In this article I propose to reframe debates about ideals of emotion in medicine, abandoning the current binary setup of this debate as one between ‘clinical detachment’ and empathy. Inspired by observations from my own field work and drawing on Sky Gross’ anthropological work on rituals of practice as well as Henri Lefebvre’s notion of rhythm, I propose that the normative drive of clinical practice can be better understood through the notion of attunement. In this framework individual (...) types of emotions are not, as such, appropriate or inappropriate, but are evaluated depending on their synchronicity with the specific rhythms of the practice. To set up this proposal, I show how typical arguments about emotions in medicine—what I call emotion-entity focused frameworks—are insufficient. I then draw on ethnographic observations from two orthopaedic departments and interviews with medical practitioners to show (1) how clinical practice is driven by rhythmicity, shaped in the case of orthopaedic surgery by a clinical aim of efficient, controlled intervention, and (2) how clinicians continuously refer to this drive and the flow of rhythms when evaluating inappropriate or problematic emotion. I argue that the use of a rhythm framework rather than ideals of detachment or empathy allows for a sensitivity to the complexity and situation-dependent elements of emotional ideals in clinical practice; and I end by proposing the term ‘attuned concern’—which stresses the importance of regulation and adjustment to circumstances rather than of maintaining a constant distance/involvement—as a more fitting alternative to ‘clinical detachment’. (shrink)

Abstract: In this article, we explore what are ethical forms of holding service users responsible in mental health care contexts. Hanna Pickard has provided an account of how service users should be held responsible for morally wrong or seriously harmful conduct within contexts of mental health care, called the clinical stance. From a clinical stance one holds a person responsible for harm, but refrains from emotionally blaming the person and only considers the person responsible for this conduct in (...) a detached sense. Her account is based on what are considered best practices in the treatment of people with borderline personality disorder and addiction. We ask if this account generalizes across different diagnostic criteria and different clinical contexts. To begin to answer this question, we compare the clinical stance to an account of what are considered best practices in the treatment of service users at a specialized clinic for people with autism spectrum disorder in the Netherlands. We refer to this alternative account as the nurturing stance and highlight relevant similarities and differences between the clinical stance and the nurturing stance. We conclude with suggestions for further research and theorizing. (shrink)

Digital records, from chat transcripts to social media posts, are being used to create chatbots that recreate the conversational style of deceased individuals. Some maintain that this is merely a new form of digital memorial, while others argue that they pose a variety of moral hazards. To resolve this, I turn to classical Chinese philosophy to make use of a debate over the ethics of funerals and mourning. This ancient argument includes much of interest for the contemporary issue at hand, (...) including the use of impersonators of the dead to help the bereaved to deal well with their grief. I connect this historical discussion with a modern trend in clinical psychology that reframes therapeutic interventions with bereaved individuals. The trend directs practitioners away from facilitating detachment and toward affirming continuing bonds. I conclude that these chatbots can offer an important source of support to mourners, but also discuss parameters and features of social context that will be important to avoid the moral hazards identified by sceptics. (shrink)

In this article, we explicate evidence-based nursing (EBN), critically appraise its framework and respond to nurses’ concern that EBN sidelines the caring elements of nursing practice. We use resources from care ethics, especially Vrinda Dalmiya’s work that considers care as crucial for both epistemology and ethics, to show how EBN is compatible with, and indeed can be enhanced by, the caring aspects of nursing practice. We demonstrate that caring can act as a bridge between ‘external’ evidence and the other pillars (...) of the EBN framework: clinical expertise; patient preferences and values. Drawing on an influential EBN handbook, section 1 presents the aims and features of EBN, including the normative principle that EBN should take place within a ‘context of caring’. We aim to understand this context and whether it can be neatly detached from the EBN framework, as the handbook seems to suggest. In section 2, we highlight the grounds for resistance to EBN from the nursing community, before mounting the argument that nursing practices can be understood fruitfully through feminist care ethics and/or virtue ethics lenses. In section 3, we deepen that analysis using Dalmiya’s concepts of care-knowing and care as a hybrid ethico-epistemic virtue, which are ideally suited to the complex practices of nursing. In section 4, we bring this rich understanding of care into conversation with EBN, showing that its framework cannot be adequately theorised without paying proper attention to care. Caring can be neither an innocuous background assumption of nor an afterthought to the EBN framework. (shrink)

Decision-making has traditionally been viewed as detached from the neural systems of sensory perception and motor function. Consequently, motor areas have played a relatively minor role in discussions surrounding the control processes and neural origins of decision-making. Empiric evidence, catalysed by technological advances in the past two decades, has proven that motor areas have an integral role in decision-making. They are involved in the generation, modulation, maintenance and execution of decisions and actions. They also take part in a complex hierarchical (...) assessment of multi-modal inputs to ensure that the most appropriate action is generated given the context presented. Clinical conditions such as, alien hand syndrome and utilisation behaviour exemplify the importance of these regulatory controls. This review charts the trajectory of our understanding of the hidden role of motor areas in decision-making and reflects upon the implications of our deepened understanding. The convergence of evidence from multiple modalities underpinning our current knowledge is discussed and the potential applications thereof considered. (shrink)

