Ethical Issues Associated with the Use of Medical Technology

Subrata Saha

Clemson University

Joseph D. Bronzino

Trinity College/Biomedical Engineering Alliance for Connecticut (BEACON)

Professional Ethics in Biomedical Engineering Daniel E. Wueste

A Variety of Norms Govern Human Contact • Professional Ethics and Ethics Plain and Simple • Professions • The Profession of Biomedical Engineering • Two Sources of Professional Ethics • Professional Ethics in Biomedical Engineering • Tools for Design and Decision in Professional Ethics • Professional Integrity, Responsibility, and Codes

Beneficence, Nonmaleficence, and Technological Progress Joseph D. Bronzino Defining Death: A Moral Dilemma Posed by Medical Technology • Euthanasia

Ethical Issues of Animal and Human Experimentation in the Development of Medical Devices Subrata Saha, Pamela S. Saha

Clinical Trials • Animal Experimentation

Regulation of Medical Device Innovation Joseph D. Bronzino

Ethical Issues in Feasibility Studies • Ethical Issues in Emergency Use • Ethical Issues in Treatment Use • The Safe Medical Devices Act

B

Iomedical engineering is responsible for many of the recent advances in modern medicine. These developments have led to new treatment modalities that have significantly improved not only medical care, but the quality of life for many patients in our society. However, along with such positive outcomes new ethical dilemmas and challenges have also emerged. These include: (1) involvement of humans in clinical research, (2) definition of death and the issue of euthanasia, (3) animal experi­mentation and human trials for new medical devices, (4) patient access to sophisticated and high cost medical technology, (5) regulation of new biomaterials and devices. With these issues in mind, this section discusses some of these topics. The first chapter focuses on the concept of professional ethics and its importance to the practicing biomedical engineer. The second chapter deals with the role medical technology has played in the definition of death and the dilemmas posed by advocates of euthanasia. The third chapter focuses on the use of animals and humans in research and clinical experimentation. The final chapter addresses the issue of regulating the use of devices, materials, etc. in the care of patients.

Since the space allocated in this Handbook is limited, a complete discussion of the many ethical dilemmas encountered by practicing biomedical engineers is beyond the scope of this section. Therefore, it is our sincere hope that the readers of this Handbook will further explore these ideas from other texts and articles, some of which are referenced at the end of the chapter. Clearly, a course on biomedical ethics should be an essential component of any bioengineering curriculum.

With new developments in biotechnology and genetic engineering, we need to ask ourselves not only if we can do it, but also “should it be done?” As professional engineers we also have an obligation to educate the public and other regulatory agencies regarding the social implications of such new develop­ments. It is our hope that the topics covered in this section can provide an impetus for further discussion of the ethical issues and challenges faced by the bioengineer during the course of his/her professional life.

Wueste, D. E. “Professional Ethics in Biomedical Engineering.” The Biomedical Engineering Handbook: Second Edition.

Ed. Joseph D. Bronzino

Boca Raton: CRC Press LLC, 2000

189

Professional Ethics in Biomedical Engineering

A Variety of Norms Govern Human Contact

Professional Ethics and Ethics Plain and Simple

Professions

The Profession of Biomedical Engineering

Two Sources of Professional Ethics

Professional Ethics in Biomedical Engineering

Tools for Design and Decision in Professional

Daniel E. Wueste Ethics

Clemson University 189.8 Professional Integrity, Responsibility, and Codes

A Variety of Norms Govern Human Conduct

Various norms or principles govern our activities. They guide us and provide standards for the evaluation of conduct. For example, our conduct is governed by legal and moral norms. These two sets of norms overlap, but it is clear that the overlap is not complete. Morality requires some acts that are not legally required of us and vice versa. Not surprisingly, then, we speak of legality and morality, of legal obligations and moral obligations. This is appropriate primarily because (1) law and morality are distinct sources of obligation and (2) it is possible for legal and moral obligations to conflict. Recognizing that moral and legal obligations have distinct sources, it is easier to appreciate the nature of a conflict between them and work toward its resolution. The same thing can be said within the sphere of morality. Moral rules and principles can and do give rise to conflicting obligations. Here too, the way people speak is revealing. People speak of professional obligations and social responsibilities, as well as the duties of “ordinary morality.” Such talk is increasingly heard in the high-tech fields of biomedicine and biomedical engi­neering, for here the development and use of sophisticated technology intersect with the rights and interests of human beings in an especially profound way.

