Research question and aimClinical Ethics Committees (CECs) aim to support healthcare professionals (HPs) and healthcare organizations to deal with the ethical issues of clinical practice. In 2020,...

For decades a debate has played out in the literature about who bioethicists are, what they do, whether they can be considered professionals qua bioethicists, and, if so, what professional responsibilities they are called to uphold. Health care ethics consultants are bioethicists who work in health care settings. They have been seeking guidance documents that speak to their special relationships/duties toward those they serve. By approving a Code of Ethics and Professional Responsibilities for Health Care Ethics Consultants, the American Society (...) for Bioethics and Humanities (ASBH) has moved the professionalization debate forward in a significant way. This first code of ethics focuses on individuals who provide health care ethics consultation (HCEC) in clinical settings. The evolution of the code's development, implications for the field of HCEC and bioethics, and considerations for future directions are presented here. (shrink)

American Academy of Pediatrics (AAP) and American College of Medical Genetics (ACMG) recently provided two recommendations about predictive genetic testing of children. The Clinical Sequencing Exploratory Research Consortium's Pediatrics Working Group compared these recommendations, focusing on operational and ethical issues specific to decision making for children. Content analysis of the statements addresses two issues: (1) how these recommendations characterize and analyze locus of decision making, as well as the risks and benefits of testing, and (2) whether the guidelines conflict (...) or come to different but compatible conclusions because they consider different testing scenarios. These statements differ in ethically significant ways. AAP/ACMG analyzes risks and benefits using best interests of the child and recommends that, absent ameliorative interventions available during childhood, clinicians should generally decline to order testing. Parents authorize focused tests. ACMG analyzes risks and benefits using the interests of the child and other family members and recommends that sequencing results be examined for additional variants that can lead to ameliorative interventions, regardless of age, which laboratories should report to clinicians who should contextualize the results. Parents must accept additional analysis. The ethical arguments in these statements appear to be in tension with each other. (shrink)

This book is about the ethical issues that clinicians encounter as they care for patients and is written to assist those who serve on hospital ethics committees as they deliberate about appropriate action in difficult ethical cases.

In this paper I attempt to address what appears to be a novel theoretical and practical problem concerning physician-assisted suicide (PAS). This problem arises out of a newly created set of circumstances in which persons are hospitalized in jurisdictions where PAS, though now legally available to patients, remains morally contentious. When moral disagreements over PAS come to divide physicians, patients, and family members, it is quite likely they will today find their way to the hospital’s consulting ethicist, a member of (...) an emerging group of professionals charged with the responsibility (so we are told) of resolving moral conflict in the clinic. What can or should an ethics consultant do to fulfill this mandate in such circumstances? I argue that the now predominant conception of clinical ethics consultation is importantly deficient in that it provides no final guidance to ethicists on how they should respond in such cases. The ethicist may only recommend—or assist others to reach—solutions to moral disagreements falling within the limits of established norms. Since the normative landscape of PAS appears to be changing, whether it falls within these limits is unsettled. I conclude that the accepted goals of ethics consultation require a revised and expanded conception of the ethicist's role in cases involving PAS. I close by outlining what that revised understanding would look like and the further questions it raises. (shrink)

As the_number of clinical trials continues to grow, there is an increasing need for education and training in the field. The clinical research climate is less forgiving of errors and oversights and therefore requires more knowledge of regulations and requirements. This brand new edition details new laws and regulations in protecting children participating in clinical trials and how a new focus on privacy of individual health information in the United States has changed how medical records are handled. (...) Includes a manual for investigators, research nurses and study coordinators with minimal experience or who are new to clinical research An easy-to-read and open text design using ‘sidebars’ of examples and information boxes related to the main text Includes a list of Frequently Asked Questions and Glossary Duke Clinical Research Institute is the world’s largest academic clinical research organisation and is well known and respected within the clinical research community. (shrink)

This book is about the ethical issues that clinicians encounter as they care for patients and is written to assist those who serve on hospital ethics committees as they deliberate about appropriate action in difficult ethical cases.

