How can we draw the line between health and disease? This crucial question of demarcation has immense practical implications and has troubled scholars for ages. The question will be addressed in three steps. First, I will present an important contribution by Rogers and Walker who argue forcefully that no line can be drawn between health and disease. However, a closer analysis of their argument reveals that a line-drawing problem for disease-related features does not necessarily imply a line-drawing problem for disease (...) as such. The second step analyzes some alternative approaches to drawing the line between health and disease. While these approaches do not provide full answers to the question, they indicate that the line-drawing question should not be dismissed too hastily. The third step investigates whether the line-drawing problem can find its solution in the concept of suffering. In particular, I investigate whether returning to the origin of medicine, with the primary and ultimate goal of reducing suffering, may provide sources of demarcation between health and disease. In fact, the reason why we pay attention to particular phenomena as characteristics of disease, consider certain processes to be relevant, and specific functions are classified as dys-functions, is that they are related to suffering. Accordingly, using suffering as a criterion of demarcation between health and disease may hinder a wide range of challenges with modern medicine, such as unwarranted expansion of disease, overdiagnosis, overtreatment, and medicalization. (shrink)

This chapter explores the foundation and content of the duty to respect persons. The authors argue that it is best understood as a duty to recognize people’s rights. Respect for persons therefore has specific implications for how competent and non-competent persons ought to be treated in research. For competent persons it underlies the obligation to obtain consent to many research procedures. The chapter gives an analysis of the requirements for obtaining valid consent. It then considers respect for persons as it (...) relates to four common topics: the therapeutic misconception, research with children and adolescents, the use of deception in research, and research on competent adults without their consent. (shrink)

Over the last few decades, multiple studies have examined the understanding of participants in clinical research. They show variable and often poor understanding of key elements of disclosure, such as expected risks and the experimental nature of treatments. Did the participants in these studies give valid consent? According to the standard view of informed consent they did not. The standard view holds that the recipient of consent has a duty to disclose certain information to the profferer of consent because valid (...) consent requires that information to be understood. The contents of the understanding and disclosure requirements are therefore conceptually linked. In this paper, we argue that the standard view is mistaken. The disclosure and understanding requirements have distinct grounds tied to two different ways in which a token of consent can be rendered invalid. Analysis of these grounds allows us to derive the contents of the two requirements. It also implies that it is sometimes permissible to enroll willing participants who have not understood everything that they ought to be told about their clinical trials. (shrink)

Although advance directives are widely believed to be a key way to safeguard the autonomy of incompetent medical patients, significant questions exist about their moral authority. The main philosophical concern involves cases in which an incompetent patient no longer possesses the desires on which her advance directive was based. The question is, does that entail that prior expressions of medical choices are no longer morally binding? I believe that the answer is “yes.” I argue that a patient’s autonomy is not (...) respected by honoring the desires she used to have but no longer does. I also consider and reject the view that honoring an advance directive that reflects the patient’s previous values must be in that patient’s best interests. If that is correct, then advance directives in the kind of case at issue are not morally binding. (shrink)

Similarly to other accounts of disease, Christopher Boorse’s Biostatistical Theory (BST) is generally presented and considered as conceptual analysis, that is, as making claims about the meaning of currently used concepts. But conceptual analysis has been convincingly critiqued as relying on problematic assumptions about the existence, meaning, and use of concepts. Because of these problems, accounts of disease and health should be evaluated not as claims about current meaning, I argue, but instead as proposals about how to define and use (...) these terms in the future, a methodology suggested by Quine and Carnap. I begin this article by describing problems with conceptual analysis and advantages of “philosophical explication,” my favored approach. I then describe two attacks on the BST that also question the entire project of defining “disease.” Finally, I defend the BST as a philosophical explication by showing how it could define useful terms for medical science and ethics. (shrink)

