Investigators and institutional review boards should integrate plans about the appropriate disclosure of individual genetic results when designing research studies. The ethical principles of beneficence, respect, reciprocity, and justice provide justification for routinely offering certain results to research participants. We propose a result-evaluation approach that assesses the expected information and the context of the study in order to decide whether results should be offered. According to this approach, the analytic validity and the clinical utility of a specific result (...) determine whether it should be offered routinely. Different results may therefore require different decisions even within the same study. We argue that the threshold of clinical utility for disclosing a result in a research study should be lower than the threshold used for clinical use of the same result. The personal meaning of a result provides additional criteria for evaluation. Finally, the context of the study allows for a more nuanced analysis by addressing the investigators' capabilities for appropriate disclosure, participants' alternative access to the result, and their relationship with the investigators. This analysis shows that the same result may require different decisions in different contexts. (shrink)

There is a burgeoning corner of the philosophical literature on germline gene editing (GGE) about whether GGE is “person-affecting” or “identify-affecting.” The distinction between actions that aff...

In the evaluation of genomic high-throughput technologies, the idea of “utility” plays an important role. The “clinical utility” of genomic data refers to the improvement of healthcare outcomes, its “personal utility” to benefits that go beyond healthcare purposes. Both concepts are contested. Moreover, there are only few empirical insights regarding their interpretation by those professionally involved or personally affected. Our paper presents results from qualitative research (20 semi-structured interviews) regarding professionals’ and personally affected people’s views on (...) the utility of genomic information. We find that the discussion of clinical utility is the domain of professionals who primarily consider aspects of test validity and clinical outcomes. By contrast, personal utility plays a prominent role in affected persons’ discussions. Four different aspects are addressed: (a) life and family planning, (b) relief and justification, (c) self-knowledge and self-determination, and (d) entertainment. These differences have important implications for informed consent and counseling in the context of genomic high-throughput technologies. (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)

Neural cell transplants have been introduced in clinical practice during the last decade with mixed results, encouraged by success with simple animal models. This commentary is a reminder that although the ideas and techniques of transplantation appear simple, the variables involved in host-transplant integration still require further study. The field may benefit from a concerted, multidisciplinary approach.

This paper describes one possible origin point for fraudulent behavior within the American pharmaceutical industry. We argue that during the late nineteenth century therapeutic reformers sought to promote both laboratory science and increasingly systematized forms of clinical experiment as a new basis for therapeutic knowledge. This process was intertwined with a transformation in the ethical framework in which medical science took place, one in which monopoly status was replaced by clinical utility as the primary arbiter of pharmaceutical (...) legitimacy. This new framework fundamentally altered the set of epistemic virtues—a phrase we draw from the philosophical field of virtue epistemology—considered necessary to conduct reliable scientific inquiry regarding drugs. In doing so, it also made possible new forms of fraud in which newly emergent epistemic virtues were violated. To make this argument, we focus on the efforts of Francis E. Stewart and George S. Davis of Parke, Davis & Company. Therapeutic reformers within the pharmaceutical industry, such as Stewart and Davis, were an important part of the broader normative and epistemic transformation we describe in that they sought to promote laboratory science and systematized clinical trials toward the twin goals of improving pharmaceutical science and promoting their own commercial interests. Yet, as we suggest, Parke, Davis & Company also serves as an example of a company that violated the very norms that Stewart and Davis helped introduce. We thus seek to describe one possible origin point for the widespread fraudulent practices that now characterize the pharmaceutical industry. We also seek to describe an origin point for why we conceptualize such practices as fraudulent in the first place. (shrink)

A clinical ethics fit for the Anthropocene—our current geological era in which human activity is the primary determinant of environmental change—needs to incorporate environmental ethics to be fit for clinical practice. Conservationist Aldo Leopold’s essay ‘The Land Ethic’ is probably the most widely-cited source in environmental philosophy; but Leopold’s work, and environmental ethics generally, has made little impression on clinical ethics. The Land Ethic holds that “A thing is right when it tends to preserve the integrity, stability, (...) and beauty of the biotic community. It is wrong when it tends otherwise.” I argue that a Land Ethic helps to re-frame problems in clinical ethics that more common philosophical approaches struggle to handle, and that it can be incorporated into clinical ethics without succumbing to “environmental fascism”. I motivate viewing problems in clinical ethics from the perspective of the ‘integrity of the biotic community’, then illustrate how this perspective can offer guidance where more commonly-invoked theories—such as consequentialism and Kantian-inspired approaches—struggle, using antimicrobial resistance in nosocomial infection as a case study. The Land Ethic equips us to understand human values as arising within and inseparable from a social-ecological context, and by treating communities as valuable in themselves rather than just through the aggregate welfare of their individual participants, we can avoid problems with the ‘repugnant conclusion’ and utility monster that plague utilitarian accounts. (shrink)

