This thesis addresses the tension in pragmatic cluster-randomized trials between their social value and the requirement to respect the autonomy of research participants. Pragmatic trials are designed to evaluate the effectiveness of treatments in real-world settings to inform clinical decision-making and promote cost-efficient care. These trials are often embedded into clinical settings and ideally include all patients who would receive the treatments under investigation as a part of routine care. Trialists increasingly adopt cluster-randomized designs—in which intact groups, such as hospitals (...) or clinics, are allocated randomly to study interventions—to simplify the inclusion of all patients. But including all-comers conflicts with the requirement to obtain written informed consent from research participants. Since informed consent is central to respecting patient autonomy, the question arises: how can the ends of autonomy and pragmatism be served simultaneously? Some philosophers argue that patients have an obligation to participate in clinical research and that this may negate consent requirements. I argue that while there may be grounds for a prima facie obligation for patients to participate in clinical research, no compelling argument has demonstrated that the obligation is enforceable. Others assert that broad application of a waiver of consent will facilitate the conduct of pragmatic cluster-randomized trials. I demonstrate that this proposal sharply conflicts with the historical origins of the waiver. I articulate a novel moral foundation for the use of a waiver of consent and show that when trials evaluate treatments delivered directly to patients, the autonomy interests at stake for participants are too substantial to permit its use. My solution draws a distinction between consent requirements in existing policy and consent as an autonomous authorization. As many pragmatic cluster-randomized trials are conducted in primary care settings with no research staff, I argue that patient autonomy can be promoted and protected using clinical-style consent, in which health providers seek verbal informed consent from patients and document it in the electronic health record. This approach has been associated with high rates of recruitment and, thus, may satisfy both requirements for social value and respect for autonomy. (shrink)

The aim of this article is to review the recent popularity of casuistry as a model of moral inquiry. I argue that proponents of casuistry do not endorse the particularist epistemology that seems to be implied by their position, and that this is why casuistry does not seem to present something really new in comparison to 'top-down' generalist approaches. I contend that casuistry should develop itself as a (moderately) particularist position and that the challenge for the defender of casuistry is (...) to come up with ideas that strengthen the ('intuitionist') model of rationality that underlies most forms of particularism. (shrink)

Various theories have been put forward in an attempt to explain what makes moral judgments justifiable. One of the main theories currently advocated in bioethics is a form of coherentism known as wide reflective equilibrium. In this paper, I argue that wide reflective equilibrium is not a satisfactory approach for justifying moral beliefs and propositions. A long-standing theoretical problem for reflective equilibrium has not been adequately resolved, and, as a result, the main arguments for wide reflective equilibrium are unsuccessful. Moreover, (...) practical problems that arise in using the method of wide reflective equilibrium undermine the idea that it is a viable approach for justifying moral judgments about cases and policies. Given that wide reflective equilibrium is the most prominent version of coherentism, these considerations call into question the coherentist approach to justification in bioethics. (shrink)

This essay concerns itself with the methodology of practical ethics. There are a variety of methods employed in ethics. Although none have been firmly established as dominant, it is generally agreed that casuistry, or the case-based method, is one important strategy commonly used for resolving ethical issues. Casuists compare the case under consideration to a relevantly similar precedent case in which judgements have already been made, and they use these earlier judgements to determine the proper resolution of the present case. (...) In this article, I try to provide a better understanding of the nature of contemporary casuistry. To accomplish this, I explain the basic features of casuistic reasoning. The second section focuses on the logic of casuistry. By assessing casuistic reasoning from the logical viewpoint, casuistry can be reconstructed as a logically correct method of reasoning. The third section looks at casuistry from the epistemic point of view and investigates the justificatory force of casuistic reasoning. Finally, in the fourth section, I show the usefulness of formal casuistry. (shrink)

Specification is an integral part of Tom L Beauchamp and James F Childress' principlist approach to biomedical ethics. At the same time, the authors give much space conceding to critics that the method has significant limits. Although their pointing to limitations is not unreasonable as such, the emphasis Beauchamp and Childress put on them does not serve countering the critics' view that specification is insufficient for its intended purpose in applied ethics. This paper defends specification against Carson Strong's critique, showing (...) that his casuistic approach shares strong structural and functional similarities with specification. It concludes with the more general point that specification or some closely related method for determining morally relevant facts of concrete cases and issues is indispensable for any account of applied ethics. Beauchamp and Childress should endorse and defend specification more vigorously than they appear to do. (shrink)