This paper addresses the question of what value pluralism tells us about the pursuit of moral coherence as a method of moral reasoning. I focus on the status of the norm of ‘systematicity,’ or the demand that our principles be as few and as simple as possible. I argue that, given certain descriptive facts about the pluralistic ways we value, epistemic ways of supporting a systematicity norm do not succeed. Because it is sometimes suggested that coherence functions in moral reasoning (...) as it does in scientific reasoning, my argument considers analogies and disanalogies between moral reasoning and scientific reasoning. (shrink)

Participants in some clinical trials are at risk of being harmed and sometimes are seriously harmed as a result of not being provided with available, relevant risk information. We argue that this situation is unacceptable and that there is a moral duty to disclose all adverse clinical trial results to participants in clinical trials. This duty is grounded in the human right not to be placed at risk of harm without informed consent. We consider objections to disclosure grounded in considerations (...) of commercial interest, and we argue that these concerns are insufficient to override the moral duty to disclose adverse clinical trial results. However, we also develop a proposal that enables commercial interests to be protected, while promoting the duty to disclose adverse clinical trial results. (shrink)

In order to protect patients against medical paternalism, patients have been granted the right to respect of their autonomy. This right is operationalized first and foremost through the phenomenon of informed consent. If the patient withholds consent, medical treatment, including life-saving treatment, may not be provided. However, there is one proviso: The patient must be competent to realize his autonomy and reach a decision about his own care that reflects that autonomy. Since one of the most important patient rights hinges (...) on the patient's competence, it is crucially important that patient decision making incompetence is clearly defined and can be diagnosed with the greatest possible degree of sensitivity and, even more important, specificity. Unfortunately, the reality is quite different. There is little consensus in the scientific literature and even less among clinicians and in the law as to what competence exactly means, let alone how it can be diagnosed reliably. And yet, patients are deemed incompetent on a daily basis, losing the right to respect of their autonomy. In this article, we set out to fill that hiatus by beginning at the very beginning, the literal meaning of the term competence. We suggest a generic definition of competence and derive four necessary conditions of competence. We then transpose this definition to the health care context and discuss patient decision making competence. (shrink)

Accounts of the concepts of function and dysfunction have not adequately explained what factors determine the line between low‐normal function and dysfunction. I call the challenge of doing so the line‐drawing problem. Previous approaches emphasize facts involving the action of natural selection (Wakefield 1992a, 1999a, 1999b) or the statistical distribution of levels of functioning in the current population (Boorse 1977, 1997). I point out limitations of these two approaches and present a solution to the line‐drawing problem that builds on the (...) second one. (shrink)

In professional settings, people often have diverse and competing conceptions of responsibility and of when it is fair to hold someone responsible. This may lead to undesirable gaps in the distribution of responsibilities. In this paper, a procedural model is developed for alleviating the tension between diverging responsibility conceptions. The model is based on the Rawlsian approach of wide reflective equilibrium and overlapping consensus. The model is applied to a technological project, which concerned the development of an in-house monitoring system (...) based on ambient technology. The development of this innovative technology raised questions among the technological researchers about its social acceptance and the way issues related to privacy and security should be addressed. The case is analyzed in terms of two procedural norms (reflective learning and inclusiveness), which are based on literature on policy and innovation networks. Analysis of the case shows that, in a pluralist setting, a procedural approach can be useful for encouraging discussion on the legitimacy of different responsibility conceptions and the question what a fair responsibility distribution amounts to. (shrink)

In this commentary, I critically discuss the respective views of Gert and Beauchamp–Childress on the nature of so-called common morality and its promise for enriching ethical reflection within the field of bioethics. Although I endorse Beauchamp and Childress’ shift from an emphasis on ethical theory as the source of moral norms to an emphasis on common morality, I question whether rouging up common morality to make it look like some sort of ultimate and universal foundation for morality, untouched by the (...) dialectics of time and reflective equilibrium, was an equally good move. As for Gert’s magisterial conception of common morality, I conclude that certain elements of his system are controversial at best and woefully inadequate at worst. He has a tendency to find in common morality what he himself put there, and his highly restricted conception of duties of assistance strikes this reader as ad hoc, inadequately defended, and unworthy of a project whose goal is to lessen the amount of misery in the world. (shrink)