The International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) COVID-19 dataset is one of the largest international databases of prospectively collected clinical data on people hospitalized with COVID-19. This dataset was compiled during the COVID-19 pandemic by a network of hospitals that collect data using the ISARIC-World Health Organization Clinical Characterization Protocol and data tools. The database includes data from more than 705,000 patients, collected in more than 60 countries and 1,500 centres worldwide. Patient data are available (...) from acute hospital admissions with COVID-19 and outpatient follow-ups. The data include signs and symptoms, pre-existing comorbidities, vital signs, chronic and acute treatments, complications, dates of hospitalization and discharge, mortality, viral strains, vaccination status, and other data. Here, we present the dataset characteristics, explain its architecture and how to gain access, and provide tools to facilitate its use. (shrink)

In this paper I will give an analysis of what I call ‘generalizing detached self-reference’ within a general account of reference to the first person. With generalizing detached self-reference an agent attributes properties to a range of individuals by putting himself into their shoes, or simulating them. I will show that generalizing detached self-reference plays an important role in the semantics of natural language, in particular in the English generic one and in what syntacticians call arbitrary PRO.

This article investigates a central yet perplexing term yiming in the ‘Qiwulun’ chapter of the Zhuangzi. Yiming describes a crucial way to detach from epistemic distinctions and debates. This term is often explained as ‘using ming’ or contradictorily as ‘stopping ming’. Yet neither of the two explanations can provide a full understanding of how yiming is adopted. I take three steps to explain yiming. First, taking an etymological approach, I argue that ming can be formulated as ‘X shining on Y’. (...) Second, I use the formula of ‘X shining on Y’ to account for yiming and argue that this term refers specifically to ‘using tian to shine on everything’. Third, I unpack a cluster of tian-associated metaphors, which provides a deep understanding of yiming as an ideal way to mental tranquility. (shrink)

The principle of clinical equipoise has been variously characterized by ethicists and clinicians as fundamentally flawed, a myth, and even a moral balm. Yet, the principle continues to be treated as the de facto gold standard for conducting randomized control trials in an ethical manner. Why do we hold on to clinical equipoise, despite its shortcomings being widely known and well-advertised? This paper reviews the most important arguments criticizing clinical equipoise as well as what the most prominent (...) proposed alternatives are. In the process, it evaluates the justification for continuing to use clinical equipoise as the gold standard for randomized control trials. (shrink)

Psychiatry has witnessed a new wave of approaches to clinical phenotyping and the study of psychopathology, including the National Institute of Mental Health’s Research Domain Criteria, clinical staging, network approaches, the Hierarchical Taxonomy of Psychopathology, and the general psychopathology factor, as well as a revival of interest in phenomenological psychopathology. The question naturally emerges as to what the relationship between these new approaches is – are they mutually exclusive, competing approaches, or can they be integrated in some way (...) and used to enrich each other? In this opinion piece, we propose a possible integration between clinical staging and phenomenological psychopathology. Domains identified in phenomenological psychopathology, such as selfhood, embodiment, affectivity, etc., can be overlaid on clinical stages in order to enrich and deepen the phenotypes captured in clinical staging (‘high resolution’ clinical phenotypes). This approach may be useful both ideographically and nomothetically, in that it could complement diagnosis, enrich clinical formulation, and inform treatment of individual patients, as well as help guide aetiological, prediction, and treatment research. The overlaying of phenomenological domains on clinical stages may require that these domains are reformulated in dimensional rather than categorial terms. This integrative project requires assessment tools, some of which are already available, that are sensitive and thorough enough to pick up on the range of relevant psychopathology. The proposed approach offers opportunities for mutual enrichment: clinical staging may be enriched by introducing greater depth to phenotypes; phenomenological psychopathology may be enriched by introducing stages of severity and disorder progression to phenomenological analysis. (shrink)

The development of artificial womb technology is proceeding rapidly and will present important ethical and theological challenges for Christians. While there has been extensive secular discourse on artificial wombs in recent years, there has been little Christian engagement with this topic. There are broadly two primary uses of artificial womb technology—ectogestation as a form of enhanced neonatal care, where some of the gestation period takes place in an artificial womb, and ectogenesis, where the entire gestation period is within an artificial (...) womb. Ectogestation for the latter weeks or months of pregnancy could be possible within a decade or so, while ectogenesis for humans is far more speculative. Ectogestation is likely to significantly decrease maternal and neonatal morbidity and mortality, and so there is a strong case for supporting its development. Ectogenesis, however, may bring a number of challenges, including the commodification of children, and the pathologizing of pregnancy and childbirth. Its long-term effects on those who are created through this process are also unknown. In the event that it becomes ubiquitous, we may also find the central theological significance of pregnancy and birth diminished. The dilemma for Christians is that the development of ectogestation seems likely to normalise the use of artificial gestation, and, in time, pave the way for ectogenesis. (shrink)