Professional Ethics and Ethics Plain and Simple

Talk of professional ethics presupposes a distinction between the constraints that arise “from what it means to be a decent human being” (Camenisch, 1981) and those that come with one’s role or attach to the enterprise in which one is engaged. Paul Camenisch calls the former “ethics plain and simple.” The latter are the elements of an occupational or role morality. They only apply to persons who occupy a specific role. The idea here is simple enough. A father, for example, has responsibilities that a man who is not a father does not have. So too, a college teacher, a cleric, or a police officer has responsibilities that persons not occupying these roles do not have.

A professional ethic is an occupational or role morality. It is like the law in several ways. For example, it is not a mere restatement of the norms of ordinary morality. Another point of similarity is that like the law, its scope is limited; it has a jurisdiction in the sense that what it requires or permits is role specific. Thus, for example, the norms of the lawyer’s professional ethic do not impose obligations on people who are not lawyers. Still another similarity is that a professional ethic may allow (or even require) acts that ordinary morality disallows or condemns. An explanation of this fact begins with the observation that, in general, as professionals do their work they are allowed to put to one side considerations that would be relevant and perhaps decisive in the ethical deliberations of nonprofessionals. So, for instance, an attorney is free to plead the statute of limitations as a bar to a just claim against his/her client or to block the introduction of illegally seized evidence in a criminal trial even though his/her client committed the alleged offense. Now one thing that might be said here is that the attorney is simply doing his/her job. The point would be well taken. However, it leaves something rather important unsaid, namely, that the conduct in question is obligatory for the attorney.

Thinking along lines such as these is not confined to the paradigm professions of law and medicine. For example, scientists have been known to claim that as scientists they are free to (indeed must) put to one side social, political, and moral concerns about the uses to which their discoveries may be put. Indeed, some have claimed that scientists are morally obligated not to forgo inquiry even if what emerges from it can be put to immoral or horrendous uses. Plainly, such an appeal to a professional ethic can excite controversy. And this reveals another respect in which a professional ethic (role morality) is like law: it is subject to moral critique. Indeed, it is not only subject to moral criticism, its validity depends on its being morally justified (i. e., justified in terms of “ethics plain and simple”).

One important way in which a professional ethic differs from law is that it is widely held that its standards are in some sense higher than those of ordinary morality. More is expected of professionals than nonprofessionals. They are expected to act on the basis of the knowledge that sets them apart and in doing so they are expected to put the interests of clients or patients ahead of their own interests. Clearly, if professionals are governed by special, higher standards, if the rights and duties of professionals differ from the rights and duties of nonprofessionals, then it makes a difference whether one’s occupation counts as a profession.

Professions

As it happens, there is no generally accepted definition of the term “profession”. However, several writers have suggested that some characteristics common to recognized professions are necessary or essential. The idea that these writers share is that with these characteristics in mind one can mark a serviceable distinction between professional and nonprofessional occupations.

Bayles [1989] maintains that three features of a profession are necessary: (1) extensive training, (2) that involves a significant intellectual component, and (3) puts one in a position to provide an important service to society. To be sure, other features are common. For example: (1) the existence of a process of certification or licensing, (2) the existence of a professional organization, (3) monopoly control of tasks,

Self-regulation, and (5) autonomy in work. But, according to Bayles, they are not essential. The crucial point in the argument that they are not essential is that a large (and growing) number of professionals work in organizations (e. g., HMOs or institutions such as hospitals) where tasks are shared and activities are directed and controlled by superiors. Two things are noteworthy here. First, Bayles’s analysis does not include normative features among those that distinguish professions from non professions. Second, in his analysis an occupation may count as a profession though it lacks certain features common to most professions. While Bayles’s decision not to include normative features among the distinguishing features of professions has been criticized by several writers who insist that such features are indeed essential, the second point has met with widespread agreement.