BackgroundThis study presents an empirical investigation of the ethical reasoning and ethical issues at stake in the daily work of physicians and molecular biologists in Denmark. The aim of this study was to test empirically whether there is a difference in ethical considerations and principles between Danish physicians and Danish molecular biologists, and whether the bioethical principles of the American bioethicists Tom L. Beauchamp and James F. Childress are applicable to these groups.MethodThis study is based on 12 semi-structured interviews with (...) three groups of respondents: a group of oncology physicians working in a clinic at a public hospital and two groups of molecular biologists conducting basic research, one group employed at a public university and the other in a private biopharmaceutical company.ResultsIn this sample, the authors found that oncology physicians and molecular biologists employed in a private biopharmaceutical company have the specific principle of beneficence in mind in their daily work. Both groups are motivated to help sick patients. According to the study, molecular biologists explicitly consider nonmaleficence in relation to the environment, the researchers' own health, and animal models; and only implicitly in relation to patients or human subjects. In contrast, considerations of nonmaleficence by oncology physicians relate to patients or human subjects. Physicians and molecular biologists both consider the principle of respect for autonomy as a negative obligation in the sense that informed consent of patients should be respected. However, in contrast to molecular biologists, physicians experience the principle of respect for autonomy as a positive obligation as the physician, in dialogue with the patient, offers a medical prognosis based upon the patients wishes and ideas, mutual understanding, and respect. Finally, this study discloses utilitarian characteristics in the overall conception of justice as conceived by oncology physicians and molecular biologists from the private biopharmaceutical company. Molecular biologists employed at a public university are, in this study, concerned with allocation, however, they do not propose a specific theory of justice.ConclusionThis study demonstrates that each of the four bioethical principles of the American bioethicists Tom L. Beauchamp & James F. Childress – respect for autonomy, beneficence, nonmaleficence and justice – are reflected in the daily work of physicians and molecular biologists in Denmark. Consequently, these principles are applicable in the Danish biomedical setting. (shrink)

For nearly two decades, the process of reviewing the ethical merit of research involving human subjects has been based on the application of principles initially described in the U.S. National Commission's Belmont Report, and later articulated more fully by Beauchamp and Childress in their Principles of Biomedical Ethics. Recently, the use of ethical principles for deliberating about moral problems in medicine and research, referred to in the pejorative sense as “principlism”, has come under scrutiny. In this paper we argue that (...) these principles can provide a foundation for the source of ethical appraisal of human research, but are not themselves wholly adequate for this purpose. Therefore, we further propose that (1) principles should be understood as heuristics that can be “specified” as described by DeGrazia (1992), and (2) that the principle‐based approach should be supplemented by formally incorporating “sensitivity to context” into the evaluation of clinical trials. (shrink)

In recent years the literature on bioethics has begun to pose the sociological challenge of how to explore organisational processes that facilitate a systemic response to ethical concerns. The present discussion seeks to make a contribution to this important new direction in ethical research by presenting findings from an Australian pilot study. The research was initiated by the Clinical Ethics Committee of Redland Hospital at Bayside Health Service District in Queensland, Australia, and explores health professionals’ understanding of the nature of (...) ethics and their experience with ethical decision-making within an acute medical ward. This study focuses on the actual experience, understanding and attitudes of clinical professionals in a general medical ward. In particular, the discussion explores the specific findings from the study concerned with how a multi-disciplinary team of health professionals define and operationalise the notion of ethics in an acute ward hospital setting. The key issue reported is that health professionals are not only able to clearly articulate notions of ethics, but that the notions expressed by a multi-disciplinary diversity of participants share a common definitional concept of ethics as patient-centred care. The central finding is that all professional groups indicated that there is a guiding principle to address their ethical sense of the ‘good’ or the ‘ought’ and that is to act in a way that furthered the interests of patients and their families. The findings affirm the importance of a sociological perspective as a productive new direction in bioethical research. (shrink)