In the United States, the field of bioethics has expanded over the last two decades. Several institutions offer graduate-level training at both the masters and doctoral level. However, a lack of published literature on the outcomes of doctoral training in bioethics from the perspective of graduates exists. Researchers conducted an online survey of doctoral students who had finished all doctoral requirements but their dissertation, as well as doctoral graduates, of four US-based institutions to ascertain their perspectives on a number of (...) items regarding their doctoral training and their perception of how that training prepared them for their current role in the workforce. Responses from 34 participants were assessed. Respondents had positive overall views on the utility of a bioethics doctorate and the educational training they received in their respective programs. A number of areas for improvement were identified, including better structured clinical ethics training, greater opportunities for research and publishing, and having the ability to teach during their doctoral program, as well as formal pedagogy training. Greater exposure to clinical ethics consultation during the doctoral program was associated with feeling fully prepared as a clinical ethics consultant. This is the first study to assess the perspectives of bioethics doctoral graduates and ABD students regarding the utility of a bioethics doctorate. Per the perspectives of graduates and ABD students, bioethics doctorates are important and effective to train professional bioethicists. We recommend that a few key changes to these programs’ curricula can further bolster their effectiveness. (shrink)

Many healthy volunteers choose to take part in Alzheimer’s disease prevention studies because they want to know whether they will develop dementia—and what they can do to reduce their risk—and are therefore interested in learning the results of AD biomarker tests. Proponents of AD biomarker disclosure often refer to the personal utility of AD biomarkers, claiming that research participants will be able to use AD biomarker information for personal purposes, such as planning ahead or making important life decisions. In (...) this paper, the claim that AD biomarkers have personal utility for asymptomatic individuals is critically assessed. It demonstrates that in the absence of clinical validity, AD biomarkers cannot have personal utility and do not serve research participants’ autonomy. Over the next few years, many research groups will be confronted with participants’ preferences to learn the results of AD biomarker tests. When researchers choose to make results available upon explicit request, they should ensure adequate information provision and education, notably on the uncertain clinical significance of AD biomarker information. Routine disclosure of AD biomarkers to cognitively unimpaired individuals in research settings cannot be justified with an appeal to the personal utility of AD biomarker information. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Clinic as Testing Ground for Moral Theory: A European ViewHans-Martin Sass (bio)A Philosopher’s View of Theory in the Clinical SettingThe clinic is a testing ground for theories. I am not clinician; I am a philosopher who has been in the clinic only as a patient or as an ethicist who never has had the final word nor was ever intended to have the final word. I have (...) learned that in the clinical setting general norms and conceptualizations in the Kantian sense must be tailored to real-life situations. From the philosophical schools of analytical reasoning, I learned the skills needed to analyze words and meanings and to dissect problems and so-called “solutions.” But even more impressive are the methodological skills of differential diagnosis, looking at medical problems from different angles and using different methods and instruments. The detail- and patient-oriented work of the clinician provides an excellent model of methodological clarity and professional devotion for a philosopher who assists those working for the “good of the patient.” That model has led to the development of what I call a theory and methodology of differential ethics. [End Page 351]Differential ethics is normative ethics, as it does not give up norms in favor of situational utility. Differential ethics does not venture out empty-handed in order to explore and find principles pre-existing in a given situation; rather it brings basic values and principles along with it and tries to discover the shape they must take and the priority they must be given in the situation at hand. Differential ethics differentiates between general norms and mid-level principles, virtues, and visions that must be introduced and protected effectively and specifically according to different scenarios (Sass 1993). From this European point of view, I shall briefly explain my position and comment on (1) the controversy between principlism and virtue theory, (2) differentiating and balancing, and (3) the importance of trust, both as a principle and as a virtue in the clinical setting.Principlism Versus Virtue Theory: A Mistaken ControversyFrom a European perspective, I find that the debate between the schools of virtue-theory and principlism in the United States is a mistaken controversy. The real conflict between the schools of thought is not methodology, but content. Tom Beauchamp (1995) gives examples of how one language or method can be translated into the other, and Edmund Pellegrino and David Thomasma (1988, p. 206) have formulated a rule for the virtuous physician that, in the language of principlism, reads “respect for autonomy,” but in the language of virtue theory reads “To assist my patients to make choices that coincide with their own values or beliefs, without coercion, deception, or duplicity.”In different situations, however, some systems of reference are more authoritative and effective than others. Appealing to professional virtues would be the most efficacious way to address an audience coherent in attitudes and concerned about personal character. Reaffirmation of personal and professional obligations in secular fraternities or religious communities works best when it includes an appeal to virtues in the language of the humanist tradition, moral theology, or professional ethics.But there are other situations in which authoritative attitudes and expectations are absent and society in general is searching for common, often dormant, principles that will hold it together whatever specific disagreements arise. Such a situation was present in 1978 when the Belmont Report (National Commission 1978) presented principles—respect for autonomy, nonmaleficence, beneficence, justice—and not virtues to guide moral and political reflections on and reactions to the ethical, legal, and social implications of modern biomedicine in a multi-faceted and multi-cultural society.The formal difference between the systems of principlism, virtue theory, and value theory becomes even less important when clinical-ethical questionnaires are used to understand specific scenarios or cases and to assess different options for proceeding. Thus, my first thesis is: Case discussion, scenario assessment, [End Page 352] and open questionnaires, rather than definite guidelines, bridge the difference between virtue theory and principlism, since such processes can employ any one language or a combination of all three.Differentiating and BalancingMy second thesis is: Whatever system of reference is used... (shrink)