Contemporary research ethics policies started with reflection on the atrocities perpetrated upoconcentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim of (...) this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

The vagueness or imprecision of ‘the normal’ allows it to be exploited for various purposes and political ends. It is conspicuous in both medicine and athletics; I am going to try to say something about the normal in each of these areas. In medicine the idea of the normal is often deployed in understanding what constitutes disease and hence, as some see it, in determining the role of physicians, in determining what is or ought to be covered by insurance, and (...) in underwriting certain views on social justice. In athletics the use of performance enhancing substances raises different sorts of questions about the normal, especially when it comes to deciding what constitutes an enhancement and which enhancements, if any, are acceptable. (shrink)

The emergence of global bioethics is connected to a rise of interest in ethics in general (both in academia and in the public sphere), combined with an increasing awareness of the interrelatedness of peoples and their ethical dilemmas, and the recognition that global problems need global solutions. In short, global bioethics has two distinguishing features: first, its global scope, both geographically and conceptually; and second, its focus on justice (communal and individual).

Definition of the problem: Is respect for autonomy in medicine synonymous with respect for autonomous choices? Does it depend on the competency of patients? Arguments: The article criticizes this opinion, which is widely held in the field of medical ethics. This position does not recognize the problem of paternalism in its full import in modern medicine. It misunderstands the moral meaning of autonomy in its primacy over the psychological meaning, as well as the close ties between autonomy and beneficence. These (...) ties are made evident by reflection on basic anthropological conditions of ethics. Conclusion: Proceeding from this reflection I outline consequences for the praxis of non- paternalistic care that also respects the will of non-competent patients. (shrink)

The last twenty-five years of published literature and curriculum development in bioethics suggest that the field enjoys a successful and stable marriage to philosophical ethical theory. However, the next twenty-five years could be very different. I believe the marriage is troubled. Divorce is conceivable and perhaps likely. The most philosophical parts of bioethics may retreat to philosophy departments, while bioethics continues on its current course toward a more interdisciplinary and practical field.I make no presumption that bioethics is integrally linked to (...) philosophical ethical theory. Indeed, I assume that the connection is contingent and fragile. Many individuals in law, theological ethics, political theory, the social and behavioral sciences, and the health professions carefully address mainstream issues of bioethics without finding ethical theory essential or breathtakingly attractive. This is not surprising. Moral philosophers have traditionally formulated theories of the right, the good, and the virtuous in the most general terms. (shrink)

Ethicists widely accept the notion that scientists have moral responsibilities to benefit society at large. The dissemination of scientific information to the public and its political representatives is central to many of the ways in which scientists serve society. Unfortunately, the task of providing information can often give rise to moral quandaries when scientific experts participate in politically charged debates over issues that are fraught with uncertainty. This paper develops a theoretical framework for an “ethics of expertise” (EOE) based on (...) the notion that scientists have responsibilities to provide information in a way that promotes autonomous decision-making on the part of the public and its representatives. Moreover, insofar as the principle of informed consent has developed in biomedical ethics as a way for physicians to promote autonomous decision-making on the part of their patients, this paper suggests that the informed-consent concept may suggest a set of criteria and guidelines that can help scientists to fulfill their similar ethical responsibilities to the public. In order to illustrate how the resulting EOE could provide practical guidance for scientific experts, the paper examines a case study involving the dissemination of information about the low-dose biological effects of toxic chemicals and carcinogens. (shrink)

Approaches to clinical ethics dilemmas that rely on basic principles or rules are difficult to apply because of vagueness and conflict among basic values. In response, casuistry rejects the use of basic values, and specification produces a large set of specified rules that are presumably easily applicable. Balancing is a method employed to weigh the relative importance of different and conflicting values in application. We argue against casuistry and specification, claiming that balancing is superior partly because it most clearly exhibits (...) the reasoning behind moral decision-making. Hence, balancing may be most effective in teaching bioethics to medical professionals. (shrink)