It will be well to avoid the controversy respecting what is and what is not essential to a profession. Happily, a survey of the substantial literature on professions reveals agreement on several points that, taken together, provide a helpful picture of professions and professional activity. This picture is rather Like a sketch made by a police artist who works with descriptions provided by various witnesses. It has five elements. The first is the centrality of abstract, generalized, and systematic knowledge in the perfor­mance of occupational tasks. The second element is the social significance of the tasks the professional performs; professional activity promotes basic social values. The third element is the claim to be better situated/qualified than others to pronounce and act on certain matters. This claim reaches beyond the interests and affairs of clients. Professionals (experts) believe that they should define various aspects of society, life, and nature and we generally agree. For example, we defer to them (or at least our elected representatives do) in matters of public policy and national defense. Moreover, in certain settings, a hospital for example, it is simply impossible not to defer to the judgment of experts/professionals. The crucial premise can scarcely be doubted: in the contemporary world there is more to know (much of it having immediate practical application) than any one person is capable of knowing. The fourth point is that, on the basis of their expertise and the importance of the work that requires it, professionals claim that as practitioners they are governed by role-specific norms—a professional ethic—rather than the norms that govern human conduct in general. Now, it cannot be denied that particular applications of the relevant norms have been a source of controversy. However, since controversy of this sort generally presupposes the applicability and validity of the role-specific norms, it only serves to confirm the general point. The final element of the composite picture is that now most professionals work in bureaucratic organizations/institutions. The romantic appeal of the model of the professional as solo-practitioner may incline one to balk at this. But romance must not be allowed to prevail over evidence. And in this case the evidence is substantial. In fact, some of it is arresting. For example, it was recently reported that eighty percent of recent medical school graduates are salaried employees of HMOs, clinics, or hospitals (US News and World Report, 1999).

The Profession of Biomedical Engineering

As we have seen, it is not an idle question whether biomedical engineering is a profession. If professionals are governed by special, higher standards, if the rights and duties of professionals differ from the rights and duties of nonprofessionals, then it makes a difference whether one’s occupation counts as a profession.

Since there is no standard definition, no set of necessary and sufficient conditions the satisfaction of which would be decisive, in answering the question we will have to proceed in a different way. It is suggested that we think in terms of characteristics shared by recognized professions that, taken together, constitute a composite picture akin to what a police sketch artist might draw. What is seen when one looks at this picture? In particular, does the picture match the reality of biomedical engineering practice? Looking at this composite picture of a profession it is seen that (1) abstract, generalized, and systematic knowledge is crucial to the performance of occupational tasks (2) these tasks promote basic social values,

Practitioners claim to be better situated/qualified than others to pronounce and act on certain matters,

The conduct of practitioners is governed by role-specific norms, and (5) most of the work done by practitioners is done within bureaucratic institutions. The fit between the reality of biomedical engineer­ing practice and this composite picture of professions is tight. Indeed, looking to this picture to answer the question whether biomedical engineering is a profession, it can scarcely be doubted that the answer is yes.

One possible objection to this answer might be that there is no code of ethics for bioengineers, and thus bioengineering does not count as a profession because the fourth requirement is not satisfied. The objection could be met by pointing to a code for bioengineers, if there was one. But a better response is that the objection itself is misplaced. It is based on the mistaken assumption that there is a set of conditions the satisfaction of which is necessary and sufficient for the ascription of the term “profession” to an occupation. But the existence of a code of ethics is neither necessary nor sufficient for an occupation to count as a profession; what we are working with is a composite picture, not a definition. The objection is misplaced for a second reason as well. Even if there is no code of ethics for bioengineers, codes of ethics are well known in engineering. For example, the National Society of Professional Engineers and the Institute of Electrical and Electronic Engineers have codes of ethics. In addition, the National

Committee on Biomedical Engineering (Australia) has produced a set of professional standards. More­over, a professional ethic may develop by other than quasi-legislative means; in this respect it is like law which has both legislative and customary forms. Thus, there is nothing here to impugn the claim that bioengineering is a profession.