Clinical guidelines are special types of plans realized by collective agents. We provide an ontological theory of such plans that is designed to support the construction of a framework in which guideline-based information systems can be employed in the management of workflow in health care organizations. The framework we propose allows us to represent in formal terms how clinical guidelines are realized through the actions of are realized through the actions of individuals organized into teams. We provide various (...) levels of implementation representing different levels of conformity on the part of health care organizations. Implementations built in conformity with our framework are marked by two dimensions of flexibility that are designed to make them more likely to be accepted by health care professionals than standard guideline-based management systems. They do justice to the fact 1) that responsibilities within a health care organization are widely shared, and 2) that health care professionals may on different occasions be non-compliant with guidelines for a variety of well justified reasons. The advantage of the framework lies in its built-in flexibility, its sensitivity to clinical context, and its ability to use inference tools based on a robust ontology. One disadvantage lies in its complicated implementation. (shrink)

Clinical Ethics Consultations are an important tool for physicians in solving difficult cases. They are extremely common in North America and to a lesser extent also present in Europe. However, there is little data on this practice in Poland. We present results of a survey of 521 physicians practising in Poland concerning their opinion on CECs and related practices. We analysed the data looking at such issues as CECs’ perceived availability, use of CECs, and perceived usefulness of such support. (...) Physicians in our study generally encounter hard ethics cases, even—surprisingly—those who do not work in hospitals. Most physicians have no CEC access, and those that do still do not employ CECs. However, physicians perceive this form of support as useful—even more so among actual users of CECs. We compared these findings with similar studies from other European countries and the North America. We point out peculiarities of our results as compared to those in other countries, with some possible explanations. We hope the results may encourage regulatory debate on the need to formally introduce CECs into the Polish healthcare system. (shrink)

We argue that charging people to participate in research is likely to undermine the fundamental ethical bases of clinical research, especially the principles of social value, scientific validity, and fair subject selection.

Outcomes research in healthcare has been a topic much addressed in recent years. Efforts in this direction have been supplemented by work in the areas of guidelines for clinical practice and computer-interpretable workflow and careflow models.In what follows we present the outlines of a framework for understanding the relations between organizations, guidelines, individual patients and patient-related functions. The derived framework provides a means to extract the knowledge contained in the guideline text at different granularities, in ways that can help (...) us to assign tasks within the healthcare organization and to assess clinical performance in realizing the guideline. It does this in a way that preserves the flexibility of the organization in the adoption of the guidelines. (shrink)

The desideratum of semantic interoperability has been intensively discussed in medical informatics circles in recent years. Originally, experts assumed that this issue could be sufficiently addressed by insisting simply on the application of shared clinical terminologies or clinical information models. However, the use of the term ‘ontology’ has been steadily increasing more recently. We discuss criteria for distinguishing clinical ontologies from clinical terminologies and information models. Then, we briefly present the role clinical ontologies play in (...) two multicentric research projects. Finally, we discuss the interactions between these different kinds of knowledge representation artifacts and the stakeholders involved in developing interoperational real-world clinical applications. We provide ontology engineering examples from two EU-funded projects. (shrink)

Innovative practice occurs when a clinician provides something new, untested, or nonstandard to a patient in the course of clinical care, rather than as part of a research study. Commentators have noted that patients engaged in innovative practice are at significant risk of suffering harm, exploitation, or autonomy violations. By creating a pathway for harmful or nonbeneficial interventions to spread within medical practice without being subjected to rigorous scientific evaluation, innovative practice poses similar risks to the wider community of (...) patients and society as a whole. Given these concerns, how should we control and oversee innovative practice, and in particular, how should we coordinate innovative practice and clinical research? In this article, I argue that an ethical approach to overseeing innovative practice must encourage the early transition to rigorous clinical research without delaying or deferring the development of beneficial innovations or violating the autonomy rights of clinicians and their patients. (shrink)

The paper reports results of the very first survey-based study on the prevalence, frequency and nature of ethical or other non-medical difficulties faced by Polish physicians in their everyday clinical practice. The study involved 521 physicians of various medical specialties, practicing mainly in inpatient healthcare. The study showed that the majority of Polish physicians encounter ethical and other non-medical difficulties in making clinical decisions. However, they confront such difficulties less frequently than their foreign peers. Moreover, Polish doctors indicate (...) different circumstances as a source of the experienced problems. The difficulties most often reported relate to (i) patients (or their proxies) requests for medically non-indicated interventions; (ii) problems with communication with patients (or their proxies) due to the patients’ negative attitude, unwillingness to cooperate, or aggression; and (iii) various difficulties with obtaining informed consent. Polish physicians report difficulties associated with disagreements among care givers or scarcity of resources less frequently than doctors from other countries. The study’s findings provide support for the thesis that a significant portion of Polish physicians still follow a traditional, paternalistic, and hierarchical model of healthcare practice. Instead of promoting patient’s empowerment, engagement, and rights, they often consider these ideas as a threat to physicians’ professional authority and autonomy. The study leads to the conclusion that due to insufficient training in medical ethics, communication skills, and medical law, many Polish physicians lack the knowledge and competence necessary to adequately respond to challenges posed by modern healthcare practice. (shrink)