This systematic review identifies and critically evaluates instruments that have been developed to measure clinical trial informed consent comprehension in non-cognitively-impaired adults.Literature searches were carried out on Medline (Ovid), PsycInfo, CINHAL, ERIC, ScienceDirect, and Cochrane Library for English language articles published between January 1980 and September 2008. Instruments were excluded if they focused on consent onto paediatric trials, the construct under study was primarily capacity or competency, or the instrument was developed specifically for psychiatric or cognitively-impaired populations. Instruments selected (...) for review were evaluated against the following criteria: (1) method of item generation; (2) type and format of test items; (3) administration and interpretation of test results; and (4) psychometric properties.Three instruments met our defined inclusion criteria: the Deaconess Informed Consent Comprehension Test (DICCT), the Quality of Informed Consent (QuIC) questionnaire and the Brief Informed Consent Protocol (BICEP). Each instrument varied in terms of content measured. Significantly, these are the first standardized instruments developed to assess comprehension in non-cognitively-impaired adults. Yet, each instrument had its own set of limitations such as the lack of generalizability and the absence of details pertaining to how test results should be used to guide clinical decision-making.Standardized clinical trial informed consent comprehension assessments have been developed to identify gaps in research participants' understanding and ensure that respect for patient autonomy is satisfied. (shrink)

​The motivation for this volume is simple. For a variety of reasons, clinical psychologists have long shown considerable interest in the philosophy of science. When logical positivism gained currency in the 1930s, psychologists were among the most avid readers of what these philosophers had to say about science. Part of the critique of Skinner’s radical behaviorism and thus behavior therapy was that it relied on, and thus was logically dependent on, the truth of logical positivism—a claim decisively refuted both (...) historically and logically by L.D. Smith (1986) in his important Behaviorism and Logical Positivism: A Reassessment of the Alliance. ​. (shrink)

This book discusses 'how' to respectfully and responsibly include pregnant women in clinical research. In sharp contrast, the existing literature predominantly focuses on the reasons 'why' the inclusion of pregnant women in clinical research is necessary - viz., to develop effective treatments for women during pregnancy, to promote fetal safety, to reduce harm to women and fetuses from suboptimal care, and to allow access to the benefits of research participation. This book supports the shift to a new default (...) position, whereby pregnant women are included in clinical research unless researchers argue convincingly for their exclusion. This shift raises many as yet unexplored ethical and policy questions about existing barriers to the equitable inclusion of pregnant women in research. This book is original in three key ways. First, it presents an unparalleled depth of analysis of the ethics of research with pregnant women, bringing together many of the key authors in this field as well as experts in research ethics and in vulnerability who have not previously applied their work to pregnant women. Second, it includes innovative theoretical work in ethics and disease specific case studies that highlight the current complexity and future challenges of research involving pregnant women. Third, the book brings together authors who argue both for and against including more pregnant women in formal clinical trials. (shrink)

There is the world of ideas and the world of practice; the French are often for sup pressing the one and the English the other; but neither is to be suppressed. -Matthew Arnold The Function of Criticism at the Present Time From its inception, bioethics has confronted the need to reconcile theory and practice. At first the confrontation was purely intellectual, as writers on ethical theory (within phi losophy, theology, or other humanistic disciplines) turned their attention to topics from the (...) world of medical practice. Recently the confrontation has grown more intense. The ap pointment of clinical ethicists in hospitals and other health care settings is an accelerating trend in North America. Concomitantly, those institutions involved in training peo ple in clinical ethics have added organized exposure to the world of practice, in the form of placement requirements, to the normal academic course load. In common with other dis ciplines, bioethics has begun to see clinical training as a con dition of didactic theory and apprenticeship. (shrink)

Critical Thinking in Clinical Research explains the fundamentals of clinical research in a case-based approach. The core concept is to combine a clear and concise transfer of information and knowledge with an engagement of the reader to develop a mastery of learning and critical thinking skills. The book addresses the main concepts of clinical research, basics of biostatistics, advanced topics in applied biostatistics, and practical aspects of clinical research, with emphasis on clinical relevance across all (...) medical specialties. (shrink)