Two Sources of Professional Ethics

It is important to be clear about the fact that a professional ethic may develop in more than one way. A professional ethic is a role morality. The norms of a profession’s role morality need not be expressly “legislated” by, for example, a professional organization, because most of them are implicitly legislated in practice. Thus, one way to identify the norms of a profession’s role morality is to reflect on the expectations one has respecting the conduct of one’s peers. The stable interactional expectancies of practice can constitute what amounts to a customary morality of a profession, an uncodified professional ethic. To be sure, these customary norms may be codified (and often are). However, just as in the case of customary law, codification is not necessary for their validity. Indeed, it is entirely appropriate to say that codification of some such norms (like some laws) is the result of the codifier’s recognition of their independent validity.

It should be noted here that the norms of a customary morality are valid only if they are accepted in practice. It is important, however, that while acceptance is necessary, it is not sufficient. It cannot be sufficient, because if it were, the idea that something is right simply because someone or some group believes it is right would have to be granted. And that, of course, is patently false. What, then, are the additional conditions for the validity of such norms? This is surely a fair question. However, answering it completely would lead us far afield. Consequently, a short answer will have to suffice. The case for the validity of a norm of customary morality (in other words, for its status as a moral norm) turns on whether, in addition to being accepted in practice, compliance with it has good consequences and does not infringe upon the rights of other persons. It will be noticed that these are precisely the sorts of considerations that persons charged with the task of rule making do, or at any rate should, regard as decisive in doing their work. In any case, whether the norms of a professional ethic arise in practice or are expressly “legislated” by a group, they are “dual aspect norms” (Wellman, 1985). They are in play for role agents who are trying to decide what action to take; they are also in play for others within and outside of the profession who observe or by other means become aware of deviation from (or conformity to) them and react accordingly.

Professional Ethics in Biomedical Engineering

It is clear that biomedical engineering has an ethical dimension. After all, human well being is at stake in much if not most of what a biomedical engineer does. Indeed, error or negligence on the part of a biomedical engineer can result in unnecessary suffering or death. Of course, much the same can be said of other engineering fields. Yet, there is something distinctive here. The National Committee on Biomed­ical Engineering has identified three ways in which biomedical engineering differs from other branches of engineering. First, biomedical engineers work with biological materials that behave differently from and have different properties than the materials that most engineers work with. Second, preparation for a career as a biomedical engineer involves study of both engineering principles and the life sciences. Third, and most important for present purposes, is “the indirect and very often direct responsibility of biomedical engineers for their work with patients.” Such responsibility for the well-being of others is a clear indicator that a role has an ethical dimension.

Many things in biomedical engineering that fall under the rubric of professional ethics have to do with policies or procedures. For example, the development of

Methods for obtaining informed consent and criteria for justified departure from these methods,

Means for identifying subjects for clinical trials,

Criteria of thorough testing,

Standards to obviate or mitigate conflicts of interest, as well as mechanisms for their application and enforcement, and

Criteria for just distribution of scarce biomedical resources (expertise and technology).

AH of these things (in this far from exhaustive list) fall under the rubric of professional ethics. However, they are institutional in the sense that they call for decisions about policies or procedures rather than individual action. Decisions in these areas are not decisions to be made by individual practitioners nor are they decisions to be taken case by case. They are decisions about structures of practice that require quasi-legislative activity. Relying on others with requisite expertise, and soliciting input from persons whose interests are at stake in biomedical engineering practices, biomedical engineers should work to develop structures of practice that satisfy legal requirements and ensure, as far as possible, that their professional practice manifests a commitment to safety and the promotion of human well-being. These carefully designed structures of practice should be part of the explicitly quasi-legislated portion of the professional ethic of biomedical engineering.