Ontological realism aims at the development of high quality ontologies that faithfully represent what is general in reality and to use these ontologies to render heterogeneous data collections comparable. To achieve this second goal for clinical research datasets presupposes not merely (1) that the requisite ontologies already exist, but also (2) that the datasets in question are faithful to reality in the dual sense that (a) they denote only particulars and relationships between particulars that do in fact exist and (...) (b) they do this in terms of the types and type-level relationships described in these ontologies. While much attention has been devoted to (1), work on (2), which is the topic of this paper, is comparatively rare. Using Referent Tracking as basis, we describe a technical data wrangling strategy which consists in creating for each dataset a template that, when applied to each particular record in the dataset, leads to the generation of a collection of Referent Tracking Tuples (RTT) built out of unique identifiers for the entities described by means of the data items in the record. The proposed strategy is based on (i) the distinction between data and what data are about, and (ii) the explicit descriptions of portions of reality which RTTs provide and which range not only over the particulars described by data items in a dataset, but also over these data items themselves. This last feature allows us to describe particulars that are only implicitly referred to by the dataset; to provide information about correspondences between data items in a dataset; and to assert which data items are unjustifiably or redundantly present in or absent from the dataset. The approach has been tested on a dataset collected from patients seeking treatment for orofacial pain at two German universities and made available for the NIDCR-funded OPMQoL project. (shrink)

Introduction: Clinical practice guidelines (CPGs) are an important source of justification for clinical decisions in modern evidence-based practice. Yet, we have given little attention to how they argue their evidence. In particular, how do CPGs argue for treatment with long-term medications that are increasingly prescribed to older patients? Approach and rationale: I selected six disease-specific guidelines recommending treatment with five of the medication classes most commonly prescribed for seniors in Ontario, Canada. I considered the stated aims of these (...) CPGs and the techniques employed towards those aims. Finally, I reconstructed and logically analysed the arguments supporting recommendations for pharmacotherapy. Analysis: The primary function of CPGs is rhetorical, or persuasive, and their means of persuasion include both a display of their credibility and their argumentation. Arguments supporting pharmacotherapy recommendations for the target population follow a common inductive pattern: statistical generalization from randomized controlled trial (RCT) and meta-analysis evidence. Two of the CPGs also argue their treatment recommendations for older patients in this style, while three fail to justify pharmacotherapy specifically for the older population. Discussion: The arguments analysed lack the auxiliary assumptions that would warrant making a generalization about the clinical effectiveness of medications for the older population. Guidelines reason using simple induction, while ignoring important inferential gaps. Future guidelines should aspire to be well-reasoned rather than simply evidence-based; argue from a plurality of evidence; be wary of hasty inductions; appropriately limit the scope of their recommendations; and avoid making law-like, prescriptive generalizations. (shrink)

Many extant theories of placebo focus on their causal structure wherein placebo effects are those that originate from select features of the therapy (e.g., client expectations or “incidental” features like size and shape). Although such accounts can distinguish placebos from standard medical treatments, they cannot distinguish placebos from everyday occurrences, for example, when positive feedback improves our performance on a task. Providing a social-epistemological account of a treatment context can rule out such occurrences, and furthermore reveal a new way to (...) distinguish clinical placebos from standard medical treatments. (shrink)

The prospect of vaccinating children and young people (CYP) against COVID raises questions that apply more widely to vaccination in children. When can CYP consent, on their own, for vaccination? What should happen if children and their parents disagree about the desirability of a vaccine? When, if ever, should vaccination proceed despite a child’s dissent or apparent refusal? A range of ethical dilemmas may arise. (Box 1) In this article, we will address general ethical issues relating to consent for vaccination, (...) highlighting their relevance to COVID. We will not address the wider ethical questions of whether or when children should be vaccinated against COVID. (shrink)

I argue that generic generalizations expressed in language (i.e., “generics”) are apt for good clinical reasoning. I begin by introducing what generics are in language and describe two problems in the use and interpretation of generics: Generics can license inaccurate judgements about the frequency of events or properties within a group (i.e., a problem with the “truth-aptness” of generics) and can facilitate problematic beliefs about social kinds (e.g., prejudice or essentializing). I provide an account of clinical reasoning and (...) describe some features of what I call “good” clinical reasoning. I offer examples of generics in clinical contexts and examine how the two problems with generics (i.e., of truth-aptness and social generics) can be harmful to patients and impair clinical reasoning. However, I ultimately argue that generics are important for good clinical reasoning because they track “conspicuous” features of disease processes (e.g., severe possible outcomes). Further, I argue that prejudicial generics are often irrational to believe, and social generics that are rational to believe need not lead to problematic implicatures about social kinds and can, in principle, instead facilitate meaningfully articulating societal injustices. I then argue that statistical statements, which are tempting alternatives to generics in clinical reasoning, are no better than generics for good clinical reasoning, even with respect to the two problems identified in the use of generics. (shrink)