The different ways in which the three medieval societies of Byzantium, Latin Christendom, and Islam institutionalized the charitable impulse present in their respective faiths reflected the fundamentally different religious values which motivated these civilizations as well as their different levels of material and intellectual development. All three societies exalted the relief of human suffering, especially the care of the sick, as a religiously sanctioned gesture; and all three invented or adopted institutional means for attaining this pious objective. The various medieval (...) counterparts of the modern “hospital”—the Byzantine nosocomeion or xenodocheion, the European hospitale, and the Islamic maristan—differed significantly, however, with respect to their organization and operation, the clientele which they served, and the ultimate intent of their charitable efforts. Accordingly, a comparison of these social welfare institutions reveals the contrasting ways in which the two Christendoms and Islam defined and applied the ideals of “piety” and “charity” during the middle ages. (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)

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)

As a consequence of the COVID-19 pandemic, the number of decentralized clinical trials, trials conducted in whole or in part at locations other than traditional clinical trial sites, significantly increased. While these trials have the potential advantage of access, participant centricity, convenience, lower costs, and efficiency, they also raise a number of important ethical and practical concerns. Here we focus on a number of those concerns, including participant safety, privacy and confidentiality, remote consent, digital access and proficiency, and (...) trial oversight. Awareness of these ethical complexities will help foster the development of processes and cooperative solutions to promote safe, ethical trials going forward, optimized to decrease burden and increase access for all participants. (shrink)

Can machine intelligence do clinical ethics? And if so, would applying it to actual medical cases be desirable? In a recent target article (Meier et al. 2022), we described the piloting of our advisory algorithm METHAD. Here, we reply to commentaries published in response to our project. The commentaries fall into two broad categories: concrete criticism that concerns the development of METHAD; and the more general question as to whether one should employ decision-support systems of this kind—the debate we (...) set out to ignite with our target article. (shrink)

The outsourcing of clinical trials to Latin America by the transnational innovative pharmaceutical industry began about twenty years ago. Using archival information and field work in Argentina, Brazil, Costa Rica, Mexico and Peru, the authors discuss the regulatory contexts and the ethical dimensions of human experimentation in the region. More than 80% of all clinical trials in the region take place in these countries, and the European Medicines Agency has defined them as priority countries in Latin America. The (...) authors raise questions about the quality of data obtained from the trials and the violation of human rights during their implementation. Their findings are presented in this volume, the first in-depth analysis of clinical trials in the region.. (shrink)

Discovering Spinoza's early modern psychology some 35 years into his own clinical practice, Ian Miller now gives shape to this connection through a close reading of Spinoza's key philosophical ideas. With a rigorous and expansive analysis of Spinoza's Ethics in particular, Miller explores how Spinozan thought simultaneously empowered the original conceptual direction of psychoanalytic thinking, and anticipated the field's contemporary theoretical dimensions. Miller offers a detailed overview of the philosopher's psychoanalytic reception from the early work of German-language psychoanalytic thinkers, (...) such as Freud and Andreas Lou-Salome, forward into its Anglophone reception, influencing both mid-century humanistic American psychoanalysis as well as anticipating thinkers such as Bion and Winnicott. Covering key concepts in psychoanalytic theory and clinical practice, this book demonstrates how knowledge of Spinoza's philosophical work can help to both illuminate and improve modern psychoanalytic therapies. (shrink)

This book is derived from the author's Concise guide to ethics in mental health care, published in 2004. It has been revised, updated, and rewritten with new chapters, topics and data.