The question that arises naturally here is how to proceed in this undertaking. Precisely which of the dominant approaches in ethics—utilitarian, deontological, or aretaic—is best is a subject of vigorous debate among philosophers. But this issue will not be debated here. Instead, a sketch will be presented of an approach that can be employed in designing ethical structures of practice, and then, with one difference to be explained, used in making individual ethical decisions in one’s capacity as a professional.

Tools for Design and Decision in Professional Ethics

Multiple analyses or several independent judges are often relied on in making decisions. In general, this is done when something significant turns on the final decision. For example, physicians frequently call for a consultation and patients are encouraged to seek a second opinion before an invasive procedure is performed. Similarly, hospitals and universities rely on panels or commissions—an Institutional Review Board, for example—to make decisions about proposed research or other pressing issues. In such cases it is assumed, rightly, that relying on multiple modes of analysis or several judges is wise even though (1) they produce the same judgment in many—hopefully most—cases and, thus, appear to involve redundancy; and (2) in some cases they produce conflict that could have been avoided by relying on a single mode of analysis or single judge. Why is this a wise course? One part of the answer is that our confidence is bolstered when the same conclusion is reached by different trustworthy means or judges. Here redundancy is a value. The second part of the answer is that being open to conflicting opinions and analyses can help us to avoid errors that would occur otherwise. This will happen when the conflict prompts reexamination of the question that reveals facts previously overlooked or undervalued or mistaken analyses. It should be noted that the approach recommended here is not political; logical and evidentiary considerations rather than simple consensus justify the judgments it produces. Randy Barnett sums up the case for such an approach:

The virtue of adopting multiple or redundant modes of analysis is… twofold: (a) convergence (or agreement) among them supports greater confidence in our conclusions; and (b) divergence (or conflict) signals the need to critically reexamine the issue in a search for reconciliation. In sum, convergence begets confidence, divergence stimulates discovery. [Barnett, 1990]

In the context of professional ethics an approach of this sort would involve reliance on three modes of analysis: (1) utilitarian, (2) rights-based deontological, and (3) role-based institutional. A brief descrip­tion of each mode of analysis is presented in the following paragraphs.

A utilitarian analysis begins with the assumption that rightness is a function of value and tells us that what is morally required of us is the production of the greatest amount of good possible in a situation for all of the affected parties. Utilitarian thinking leads quite directly to an embrace of the familiar principles of nonmaleficence and beneficence. Deontological analysis denies the essential connection between rightness and goodness asserted by utilitarianism. Unlike utilitarians, deontologists hold that some actions are intrinsically right and some actions are intrinsically wrong. More particularly, they insist that the fact that the consequences of an action are the best possible in a given situation does not show that the action is right. The most famous of deontological theories, that of Immanuel Kant, teaches that what is morally required of us is that wherever found, in ourselves or others, humanity is always treated as an end and never as a mere means to an end. In other words, persons have intrinsic worth (as Kant said, they have a dignity rather than a price) and must never be treated as if their value were merely instrumental (as if they were things). That is our duty; the other side of that coin is the right others have to receive that sort of treatment from us. What matters on this approach, then, is whether one is treating people as they deserve to be treated. Thus, deontological thinking leads directly to an embrace of the familiar principles of autonomy and justice. These two modes of analysis are alike in this: both proclaim independence from what the commonly accepted ideas regarding right and wrong are in a community; on both views morality is not something that is instituted (made); rather, it is discovered (not by empirical investigation, but by ratiocination). Thus, these modes of analysis contrast sharply with the third mode of analysis to be discussed here, namely, the role-based institutional mode.

Thinking in terms of role morality rightness is a function of conformity with the stable interactional expectations—accepted norms of conduct—associated with a role. Responsibilities and rights are tied to the function of a role agent within an institution. A role morality is institutional in the quite basic sense that it is instituted, that is, brought into existence by human beings. Sometimes, of course, this is accomplished by quasi-legislative means. But such activity is neither necessary nor the most common means of creation. A role morality is implicit in practice, it is established through mutually beneficial interaction over time. It is a customary or conventional morality. (There is an analogy here to the law in its customary and legislative forms.) One final point, noted earlier, is that considerations of non — institutional morality play a critical role in the validation of the norms of a role morality. The familiar maxim in medicine, primum non nocere, as well as the implicit rule of lawmaking that lawmakers must promulgate the laws they make (no secret laws), are examples of principles that would be readily embraced by those thinking along these lines and validated by considerations of non-institutional morality.