Diabetic ketoacidosis is a serious, medical emergency that can be fatal but treatable, we aimed to evaluate the clinical profile of patients admitted with diabetic ketoacidosis. This case series study enrolled 213 non-pregnant adult and adolescent patients admitted with diabetic ketoacidosis at Tripoli Diabetes Hospital from January to September 2023. Demographic data, clinical characteristics, laboratory findings, precipitating factors, and patient outcomes were extracted from medical records and analyzed. Type 1 diabetes mellitus was present in 187 (87.8%) of patients, (...) the age range 11-84 years, (30.26±13.28), with 130 patients ≤30 years old (61.0%), females accounting for 110 of the patients (51.6%), 109 had a diabetes duration of less than 10 years (51.2%). The most common precipitating factor was insulin omission 92 (43.2%) in patients with known diabetes mellitus, whereas, diabetic ketoacidosis as the first presentation of diabetes mellitus in 24 patients (11.7%), systolic blood pressure ranged 50-160 mmHg (112.82±16.19), diastolic blood pressure varied 30-100 mmHg (70.24±11.32). Plasma glucose at presentation ranged 183-1494 mg/dl (462.92±169.85), with Eu-glycemic diabetic ketoacidosis 100-249 mg/dl were in nine patients (4.2%), whereas most of cases (135 patients, 63.4%) present with plasma glucose 250-500 mg/dl, while hyperosmolar status (≥701 mg/dl) were present in 13 patients (6.1%). Venous pH varied from 6.7-7.42 (7.13±0.14), 132 (62.0%) patients presented with pH <7.24, while severe acidosis was pH < 7 in 32 of patients (14.6%), serum bicarbonate with 10.93±4.95, severe (<5 mmol) in 91 patients (42.7%) and moderate (5-10 mmol) were in 79 patients (37.08%). The mean length of hospital stay was 3.33 days, with an average of 2.11 days spent in the high-dependent unit. Serum potassium varied from 2.4-6.7 meq/L with 3.66± 0.63, most common complications of diabetic ketoacidosis treatment were hypokalemia observed in 82 (35.7%) of cases, and hypoglycemia was detected in 41 patients (19.2%). 170 patients were discharged in good condition (79.8%), and 17.8% of patients were transferred to another hospital to receive further management for co-morbid diseases with diabetes after controlling their hyperglycemic crises. The majority of patients presented with the critical status of diabetic ketoacidosis. The findings emphasize the importance of patient education about prevention measures prompt presentation to the hospital, and clinicians' awareness for early and aggressive treatment of hyperglycemic crises. (shrink)

Regarding the appropriateness of deception in clinical practice, two (apparently conflicting) claims are often emphasised. First, that ‘clinicians should not deceive their patients.’ Second, that deception is sometimes ‘in a patient’s best interest.’ Recently, Hardman has worked towards resolving this conflict by exploring ways in which deceptive and non-deceptive practices extend beyond consideration of patients’ beliefs. In short, some practices only seem deceptive because of the (common) assumption that non-deceptive care is solely aimed at fostering true beliefs. Non-deceptive care, (...) however, relates to patients’ non-doxastic attitudes in important ways as well. As such, Hardman suggests that by focusing on belief alone, we sometimes misidentify non-deceptive care as ‘deceptive’. Further, once we consider patients’ beliefs and non-doxastic attitudes, identifying cases of deception becomes more difficult than it may seem. In this essay, I argue that Hardman’s reasoning contains at least three serious flaws. First, his account of deception is underdeveloped, as it does not state whether deception must be intentional. The problem is that if intention is not required, absurd results follow. Alternatively, if intention is required, then identifying cases of deception will be much easier (in principle) than Hardman suggests. Second, Hardman mischaracterises the ‘inverse’ of deceptive care. Doing so leads to the mistaken conclusion that common conceptions of non-deceptive care are unjustifiably narrow. Third, Hardman fails to adequately separate questions about deception from questions about normativity. By addressing these issues, however, we can preserve some of Hardman’s most important insights, although in a much simpler, more principled way. (shrink)

The desideratum of semantic interoperability has been intensively discussed in medical informatics circles in recent years. Originally, experts assumed that this issue could be sufficiently addressed by insisting simply on the application of shared clinical terminologies or clinical information models. However, the use of the term ‘ontology’ has been steadily increasing more recently. We discuss criteria for distinguishing clinical ontologies from clinical terminologies and information models. Then, we briefly present the role clinical ontologies play in (...) two multicentric research projects. Finally, we discuss the interactions between these different kinds of knowledge representation artifacts and the stakeholders involved in developing interoperational real-world clinical applications. We provide ontology engineering examples from two EU-funded projects. (shrink)

Albert Jonsen and Stephen Toulmin have argued that the best way to resolve complex “moral” issues in clinical settings is to focus on the details of specific cases. This approach to medical decision-making, labeled ‘casuistry’, has met with much criticism in recent years. In response to this criticism, Carson Strong has attempted to salvage much of Jonsen’s and Toulmin’s version of casuistry. He concludes that much of their analysis, including Jonsen’s further elaboration about the casuistic methodology, is on the (...) mark. In this essay, the details of Jonsen’s and Toulmin’s version of casuistry and the major criticisms against their approach to clinical decision-making are explicated. Furthermore, it is argued that Strong’s salvage efforts fail to deflect these criticisms. The upshot of this analysis, which includes a few additional criticisms, is that Jonsen’s and Toulmin’s version of casuistry is not an appropriate framework from which to resolve complex “moral” issues in clinical settings. (shrink)