This study describes which clinical ethics approaches are available to support healthcare personnel in clinical practice in terms of their construction, functions and goals. Healthcare personnel frequently face ethically difficult situations in the course of their work and these issues cover a wide range of areas from prenatal care to end-of-life care. Although various forms of clinical ethics support have been developed, to our knowledge there is a lack of review studies describing which ethics support approaches are (...) available, how they are constructed and their goals in supporting healthcare personnel in clinical practice. This study engages in an integrative literature review. We searched for peer-reviewed academic articles written in English between 2000 and 2016 using specific Mesh terms and manual keywords in CINAHL, MEDLINE and Psych INFO databases. In total, 54 articles worldwide described clinical ethics support approaches that include clinical ethics consultation, clinical ethics committees, moral case deliberation, ethics rounds, ethics discussion groups, and ethics reflection groups. Clinical ethics consultation and clinical ethics committees have various roles and functions in different countries. They can provide healthcare personnel with advice and recommendations regarding the best course of action. Moral case deliberation, ethics rounds, ethics discussion groups and ethics reflection groups support the idea that group reflection increases insight into ethical issues. Clinical ethics support in the form of a “bottom-up” perspective might give healthcare personnel opportunities to think and reflect more than a “top-down” perspective. A “bottom-up” approach leaves the healthcare personnel with the moral responsibility for their choice of action in clinical practice, while a “top-down” approach risks removing such moral responsibility. (shrink)

Background The enhancement of nursing care quality is closely related to the clinical competence of nurses, making it a crucial component within health systems. Objective The present study investigated the relationship between nurses’ clinical competence, moral identity, and moral injury during the COVID-19 outbreak. Research design This cross-sectional study was carried out among frontline nurses, using the Moral Identity Questionnaire (MIQ), the Moral Injury Symptom Scale-Healthcare Professionals version (MISS-HP), and the Competency Inventory for Registered Nurse (CIRN) as data (...) collection tools. Participants and research context: The research population for this study consisted of all frontline nurses ( n = 251) employed in a hospital in southern Iran. Sampling was conducted between May 1, 2021 and September 30, 2021, during the COVID-19 outbreak. Ethical considerations The present study received approval from the research ethics committee of Rafsanjan University of Medical Sciences, with project No. 99267 and code of ethics ID No. IR. RUMS.REC.1399.262, dated 15.02.2021. Results According to the study findings, 42.2% of the nurses demonstrated high clinical competence, while 51.4% exhibited moderate clinical competence. The results indicated a positive correlation between moral identity and clinical competence but a negative correlation between moral injury and clinical competence. Furthermore, the variables of moral identity and moral injury were found to predict 10% of the variance in clinical competence. Conclusion According to the results, moral identity and moral injury had an impact on the clinical competence of nurses. Therefore, implementing a program aimed at enhancing moral identity and providing training strategies to address moral injury during crises like the COVID-19 pandemic can lead to improvements in nurses’ clinical competence and the overall quality of care they provide. (shrink)

Moral pluralism poses a foundational problem for secular clinical ethics: How can ethical dilemmas be resolved in a context where there is disagreement not only on particular cases, but further, on...

Decision-making depends on bringing evidence together with values: decision theory for example employs probabilities and utilities; health economic decisions employ measures such as quality of life. The hypothesis guiding this chapter is that bringing evidence together with values in clinical decision-making requires an exercise of phronesis. Our aim however is not to justify our guiding hypothesis. It is rather to outline an account of phronesis that is in principle fit for the purposes of clinical decision-making if our guiding (...) hypothesis is correct. The chapter has three sections. Section 1 describes the growing gap between evidence and values in clinical decision-making: the missing link, we suggest, required to bridge this gap, is an appropriate account of phronesis. Section 2 provides an initial characterisation of the required account of phronesis via Michael Polanyi’s twin stipulation on the nature of tacit knowledge. Section 3 then fills out the required account using John McDowell’s characterisation of phronesis as a situation specific but at the same time conceptually structured form of practical discernment. A McDowellian account of phronesis, we argue, in satisfying Polanyi’s twin stipulation, provides an in-principle bridge between evidence and values. We conclude with a note on some of the further requirements if the gap is to be bridged not only in principle but in practice too. (shrink)

This textbook offers an introduction to the field of bioethics, specifically from a practicing physician standpoint. It engages a wide range of recent scholarship and emerging research covering many crucial topics in clinical ethics. While there has been increasing attention to the role of bioethics in medicine, the gap between theory and practice still exists, and it continues to impede the dialogue between health care professionals from one side and bioethicists and philosophers of medicine from the other side. This (...) book builds bridges and open channels of connection between different parties in these conversations. It does so from a physician’s practical perspective, engaging recent scholarship and emerging research, to shed light on pivotal ethical dilemmas in contemporary clinical practice. (shrink)

