficial design or process and the elimination of a dangerous one. • the professional tenet: to act as an independent-minded professional, regardless of whatever pressure may be put on a bioengineer by the envi- ronment (the hospital, the research laboratory, the factory) and to inter- vene in professional and public discussions about engineering, medical, biological, and societal issues. Much too often, bioengineers are silent on these issues. CONCLUSION The ethics of bioengineering is one of the most complex and challeng- ing of all ethics, as it must blend the ethics of engineering, biology, medi- cine, and the physical sciences. To the extent that it can do so, it brings bioengineering to the forefront of human endeavors, as an activity that synthesizes the two most exquisitely human activities—how to under- stand nature and how to modify it for an ever better future of our species.