When discussing the safety of research subjects, including their exploitation and vulnerability as well as failures in clinical research, recent commentators have focused mostly on countries with low or middle-income economies. High-income countries are seen as relatively safe and well-regulated. This article presents irregularities in clinical trials in an EU member state, Poland, which were revealed by the Supreme Audit Office of Poland (the NIK). Despite adopting many European Union regulations, including European Commission directives concerning Good Clinical (...) Practice, these irregularities occurred. Causes as well as potential solutions to make clinical trials more ethical and safer are discussed. (shrink)

The practice of social studies continues to be a complicated scientific endeavor. From an epistemological point of view, the social sciences, unlike the natural sciences, do not conform to the predominant definition of science. The existing differences among expositions of “science,” “inquiry,” and “studies” lie with the contested role of the intellectual who is embarked on understanding the social realm. The “maturity” of the social sciences is usually discussed in the context of objectivity and rationality. But continuing epistemological debates would (...) be insufficient without reference to the scholar as a human studying humans. The philosophy of science has focused mainly on the procedures of knowledge accumulation, neglecting social context and its implications for inquiry. To address this neglect, this essay sets out first to retrace doubts about the role of the scholar that emerged with the institutionalization of the social sciences at the outset of the twentieth century and then to rethink these issues in terms of recent scientific developments. What surfaces is a new, participatory role for scholars that demands responsible contextualization and a broader conception of causal stories. (shrink)

The theory of granular partitions (TGP) is a new approach to the understanding of ontologies and other classificatory systems. The paper explores the use of this new theory in the treatment of task-based clinical guidelines as a means for better understanding the relations between different clinical tasks, both within the framework of a single guideline and between related guidelines. We used as our starting point a DAML+OIL-based ontology for the WHO guideline for hypertension management, comparing this with related (...) guidelines and attempting to show that TGP provides a flexible and highly expressive basis for the manipulation of ontologies of a sort which might be useful in providing more adequate Computer Interpretable Guideline Models (CIGMs) in the future. (shrink)

CLE aims and clients’ needs conflict where students’ interests are put beyond clients’ needs. Students have interests in gaining employment, impressing instructors and supervisors, and experiencing the active application of law. Where the clients’ service-needs are subordinated to students’ interests, the relationship between the two—the ‘tension’—is tilted in a manner in which the clients are disserved through the fulfilment of students’ interests. This may be exacerbated by faulty institutional cultures where clinical faculty are treated differently, or as less accomplished (...) or ‘worthwhile’ than their ‘traditional’ counterparts. This also emphasizes that it is the clinical law faculty who may exacerbate or assuage the tension, as it is for clinical faculty to assure that clients’ needs are met on ethical grounds,20 and to equate the practice of law with excellence before students. (shrink)

Background: The internationalization of clinical studies requires a shared understanding of the fundamental ethical values guiding clinical studies. It is important that these values are not only embraced at the legal level but also adopted by clinicians themselves during clinical studies. Objective: Our goal is to provide an insight on how clinicians in Germany and Poland perceive and identify the different ethical issues regarding informed consent in clinical studies. Methods: To gain an understanding of how clinicians (...) view clinical studies in the countries they work in, we carried out semi-structured problem-centered interviews per telephone in Poland (n = 6) and Germany (n = 6). Our interviewees concentrated on three main topics: an appraisal of the normative framework, challenges in the information process and the protection of all participants in clinical studies. Results: Clinicians generally supported the normative framework, even though they considered it quite complex. In the two study countries, a widely noted dilemma in the information process was whether to overburden participants with extensive information or risking leaving out important facts. Clinicians were ready to exclude larger population groups from participating in clinical studies when the information process could not be carried out with standard procedures or when their inclusion was ethically sensitive. Conclusion: Clinicians need to gain a better understanding of the consequences of excluding larger population groups form participating in clinical studies. They should seek assistance in improving the information process for the inclusion of underrepresented groups in clinical studies. (shrink)

Machine learning algorithms may radically improve our ability to diagnose and treat disease. For moral, legal, and scientific reasons, it is essential that doctors and patients be able to understand and explain the predictions of these models. Scalable, customisable, and ethical solutions can be achieved by working together with relevant stakeholders, including patients, data scientists, and policy makers.

The UN Convention against Torture defines torture as “any act by which severe pain or suffering, whether physical or mental, is intentionally inflicted on a person” by someone acting in an official capacity for purposes such as obtaining a confession or punishing or intimidating that person.1 It is unethical for healthcare professionals to participate in torture, including any use of medical knowledge or skill to facilitate torture or allow it to continue, or to be present during torture.2-7 Yet medical participation (...) in torture has taken place throughout the world and was a prominent feature of the US interrogation practice in military and Central Intelligence Agency (CIA) detention facilities in the years after the attacks of 11 September 2001.8-11 Little attention has been paid, however, to how a regime of torture affects the ability of health professionals to meet their obligations regarding routine clinical care for detainees. -/- The 2016 release of previously classified portions of guideline from the CIA regarding medical practice in its secret detention facilities sheds light on that question. These show that the CIA instructed healthcare professions to subordinate their fundamental ethical obligations regarding professional standards of care to further the objectives of the torturers. (shrink)