Standard views on surrogate decision making present alternative ideal models of what ideal surrogates should consider in rendering a decision. They do not, however, explain the physician''s responsibility to a patient who lacks decisional capacity or how a physician should regard surrogates and surrogate decisions. The authors argue that it is critical to recognize the moral difference between a patient''s decisions and a surrogate''s and the professional responsibilities implied by that distinction. In every case involving a patient who lacks decisional (...) capacity, physicians and the treatment team have to make judgments about the appropriateness of both the surrogate and the surrogate''s decision. They have to assess the surrogate''s decisional capacity and attitude toward the patient as well as the reasons that support the surrogate''s decision. This paper provides a model for acceptable surrogate decisions and a standard for blocking inappropriate surrogates. Only decisions based on widely shared reasons are allowable for surrogate refusal of highly beneficial treatment. (shrink)

Health policy frameworks usually construe environmental protection and human health as harmonious values. Policies that protect the environment, such as pollution control and pesticide regulation, also benefit human health. In recent years, however, it has become apparent that promoting human health sometimes undermines environmental protection. Some actions, policies, or technologies that reduce human morbidity, mortality, and disease can have detrimental effects on the environment. Since human health and environmental protection are sometimes at odds, political leaders, citizens, and government officials need (...) a way to mediate and resolve conflicts between these values. Unfortunately, few approaches to applied bioethics have the conceptual tools to do accomplish this task. Theories of health care ethics have little to say about the environment, and theories of environmental ethics don’t say much about human health. In this essay, I defend an approach to ethical decision-making that gives policy-makers some tools for balancing promotion of human health and protection of the environment. (shrink)

Background Best interests is a ubiquitous principle in medical policy and practice, informing the treatment of both children and adults. Yet theory underlying the concept of best interests is unclear and rarely articulated. This paper examines bioethical literature for theoretical accounts of best interests to gain a better sense of the meanings and underlying philosophy that structure understandings. Methods A scoping review of was undertaken. Following a literature search, 57 sources were selected and analysed using the thematic method. Results Three (...) themes emerged. The first placed best interests within the structure of wider theory, noting relationships with consequentialism, deontology, prudential value theory, rights and political philosophy. The second mapped a typology of processes of decision-making, among which best interests was ambiguously positioned. It further indicated factors that informed best interests decision-making, primarily preferences, dignity and quality of life. The final theme considered best interests from a relational perspective. Conclusions Characterisation of best interests as strictly paternalist and consequentialist is questionable: while accounts often suggested a consequentialist basis for best interests, arguments appeared philosophically weak. Deontological accounts, found in law and Kantianism, and theories of political liberalism influenced accounts of best interests, with accounts often associating best interests with negative patient preferences (i.e. individual refusals). There was much more emphasis on negative interests than positive interests. Besides preference, factors like dignity and quality of life were held to inform best interests decisions, but generally were weakly defined. To the extent that preferences were unable to inform decision making, decisions were either made by proxy authority or by an intersubjective process of diffuse authority. Differing approaches reflect bifurcations in liberal philosophy between new liberalism and neo-liberalism. Although neither account of authority appears dominant, bias to negative interests suggests that bioethical debate tends to reflect the widespread ascendancy of neo-liberalism. This attitude was underscored by the way relational accounts converged on private familial authority. The visible connections to theory suggest that best interests is underpinned by socio-political trends that may set up frictions with practice. How practice negotiates these frictions remains a key question. (shrink)

In celebration of the fortieth anniversary of the publication of Beauchamp and Childress’s Principles of Biomedical Ethics, a review is undertaken to compare the lists of principles in various bioethical theories to determine the extent to which the various lists can be reconciled. Included are the single principle theories of utilitarianism, libertarianism, Hippocratism, and the theories of Pellegrino, Engelhardt, The Belmont Report, Beauchamp and Childress, Ross, Veatch, and Gert. We find theories all offering lists of principles numbering from one to (...) ten. Many of the differences can be reconciled, but some critical differences remain. (shrink)

Contemporary research ethics policies started with reflection on the atrocities perpetrated upon concentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim (...) of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