This book offers a philosophically-based, yet clinically-oriented perspective on current medical reasoning aiming at 1) identifying important forms of uncertainty permeating current clinical reasoning and practice 2) promoting the application of an abductive methodology in the health context in order to deal with those clinical uncertainties 3) bridging the gap between biomedical knowledge, clinical practice, and research and values in both clinical and philosophical literature. With a clear philosophical emphasis, the book investigates themes lying at the (...) border between several disciplines, such as medicine, nursing, logic, epistemology, and philosophy of science; but also ethics, epidemiology, and statistics. At the same time, it critically discusses and compares several professional approaches to clinical practice such as the one of medical doctors, nurses and other clinical practitioners, showing the need for developing a unified framework of reasoning, which merges methods and resources from many different clinical but also non-clinical disciplines. In particular, this book shows how to leverage nursing knowledge and practice, which has been considerably neglected so far, to further shape the interdisciplinary nature of clinical reasoning. Furthermore, a thorough philosophical investigation on the values involved in health care is provided, based on both the clinical and philosophical literature. The book concludes by proposing an integrative approach to health and disease going beyond the so-called “classical biomedical model of care”. (shrink)

A systematic literature review on evaluation of clinical ethics support services in mental healthcare is presented and discussed. The focus was on (a) forms of clinical ethics support services, (b) evaluation of clinical ethics support services, (c) contexts and participants and (d) results. Five studies were included. The ethics support activities described were moral case deliberations and ethics rounds. Different qualitative and quantitative research methods were utilized. The results show that (a) participants felt that they gained an (...) increased insight into moral issues through systematic reflection; (b) there was improved cooperation among multidisciplinary team members; (c) it was uncertain whether clinical ethics support services led to better patient care; (d) the issue of patient and client participation is complex; and (e) the implementation process is challenging. Clinical ethics support services have mainly been studied through the experiences of the participating facilitators and healthcare professionals. Hence, there is limited knowledge of whether and how various types of clinical ethics support services influence the quality of care and how patients and relatives may evaluate clinical ethics support services. Based on the six excluded ‘grey zone articles’, in which there was an implicit focus on ethics reflection, other ways of working with ethical reflection in practice are discussed. Implementing and evaluating clinical ethics support services as approaches to clinical ethics support that are more integrated into the development of good practice are in focus. In order to meet some of the shortcomings of the field of clinical ethics support services, a research project that aims to strengthen ethics support in the mental health services, including patients’ and caregivers’ views on ethical challenges, is presented. (shrink)

Comprehensive in scope and research, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students alike.

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)

Background: International developments suggest that providing clinical ethics services to help clinicians negotiate ethical issues that arise in clinical practice is beneficial and reflects best practice in promoting high ethical standards and patient-centered care. The aim of this study was to explore the needs and experiences of clinical staff members to inform the development of future clinical ethics support. Methods: Health professionals at a large regional health service completed an online survey containing questions about the frequency (...) of ethical and legal issues encountered in clinical practice, the type of situations that gave rise to the ethical and/or legal uncertainty or concern, how clinicians currently address these issues, and what support would be welcome. Results: The survey was completed by 369 staff members, including 61% with more than 10 years in the profession and 51% in nursing/midwifery. Two-thirds (66%) indicated they often considered ethical implications of their clinical decisions, and half (49%) often considered the legal implications. More than half (58%) were often/occasionally concerned about the ethically right thing to do. Patient requests for borderline treatment (47%), staff disagreements about patient care (48%), and patients declining recommended treatment (54%) were the most frequent reasons given for ethical or legal uncertainty. Sixty-nine percent of respondents indicated that the way their department addressed ethical issues could be improved and 85% agreed that there is a need for more discussion on ethical issues. The majority (82%) of respondents had encountered ethically challenging clinical situations where additional support would have helped. Common approaches to issues were discussion with colleagues/supervisor (91.1%), discussion at handover/group forums (50.8%), and consultation with guidelines/protocols (60.9%). Conclusions: A majority of clinical staff members surveyed have encountered ethically/legally challenging cases daily for which they have often sought additional advice. This study indicates that many clinical staff members would welcome some form of additional clinical ethics support including advice and education. (shrink)

A collection of original comics engaging fundamental issues in medical ethics, including patient autonomy, informed consent, unconscious bias, mandated reporting of suspected abuse, confidentiality, medical mistakes, surrogate decision-making, and futility.