The article presents the advantages and limitations of adaptive clinical trials for assessing the effectiveness of medical interventions and specifies the conditions that contributed to their development and implementation in clinical practice. I advance two arguments by discussing different cases of adaptive trials. The normative argument is that responsible adaptation should be taken seriously as a new way of doing clinical research insofar as a valid justification, sufficient understanding, and adequate operational conditions are provided. The second argument (...) is historical. The development of adaptive trials can be related to lessons learned from research in cases of urgency and to the decades-long efforts to end the productivity crisis of pharmaceutical research, which led to the emergence of translational, personalized, and, recently, precision medicine movements. (shrink)

The Belmont Report was written by a US Commission charged by the US Congress to advise on research supported by the US government. Its focus was understandably domestic. In the 40 years since its publication, clinical research has become increasingly international. Many clinical trials have sites in multiple countries, and many of the host countries are relatively impoverished. Such research raises some distinctive ethical issues. This paper outlines some of the key ethical challenges that have been raised by (...) clinical research conducted in low- and middle-income countries (LMICs) and sponsored by high-income country (HIC) institutions. It then considers whether the Belmont Report has the resources to address these problems and argues that it does not. The article closes by noting some parallels between this international research and domestic US research, which suggest that the US might benefit from the discussions abroad. (shrink)

Built-in decision thresholds for AI diagnostics are ethically problematic, as patients may differ in their attitudes about the risk of false-positive and false-negative results, which will require that clinicians assess patient values.

The following discourse is a brief yet appealing comparative analysis of two viewpoints on the same subject of Karma Yoga (detached 'witness–consciousness' through action) written separately by two stalwarts of Indian philosophy: Rabindranath Tagore (1915) and Swami Vivekananda (1896).

A commonly accepted claim by philosophers investigating the nature of evil is that the evil person is, in some way, the mirror image of the moral saint. In this paper I will defend a new version of this thesis. I will argue that both the moral saint and the morally evil person are characterized by a lack of conflict between moral and non-moral concerns. However, while the saint achieves this unity through a reconciliation of the two, the evil person does (...) so by eliminating moral concerns from her character. (shrink)

Phenomenology gives rise to certain ontological considerations that have far-reaching implications for standard conceptions of patient autonomy in medical ethics, and, as a result, the obligations of and to patients in clinical decision-making contexts. One such consideration is the phenomenological reduction in classical phenomenology, a core feature of which is the characterisation of our primary experiences as immediately and inherently meaningful. This paper builds on and extends the analyses of the phenomenological reduction in the works of Husserl, Heidegger, and (...) Merleau-Ponty in order to identify and explain its implications for our current understanding of the principle of respect for patient autonomy and the norms of clinical decision making. (shrink)

I will open the first part of this paper by trying to elucidate the frequentist foundations of RCTs. I will then present a number of methodological objections against the viability of these inferential principles in the conduct of actual clinical trials. In the following section, I will explore the main ethical issues in frequentist trials, namely those related to randomisation and the use of stopping rules. In the final section of the first part, I will analyse why RCTs were (...) accepted for regulatory purposes. I contend that their main virtue, from a regulatory viewpoint, is their impartiality, which is grounded in randomisation and fixed rules for the interpretation of the experiment. Thus the question will be whether Bayesian trials can match or exceed the achievements of frequentist RCTs in all these respects. In the second part of the paper, I will first present a quick glimpse of the introduction of Bayesianism in the field of medical experiments, followed by a summary presentation of the basic tenets of a Bayesian trial. The point here is to show that there is no such thing as “a” Bayesian trial. Bayesianism can ground many different approaches to medical experiments and we should assess their respective virtues separately. Thus I present two actual trials, planned with different goals in mind, and assess their respective epistemic, ethical and regulatory merits. In a tentative conclusion, I contend that, given the constraints imposed by our current regulatory framework, impartiality should preside over the design of clinical trials, even at the expense of many of their inferential and ethical virtues. (shrink)

The volume of clinical research is increasing exponentially—far beyond our ability to process and absorb the results. Given this situation, it may be beneficial to consider reducing the flow at its source. In what follows, I will motivate and critically evaluate the following proposal: researchers should conduct fewer clinical trials. More specifically, I c onsider whether researchers should be permitted to conduct only clinical research of very high quality and, in turn, whether research ethics committees should prohibit (...) all other, lower-quality research, even when it might appear to meet some minimal ethical standard. Following a close analysis of the social-value requirement of ethical clinical research, I argue that this proposal is defensible. The problem identified in this paper has two parts, quantity and quality, and some clarification is needed about the latter because “quality” is a highly contested term in the medical literature. When some scholars advocate for high-quality trials, they mean large-scale, simple, explanatory randomized controlled trials. Others, including myself, have defended a different characterization of high-quality research that tends more toward pragmatic trial design and the use of methods other than RCTs. Pragmatic trials aim to provide evidence that directly supports clinical decision-making in “usual” care settings. Unlike explanatory trials, which aim to abstract away from particular settings and patients, in the hopes of creating ideal conditions for the success of an intervention, pragmatic trials deliberately pursue knowledge of high applicability, through the use of representative subjects, clinically important questions, flexible treatment protocols, patient-oriented outcome measures, and so on. I see applicability as a marker of high-quality research. The context in which research is meant to be applied should be the context in which new interventions are evaluated. (shrink)