This article presents the findings of qualitative research which explored, from the mothers’ perspective, the process of decision-making about mode of delivery for a subsequent birth after a previous Caesarean Section. In contradiction to the clinical literature, the majority of mothers in this study were strongly of the opinion that a vaginal birth after caesarean (VBAC) posed a higher risk than an elective caesarean (EC). From the mothers’ perspective, risk discussions were primarily valuable for gaining support for their pre-determined choice, (...) rather than obtaining information. The findings posit ethical concerns with regards to informed consent and professional obstetric practice at a time when there is a documented and worrying trend towards an increase in births by caesarean section (CS). (shrink)

There have been many attempts during the history of applied ethics that have tried to develop a theory of moral reasoning. The goal of this paper is to explicate one aspect of the debate between various attempts of offering a specific method for resolving moral dilemmas. We contrast two kinds of deliberative methods: deliberative methods whose goal is decision-making and deliberative methods that are aimed at gaining edifying perspectives. The decision-making methods assessed include the traditional moral theories like utilitarianism and (...) Kantianism, as well as second order principles, such as principlism and specified principlism. In light of this assessment, we suggest taking a closer look at two perceptive models, casuistry and particularism. These models are used for dealing with moral dilemmas that provide for edifying perspectives rather than decision-making. These perceptive models, though less scientific and not as good at prescribing an action, are more human in the sense that they enrich our moral sensibilities and enhance our understanding of the meaning of the situation. (shrink)

For over 100 years, the field of contemporary public health has existed to improve the health of communities and populations. As public health practitioners conduct their work – be it focused on preventing transmission of infectious diseases, or prevention of injury, or prevention of and cures for chronic conditions – ethical dimensions arise. Borrowing heavily from the ethical tools developed for research ethics and bioethics, the nascent field of public health ethics soon began to feel the limits of the clinical (...) model and began creating different frameworks to guide its ethical challenges. Several public health ethics frameworks have been introduced since the late 1990s, ranging from extensions of principle-based models to human rights and social justice perspectives to those based on political philosophy. None has coalesced as the framework of choice in the discipline of public health. This paper examines several of the most-known frameworks of public health ethics for their common theoretical underpinnings and values, and suggests next steps toward the formulation of a single framework. (shrink)

Public health ethics is a nascent field, emerging over the past decade as an applied field merging concepts of clinical and research ethics. Because the “patient” in public health is the population rather than the individual, existing principles might be weighted differently, or there might be different ethical principles to consider. This paper reviewed the evolution of public health ethics, the use of bioethics as its model, and the proposed frameworks for public health ethics through 2010. Review of 13 major (...) public health ethics frameworks published over the past 15 years yields a wide variety of theoretical approaches, some similar foundational values, and a few similar operating principles. Coming to a consensus on the reach, purpose, and ends of public health is necessary if we are to agree on what ethical underpinnings drive us, what foundational values bring us to these underpinnings, and what operating principles practitioners must implement to make ethical decisions. If public health is distinct enough from clinical medicine to warrant its own set of ethical and philosophical underpinnings, then a decision must be made as to whether a single approach is warranted or we can tolerate a variety of equal but different perspectives. (shrink)

In this paper I critically examine the implications of the uncodifiability thesis for principlism as a pluralistic and non-absolute generalist ethical theory. In this regard, I begin with a brief overview of W.D. Ross’s ethical theory and his focus on general but defeasible prima facie principles before turning to 2) the revival of principlism in contemporary bioethics through the influential work of Tom Beauchamp and James Childress; 3) the widespread adoption of specification as a response to the indeterminacy of abstract (...) general principles and the limitations of balancing and deductive approaches; 4) the challenges raised to fully specified principlism by the uncodifiability thesis and 5) finally offer a defense of the uncodifiability thesis against various critiques that have been raised. (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)