The multidisciplinary provenance of bioethics leads to a variety of discursive styles and ways of reasoning, making the discipline vulnerable to criticism and unwieldy to the setting of solid theoretical foundations. Applied ethics belongs to a group of disciplines that resort to deliberation rather than formal argumentation, therefore employing both factual and value propositions, as well as emotions, intuitions and other non logical elements. Deliberation is thus enriched to the point where ethical discourse becomes substantial rather than purely analytical. Caution (...) must be exercised to avoid this formal permissiveness from accepting empty and incorrigible statements that are but flatus voci since they can neither be supported nor falsified. It is therefore suggested that deliberation in bioethics should comply with three sets of conditions: (1) Be understandable, truthful, honest and pertinent, as suggested by communicative ethics; (2) Allow for second order, thick judgements as suggested by pragmatism; (3) Abide by additional criteria as here proposed: Doxastic propositions should be bolstered by a cognitive element; statements should be specific and proportional to the issue at hand, and they should be arguable and coherent. (shrink)

Definition of the problem: Contemporary bioethics as an academic discipline mainly focuses on moral questions – according to its articulated self-concept and the explicit arguments in most areas of bioethical reflection. Concepts and theories of the good life are hardly considered. Arguments: In reality the ‘good life’ plays a much more important role than it is assumed, but mostly only in an implicit way. The article demonstrates this by referencing three selected fields of bioethical discussion. Hence the article argues that (...) bioethics should turn the ‘good life’ into an issue of intense, explicit and systematic consideration. Furthermore, the article provides an initial answer to the questions as to why the ‘good life’ has been marginalized within bioethics up to this point and which function it can assume in future bioethical reflection. Conclusion: The ‘good life’ is the blind spot of bioethics. A more intensive and systematic consideration of the ‘good life’ is a challenge for contemporary and future bioethics. (shrink)

A standard view in ethics is that ethical issues concern a different range of human concerns than does politics. This essay goes beyond the long-standing dispute about the extent to which applied ethics needs a commitment to ethical theory. It argues that regardless of the outcome of that dispute, applied ethics, because it presumes something about the nature of authority, rests upon and is implicated in political theory. After internalist and externalist accounts of applied ethics are described, “mixed” approaches are (...) considered that contain inevitable political dimensions. A feminist alternative, Walker’s metaethic of responsibility, shows that authority is best understood as relational and that situations of unequal power are therefore often the places where applied ethics arises. Furthermore, in a democratic society, commitments to democracy should shape the account of authority, and, thus, the nature of applied ethics as well. (shrink)

Some defenders of the view that there is a common morality have conceived such morality as being universal, in the sense of extending across all cultures and times. Those who deny the existence of such a common morality often argue that the universality claim is implausible. Defense of common morality must take account of the distinction between descriptive and normative claims that there is a common morality. This essay considers these claims separately and identifies the nature of the arguments for (...) each claim. It argues that the claim that there is a universal common morality in the descriptive sense has not been successfully defended to date. It maintains that the claim that there is a common morality in the normative sense need not be understood as universalist. This paper advocates the concept of group specific common morality, including country-specific versions. It suggests that both the descriptive and the normative claims that there are country-specific common moralities are plausible, and that a country-specific normative common morality could provide the basis for a country's bioethics. (shrink)

Although some regulatory frameworks for the occupational health and safety of nanotechnology workers have been developed, worker safety and health issues in these laboratory environments have received less attention than many other areas of nanotechnology regulation. In addition, workers in nanotechnology labs are likely to face unknown risks and hazards because few of the guidelines and rules for worker safety are mandatory. In this article, we provide an overview of the current health and safety guidelines for nanotechnology laboratory workers by (...) exploring guidelines from different organizations, including the Department of Energy Nanoscale Science Research Centers, Massachusetts Institute of Technology, the National Institutes of Health, the National Institute for Occupational Safety and Health, the Occupational Safety and Health Administration, Texas A&M University, and University of Massachusetts-Lowell. After discussing these current guidelines, we apply an ethical framework to each set of guidelines to explore any gaps that might exist in them. By conducting this gap analysis, we are able to highlight some of the weaknesses that might be important for future policy development in this area. We conclude by outlining how future guidelines might address some of these gaps, specifically the issue of workers’ participation in the process of establishing safety measures and the development and enforcement of more unified guidelines. (shrink)