Our goal in this paper is to articulate a precise concept of at least a certain kind of disease-mongering, showing how pharmaceutical marketing can commercially exploit certain diseases when their best definition is given through the success of a treatment in a clinical trial. We distinguish two types of disease-mongering according to the way they exploit the definition of the trial population for marketing purposes. We argue that behind these two forms of disease-mongering there are two well-known problems in (...) the statistical methodology of clinical trials (the reference class problem and the distinction between statistical and clinical significance). Overcoming them is far from simple. (shrink)

Machine intelligence already helps medical staff with a number of tasks. Ethical decision-making, however, has not been handed over to computers. In this proof-of-concept study, we show how an algorithm based on Beauchamp and Childress’ prima-facie principles could be employed to advise on a range of moral dilemma situations that occur in medical institutions. We explain why we chose fuzzy cognitive maps to set up the advisory system and how we utilized machine learning to train it. We report on the (...) difficult task of operationalizing the principles of beneficence, non-maleficence and patient autonomy, and describe how we selected suitable input parameters that we extracted from a training dataset of clinical cases. The first performance results are promising, but an algorithmic approach to ethics also comes with several weaknesses and limitations. Should one really entrust the sensitive domain of clinical ethics to machine intelligence? (shrink)

For each of the many goals of an agent it is true that the agent wants its realization. Given further very plausible assumptions, one can show that there is no good reason for an agent not to want the realization of all of his goals. However, it seems also true that reaching all of one’s goals would be extremely boring; most human beings would consider such a life not worth living. In this respect, leading a life is like playing some (...) game: A game loses its point if one always easily wins. Human agents not only pursue goals but they also have the second-order desire to lead the life of a goal-pursuer. More precisely, they want to be goal-pursuers such that many but not all of their goals are being realized. I argue here that they have a good reason not to want the realization of all of their goals. Now, all this constitutes an antinomy: Apparently, there are very plausible arguments both for affirming as well as denying that an agent has good reasons not to want the realization of his goals. This antinomy is similar to the preface-paradox about beliefs which has a convincing solution (due to Frank Ramsey). I argue, however, that there is no such solution in the case of goals. This leaves us with the question what a solution could look like. (shrink)

This article addresses two areas of continuing controversy about consent in clinical research: the question of when consent to low risk research is necessary, and the question of when consent to research is valid. The article identifies a number of considerations relevant to determining whether consent is necessary, chief of which is whether the study would involve subjects in ways that would (otherwise) infringe their rights. When consent is necessary, there is a further question of under what conditions consent (...) is valid or successful in waiving a right. The most influential account of validity conditions is non-moralized, in the sense that the conditions make no essential reference to whether the researcher soliciting consent has obtained it in a way that wrongs the subject. The article examines the implications of this account, and compares it with recent accounts that moralize some of the validity conditions. -/- . (shrink)

How reliable are causal inferences in complex empirical scenarios? For example, a physician prescribes a drug to a patient, and then the patient undergoes various changes to their symptoms. They then increase their confidence that it is the drug that causes such changes. Are such inferences reliable guides to the causal relation in question, particularly when the physician can gain a large volume of such clinical experience by treating many patients? The evidence-based medicine movement says no, while some physicians (...) and philosophers support such appeals to first-person experience. We develop a formal model and simulate causal inference based on clinical experience. We conclude that in very particular clinical scenarios such inference can be reliable, while in many other routine clinical scenarios such inferences are not reliable. (shrink)

Janet Malek (91–102, 2019) argues that a “clinical ethics consultant’s religious worldview has no place in developing ethical recommendations or communicating about them with patients, surrogates, and clinicians.” She offers five types of arguments in support of this thesis: arguments from consensus, clarity, availability, consistency, and autonomy. This essay shows that there are serious problems for each of Malek’s arguments. None of them is sufficient to motivate her thesis. Thus, if it is true that the religious worldview of (...) class='Hi'>clinical ethics consultants should play no role whatsoever in their work as consultants, this claim will need to be defended on some other ground. (shrink)

Default positions, predetermined starting points that aid in complex decision-making, are common in clinical medicine. In this article, we identify and critically examine common default positions in clinical ethics practice. Whether default positions ought to be held is an important normative question, but here we are primarily interested in the descriptive, rather than normative, properties of default positions. We argue that default positions in clinical ethics function to protect and promote important values in medicine—respect for persons, utility, (...) and justice. Further, default positions in clinical ethics may also guard against harm. Where default positions exist, there are epistemic burdens to overturn them. The person wishing to reject the default position, rather than the person endorsing it, bears this burden. The person who bears the burden of meeting the epistemic requirements must provide evidence proportional to the degree of harm the default position protects against. Default positions that protect against significant harm impose significant epistemic requirements to overturn. This asymmetry not only makes medical decision-making more economical but also serves to promote and protect certain values. The identification and analysis of common and recognizable default positions can help to identify other default positions and the conditions under which their associated epistemic requirements are met. The article concludes with considerations of potential problems with the use of default positions in clinical ethics. (shrink)