We can summarize this brief description of the three modes of analysis in the following way. The key question for the utilitarian is one of maximal value; for the rights-based deontological thinker it is one of deserved or rightful treatment; with role morality it is one of conformity to established custom or practice.

The recommended approach for the design of ethical structures of practice is to use all three modes of analysis. The hope is that they will converge on the same result. When they do we can be confident that implementation of the principle or policy is justifiable. That is the case, for example, with the rules of professional practice requiring fidelity, confidentiality, privacy, and veracity.

Using this approach one hopes for convergence on the same result. That is to be expected in easy cases. But not all cases are easy cases. Our analyses may diverge rather than converge. What then? Barnett suggests that divergence “stimulates discovery.” The idea is that achieving convergence may be difficult, but at least sometimes it may be achieved on a second pass by retracing one’s steps—going through the analyses again, paying special attention to the input—or rethinking the analyses themselves, paying special attention to previously identified sources of difficulty. For example, utilitarian and deontological analyses may diverge because they deal with individual rights in different ways. Deontologists treat rights as trumps; utilitarians simply include them among the considerations that count in their calculations respecting likely consequences. It may be that the two modes of analysis diverge because of an erroneous assignment of weight to the rights that are in play. If so, convergence can be achieved by rethinking the weight assigned to the rights in the utilitarian calculations. It must be admitted, however, that divergence may not be eliminated by such means. What then? In anticipation of such cases, a presumption should be made in favor of one of the modes of analysis.

When one’s project is the design of ethical structures of practice, the presumption should be made in favor of rights-based deontological analysis, it being understood that utilitarian considerations may rebut the presumption favoring rights in some circumstances. When one’s project is not the design of decision Devices (structures of practice), but deciding what one ought to do as a professional, a presumption should be made in favor of institutional responsibilities, i. e., professional ethics, it being understood that utilitarian or deontological considerations may rebut the presumption in favor of role responsibilities under some circumstances. The point of this presumption is that the burden of justification is properly placed on those who would depart from valid norms. Two things argue in favor of this: (1) a presumption in favor of institutional responsibilities (professional ethics) presupposes a justification of the sort pro­vided by the convergence of the three modes of analysis and (2) making this presumption guards against the dangers of failing to take the professional ethic seriously and robbing the earlier work—constructing ethical structures of practice—of its point.

Professional Integrity, Responsibility, and Codes

Professional ethics involves more than merely complying with the norms of a code of ethics. This is true for several reasons, not the least of which is that there may not be a code. But even if there is a code, for example, the NSPE code, or the code of the AMA or ABA, there is still much more to professional ethics than compliance with the norms of that code. The rules and principles of a code set out the criteria for distinguishing malpractice from minimally acceptable practice. They do not reach to, nor do they define responsible practice. Indeed, they cannot do this, for responsible practice is more than doing one’s duty (thus we speak of responsibilities rather than duties); responsible practice involves discretion and judg­ment in an essential way. Moreover, it involves the integration of professional judgment (expertise) and moral judgment [Whitbeck, 1998]. Here the boundaries between fact and value are fluid or at any rate they vary much as boundaries marked by a river, the course of which changes over time.

It is perhaps best to conceive professional ethics as a call for responsible conduct on the part of practitioners. The call is justified because the integrity of individual practitioners is required for the integrity of a profession, which, in turn, is necessary to justify the trust of others essential to the success of professional practice in any area. There is much work to be done in making clear what the demands of responsible practice are and in maintaining integrity in practice (which is produced by adherence to the standards of responsible practice). There is no ethical algorithm; responsible judgment and action are essential in the development, interpretation, and application of the normative principles governing the profession of biomedical engineering.

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Ed. Joseph D. Bronzino

Boca Raton: CRC Press LLC, 2000

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