Despite its phenomenal success since its inception in the early nineteen-nineties, the evidence-based medicine movement has not succeeded in shaking off an epistemological critique derived from the experiential or tacit dimensions of clinical reasoning about particular individuals. This critique claims that the evidence-based medicine model does not take account of tacit knowing as developed by the philosopher Michael Polanyi. However, the epistemology of evidence-based medicine is premised on the elimination of the tacit dimension from clinical judgment. This is (...) demonstrated through analyzing the dichotomy between clinical and statistical intuition in evidence-based medicine’s epistemology of clinical reasoning. I argue that clinical epidemiology presents a more nuanced epistemological model for the application of statistical epidemiology to the clinical context. Polanyi’s theory of tacit knowing is compatible with the model of clinical reasoning associated with clinical epidemiology, but not evidence-based medicine. (shrink)

In an adaptive clinical trial , key trial characteristics may be altered during the course of the trial according to predefined rules in response to information that accumulates within the trial itself. In addition to having distinguishing scientific features, adaptive trials also may involve ethical considerations that differ from more traditional randomized trials. Better understanding of clinical trial experts’ views about the ethical aspects of adaptive designs could assist those planning ACTs. Our aim was to elucidate the opinions (...) of clinical trial experts regarding their beliefs about ethical aspects of ACTs. (shrink)

This paper explores the conduct of performance appraisals of nurses in a New Zealand hospital, and how fairness is perceived in such appraisals. In the health sector, performance appraisals of medical staff play a key role in implementing clinical governance, which, in turn, is critical to containing health care costs and ensuring quality patient care. Effective appraisals depend on employees perceiving their own appraisals to be fair both in terms of procedure and interaction with their respective appraiser. We examine (...) qualitative data from interviews and focus groups, involving 22 nurses in a single department, to determine whether perceived injustices impact on the effective implementation of the appraisal system. Our results suggest that particular issues had been causing some sense of injustice, and most of these were procedural. Potential solutions focus on greater formalisation of the performance appraisal process, and more training for appraisers and appraisees. (shrink)

The current process towards formalization within evaluation research, in particular the use of pre-set standards and the focus on predefined outcomes, implies a shift of ownership from the people who are actually involved in real clinical ethics support services in a specific context to external stakeholders who increasingly gain a say in what ‘good CESS’ should look like. The question is whether this does justice to the insights and needs of those who are directly involved in actual CESS practices, (...) be it as receivers or providers. We maintain that those actually involved in concrete CESS practices should also be involved in its evaluation, not only as respondents, but also in setting the agenda of the evaluation process and in articulating the criteria by which CESS is evaluated. Therefore, we propose a participatory approach to CESS evaluation. It focuses on the concrete contexts in which CESS takes place, reflective and dialogical learning processes, and how to be democratic and inclusive. In particular, this approach to CESS evaluation is akin to realist evaluation, dialogical evaluation, and responsive evaluation. An example of a participatory approach to evaluating CESS is presented and some critical issues concerning this approach are discussed. (shrink)

After a 50-page outline of the principles of clinical reasoning, over 60 actual cases are detailed that illustrate (and are keyed to) the principles, presenting case records, analysis, and references to literature. For medical students and interns, and their instructors. Annotation copyright Book Ne.