Moral decision procedures such as principlism or casuistry require intuition at certain junctures, as when a principle seems indeterminate, or principles conflict, or we wonder which paradigm case is most relevantly similar to the instant case. However, intuitions are widely thought to lack epistemic justification, and many ethicists urge that such decision procedures dispense with intuition in favor of forms of reasoning that provide discursive justification. I argue that discursive justification does not eliminate or minimize the need for intuition, or (...) constrain our intuitions. However, this is not a problem, for intuitions can be justified in easy or obvious cases, and decision procedures should be understood as heuristic devices for reaching judgments about harder cases that approximate the justified intuitions we would have about cases under ideal conditions, where hard cases become easy. Similarly, the forms of reasoning which provide discursive justification help decision procedures perform this heuristic function not by avoiding intuition, but by making such heuristics more accurate. Nonetheless, it is possible to demand too much justification; many clinical ethicists lack the time and philosophical training to reach the more elaborate levels of discursive justification. We should keep moral decision procedures simple and user-friendly so that they will provide what justification can be achieved under clinical conditions, rather than trying to maximize our epistemic justification out of an overstated concern about intuition. (shrink)

Promoting patient autonomy has become a key imperative in health service encounters. We will examine the potential negative effects of over-promoting patient autonomy and consider the impact on patient access, their experience and the provision of equitable services by focusing on an extreme manifestation of this trend, i.e. calls for patient involvement in health care decision making to be mandatory. Advocates of mandatory autonomy hold that patients have a duty to themselves, to society and to the medical system to make (...) decisions on their health care independently. Models of mandatory autonomy may be contrasted to those of optional autonomy that seek to ascertain patients’ decisional preferences and to understand wider limitations on their freedom to choose. Where choice as decisional responsibility becomes mandatory it ceases to promote agency and where autonomous choice is understood as an individualistic practice it will contribute to the cultural dominance of Western values. Moreover, taking a view that principlist ethics needs to take account of the social and cultural contexts of individual lives, we argue that if mandatory autonomy were to be over-emphasised as part of an ongoing move towards patient choice in UK National Health Service (NHS), educated and affluent people would be more able to exercise choices at the expense of people who are experienced in asserting preferences and who have the resources to make use of choices. We will argue that the promotion of autonomy needs to be tempered by steps to enable less powerful social, cultural and economic groups to contribute to decision making and to support individuals who may feel abandoned by having decisional responsibility transferred to them. Until constraints on individual choice can be understood and addressed, we advocate the model of optional autonomy used in shared decision making and make recommendations for practice, policy, education and research. (shrink)

This paper is the result of a contribution between ethics and law, which will be used as thought-process tools, to address the complex issue of legal and ethical statuses of GM fish. To find answers, we propose to consider this issue from a wider angle, looking at the relations between the human, animal, and living worlds. We show that it is possible to construct other forms of intellectual logic that, without setting these worlds in opposition, do not lapse into relativism (...) where boundaries are blurred. In this sense, we submit the hypothesis that ordered pluralism should help us to move past a mere Man–Animal relationship to reveal the entire complexity of relationships within mankind and between mankind and other (non-human) worlds alongside it and to which it belongs: the animal and living worlds. With this new logic, “animal ethics” and “animal law” are re-embedded into a set of relationships. This logic emerges from a new consideration: the nature of the contemporary objects we are dealing with. We shall call objects like genetically modified fish “relational objects” in the sense that in order to be apprehended, they utilize a set of relationships of which there are just as many as the dimensions forming them, not as predicates but as primary constituents. Experimentally, in the case of GM fish, we translate this by proposing to typologize legal and ethical considerations induced by multiple relations connected to this object. According to the type of relationship in question, the GM fish will not have the same status; it is a changing object that must be suitably apprehended. (shrink)

This article is an attempt to understand ethical theory not just as a set of well-developed philosophical perspectives but as a range of moral capacities that human beings more or less grow into over the course of their lives. To this end, we explore the connection between formal ethical theories and stage developmental psychologies, showing how individuals mature morally, regarding their duties, responsibilities, ideals, goals, values, and interests. The primary method is to extract from the writings of Kohlberg and his (...) students the cues that help to flesh out a developmental picture of a wide range of ethical perspectives. Thus, developmental psychology benefits from gaining a broader understanding of “morality” and “ethics,” and ethical theory benefits from a richer understanding of how moral maturity arises from youthful beginnings in juvenile and adolescent thinking. Results of this study offer insight into the difficulty of teaching ethics and a refined ability to assess moral maturity in business activity. (shrink)