From the first initiatives in preimplantation genetic diagnosis and gene therapy through the advent of stem cell research to the development of mammalian cloning, the past two decades have witnessed remarkable advances in “reprogenetic” medicine: the union of assisted reproductive technologies with genetic control. This period has also been marked by intense debates within the bioethical literature and in national policy forums about the appropriate uses of these emerging human capabilities. We can now, in a limited way, select for genetic (...) traits, and the power to modify the genome or introduce new gene sequences is not far off. How should these new powers be used? (shrink)

Rapid advances in neuroscience may enable us to identify the neural correlates of ordinary decision making. Such knowledge opens up the possibility of acquiring highly accurate information about people’s competence to consent to medical procedures and to participate in medical research. Currently we are unable to determine competence to consent with accuracy and we make a number of unrealistic practical assumptions to deal with our ignorance. Here I argue that if we are able to detect competence to consent and if (...) we are able to develop a reliable neural test of competence to consent, then these assumptions will have to be rejected. I also consider and reject three lines of argument that might be developed by a defender of the status quo in order to protect our current practices regarding judgments of competence in the face of the availability of information about the neural correlates of ordinary human decision making. (shrink)

(2001). Family Physicians and the Family Covenant Model's Usefulness in Solving Genetic Testing Conflicts. The American Journal of Bioethics: Vol. 1, No. 3, pp. 28-29.

Der Beitrag beschäftigt sich mit der Frage, ob eine Behinderung immer als Form von Leid betrachtet werden muss. Mit Hilfe einer Unterscheidung zwischen absoluten und komparativen Einschränkungen des Wohls wird aufgezeigt, dass die bloße Tatsache einer vorliegenden medizinischen Schädigung nicht hinreicht, ein Urteil über das absolute Wohl einer Person zu treffen. Es werden verschiedene Argumente geprüft, warum Behinderung dennoch generell negativ bewertet werden sollte. Diese werden zurückgewiesen. Abschließend wird eine Überlegung eingeführt, wonach gleichwohl bestimmte Formen der Behinderung als objektive Beeinträchtigungen (...) des Wohls zu gelten haben, nämlich dann, wenn basale Fähigkeiten betroffen sind. (shrink)

“Wicked” problems are characterized by intractable complexity, uncertainty, and conflict between individuals or institutions, and they inhabit almost every corner of medical ethics. Despite wide acceptance of the same ethical principles, we nevertheless disagree about how to formulate such problems, how to solve them, what would _count_ as solving them, or even what the possible solutions _are_. That is, we don’t always know how best to implement ethical ideals in messy real-world contexts. I sketch an implementation framework for medical ethics (...) that can help clarify wicked problems and organize further ethics research toward their resolutions. This framework describes the procedural variables that work alongside substantive ethical ideals to deliver ethical decisions in complex real-world situations. Using controversial GM mosquito research as an example, I illustrate how the generalizable relationships between the variables clarify emerging ethical guidelines of research governance and provide a pathway to extend these guidelines in a way consistent with our ethical intuitions across a wide range of research and public health ethics. (shrink)

Individuals each have their own unique conceptions of what is good. Nevertheless, because human beings have common needs, there is a significant overlap in their appreciation of what counts as good...

In this article I explore the underlying political philosophy of public bioethics by comparing it to technocratic authority, particularly the technocratic authority claimed by economists in Mexico in the 1980s and 1990s. I find that public bioethics - at least in the dominant forms - is implicitly designed for and tries to use technocratic authority. I examine how this type of bioethics emerged and has continued. I finish by arguing that, as claims to technocratic authority go, bioethics is in an (...) incredibly weak position, which partly explains why it has never gained the degree of public legitimacy that other technocracies have gained. I conclude by arguing for a "technocracy-lite" orientation for public bioethics. (shrink)