The attempt to critique the profession of clinical ethics consultation by establishing the impossibility of ethics expertise has been a red herring. Decisions made in clinical ethics cases are almost never based purely on moral judgments. Instead, they are all-things-considered judgments that involve determining how to balance other values as well. A standard of justified decision-making in this context would enable us to identify experts who could achieve these standards more often than others, and thus provide a basis (...) for expertise in clinical ethics consultation. This expertise relies in part on what Richard Zaner calls the “expert knowledge of ethical phenomena”. (shrink)

Book reviewed in this article: Clinical Ethics: A Practical Approach to Ethical Decisions in Clinical Medicine. By Albert R. Jonsen, Mark Siegler, and William J. Winslade.

Monothematic delusions involve a single theme, and often occur in the absence of a more general delusional belief system. They are cognitively atypical insofar as they are said to be held in the absence of evidence, are resistant to correction, and have bizarre contents. Empiricism about delusions has it that anomalous experience is causally implicated in their formation, whilst rationalism has it that delusions result from top down malfunctions from which anomalous experiences can follow. Within empiricism, two approaches to the (...) nature of the abnormality/abnormalities involved have been touted by philosophers and psychologists. One-factor approaches have it that monothematic delusions are a normal response to anomalous experiences whilst two-factor approaches seek to identify a clinically abnormal pattern of reasoning in addition to anomalous experience to explain the resultant delusion. In this paper we defend a one-factor approach. We begin by making clear what we mean by atypical, abnormal, and factor. We then identify the phenomenon of interest and overview one and two-factor empiricism about its formation. We critically evaluate the cases for various second factors, and find them all wanting. In light of this we turn to our one-factor account, identifying two ways in which ‘normal response’ may be understood, and how this bears on the discussion of one-factor theories up until this point. We then conjecture that what is at stake is a certain view about the epistemic responsibility of subjects with delusions, and the role of experience, in the context of familiar psychodynamic features. After responding to two objections, we conclude that the onus is on two-factor theorists to show that the one-factor account is inadequate. Until then, the one-factor account ought to be understood as the default position for explaining monothematic delusion formation and retention. We don’t rule out the possibility that, for particular subjects with delusions there may be a second factor at work causally implicated in their delusory beliefs but, until the case for the inadequacy of the single factor is made, the second factor is redundant and fails to pick out the minimum necessary for a monothematic delusion to be present. (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)

The first clinical ethics committees in Norway were established in 1996. This started as an initiative from hospital clinicians, the Norwegian Medical Association, and health authorities and politicians. Norwegian hospitals are, by and large, publicly funded through taxation, and all inpatient treatment is free of charge. Today, all the 23 hospital trusts have established at least one committee. Center for Medical Ethics , University of Oslo, receives an annual amount of US$335,000 from the Ministry of Health and Care Services (...) to coordinate the committees and to facilitate competency building for committee members. (shrink)

This article describes our efforts to screen and enrol clinical trial participants conscientiously in the COVID-19 pandemic setting. We present the standard screening and enrolment process prior to, and our process of adapting to, the pandemic. Our goal was to develop a way to screen and enrol people for clinical trials that was both equitable and effective. In addition, we outline the steps our research department took to ensure that ethical, clinical and logistical factors were considered when (...) matching a patient to a clinical trial. (shrink)

This paper focuses on the topic of evaluation of clinical ethics consultation. The concept of evaluation seems to contain an internal tension: On the one hand, evaluation is seen as distorting the conceptual and normative content of the case under scrutiny and, on the other, the evaluative act is the most important use of judgment and an inescapable part of everyday life. As such, we maintain that evaluation is essential.

Clinical ethics has developed significantly in Europe over the past 15 years and remains an evolving process. While sharing our experiences in different European settings, we were surprised to discover marked differences in our practice, especially regarding the position and role of patients. In this paper, we describe these differences, such as patient access to and participation or representation in ethics consults. We propose reasons to explain these differences, hypothesizing that they relate to the historic and sociocultural context of (...) implementation of clinical ethics consultation services (Cecs), as well as the initial aims for which each structure was established. Then, we analyse those differences with common ethical arguments arising in patient involvement. We conclude that there is no unique model of best practice for patient involvement in clinical ethics, as far as Cecs reflect on how to deal with the challenging ethical issues raised by patient role and position. (shrink)