Research in nanotechnology has advanced rapidly in recent years. Several researchers, however, warn that there is a paucity of research on the ethical, legal, and social implications of nanotechnology, and they caution that ethical reflections on nanotechnology lag behind this fast developing science. In this article, the authors question this conclusion, pointing out that the predicted concrete ethical issues related to the area of nanotechnology are rather similar to those related to the area of biotechnology and biology that have been (...) considered by ethicists since the 1970s. Hence, a knowledge base has already been acquired from ethical reflections on biotechnology and biology, which may be a good starting point and foundation for a discussion of ethical reflections on nanotechnology. The authors argue that a promising approach is the use of basic ethical principles as a method to analyze ethical issues of nanotechnology. (shrink)

This article provides a critical comparative analysis of the substantive and procedural values and ethical concepts articulated in guidelines for allocating scarce resources in the COVID-19 pandemic. We identified 21 local and national guidelines written in English, Spanish, German and French; applicable to specific and identifiable jurisdictions; and providing guidance to clinicians for decision making when allocating critical care resources during the COVID-19 pandemic. US guidelines were not included, as these had recently been reviewed elsewhere. Information was extracted from each (...) guideline on: 1) the development process; 2) the presence and nature of ethical, medical and social criteria for allocating critical care resources; and 3) the membership of and decision-making procedure of any triage committees. Results of our analysis show the majority appealed primarily to consequentialist reasoning in making allocation decisions, tempered by a largely pluralistic approach to other substantive and procedural values and ethical concepts. Medical and social criteria included medical need, co-morbidities, prognosis, age, disability and other factors, with a focus on seemingly objective medical criteria. There was little or no guidance on how to reconcile competing criteria, and little attention to internal contradictions within individual guidelines. Our analysis reveals the challenges in developing sound ethical guidance for allocating scarce medical resources, highlighting problems in operationalising ethical concepts and principles, divergence between guidelines, unresolved contradictions within the same guideline, and use of naïve objectivism in employing widely used medical criteria for allocating ICU resources. (shrink)

AbstractThe Belmont Report continues to be held in high regard, and most bioethical analyses conducted in recent years have presumed that it affects United States federal regulations. However, the assessments of the report’s creators are sharply divided. Understanding the historic reputation of this monumental report is thus crucial. We first recount the historical context surrounding the creation of this report. Subsequently, we review the process involved in developing ethical guidelines and describe the report’s features. Additionally, we analyze the effect of (...) unfolding events on the subsequent creation of federal regulations, especially on gene therapy clinical trials. Moreover, throughout this paper we evaluate the ethical principles outlined in this report and describe how they overlap with the issue of protecting socially vulnerable groups. Based on the analysis, we conclude that the features of the Belmont Report cannot be considered as having affected the basic sections of the federal regulations for ethical reviews that were made uniform in 1981. Nevertheless, regarding the regulations on gene therapy clinical trials—which were at first expected to be applicable to research involving children—in addition to implementing policies regarding the public review of protocols that passed ethical review, this report’s principles are clearly reflected in the key notes that should have been referred to when the report was created. (shrink)

This paper discusses the importance of Richard M. Zaners work on clinical ethics for answering the question: what kind of doing is ethics consultation? The paper argues first, that four common approaches to clinical ethics – applied ethics, casuistry, principlism, and conflict resolution – cannot adequately address the nature of the activity that makes up clinical ethics; second, that understanding the practical character of clinical ethics is critically important for the field; and third, that the practice of clinical ethics is (...) bound up with the normative commitments of medicine as a therapeutic enterprise. (shrink)

Within this thesis, I argue for an interpretive approach to bioethics in pediatric intensive care. I begin by outlining the dominant bioethical doctrine that defines standards for ethical care in critically ill children. I critique this doctrine as legalistic and acultural. Drawing largely on the ideas of Charles Taylor, I call for a reconception of bioethics and propose an interpretive framework that is centred on culture and context. Finally, I illustrate this interpretive approach through a comparative study of two cases (...) in pediatric intensive care: the narratives of Marc and Larry. (shrink)