This paper aims to show that to reduce the level of exploitation present in (some) international clinical trials, research sponsors must aim to provide both an ex-ante expected gain in utility and a fair ex-post distribution of benefits for research subjects. I suggest the following principles of fair risk distribution in international research as the basis of a normative definition of fairness: (a) Persons should not be forced (by circumstance) to gamble in order to achieve or protect basic (...) goods; (b) In cases where one party is gambling with basic goods and the other party is not, the distribution of benefits and burdens must be arranged so that they are of greatest benefit to the worst off; (c) In relationships where one party is gambling for basic goods and the other party is not, the party gambling for basic goods must be assured of some guaranteed benefits in addition to the chance of gaining some potential benefits.These principles are applied to the case of HIV international research. I conclude that the research (as described) is mutually advantageous but still exploitative because the distribution of surplus benefits is unfair. It is unfair because research subjects are gambling with and for basic goods but they are not assured of a fair ex-post distribution of benefits. Principles (b) and (c) are not satisfied. Research participants are not accorded enough guaranteed benefits to outweigh the risks they undertake. (shrink)

ABSTRACTThis essay introduces the notion of a literary clinical practice for which it remains essential to continue to consider those texts that open up a place for a readership, or audience, or even a civilization to consider the endlessly generative failure of its literature to write mental health. Concerned with mental illness that is an effect of language on the subject, the body, and of the enigma of the truth as cause, psychoanalysis is the crucial interlocutor for any literary (...) clinical concern with the maladies of literature and society. In order to re-assess the utility of Shakespeare’s Hamlet to contemporary problems such as depression – perhaps the dominant symptom of our time – this essay attempts a reconsideration of Jacques Lacan’s famous seminar on Hamlet from the perspective of the contemporary clinic of the Lacanian orientation in psychoanalysis led by Jacques-Alain Miller. (shrink)

Direct-to-consumer (DTC) genetic tests (GT) enable consumers to access a wide range of GT, without involving a healthcare professional, promoting an increasing disassociation of genetics from the clinical context. This study explores, through semi-structured interviews, the experiences and attitudes of European clinical geneticists towards DTCGT. Our results indicate that the participants have limited experience of consultations with patients regarding such tests. The majority of participants stated that consumers purchased tests out of curiosity and sought a general interpretation of (...) test results by a healthcare professional. Most respondents were skeptical of the quality of tests, especially regarding their clinical utility. The participants supported the importance of medical supervision and genetic counseling in this context. Finally, most respondents considered it their duty to accept consultations concerning DTCGT results. However, due to concerns over limited time and potential downstream costs, some participants supported that a prioritization system based on guidelines would be necessary. (shrink)

Different types of clinical research are associated with different degrees of risk and with varying utility. Usually classified as therapeutic or non-therapeutic, clinical research involving children necessitates a balance between the conflicts of intrusion into a group of vulnerable subjects, and the obvious advantages which such intrusion engenders. To understand better the potential ethical dilemmas of paediatric research the author has expanded the classification of such clinical research involving children. Five types of such research--preventive research, curative (...) research, research to alleviate symptoms, studies to establish norms and baselines, and curiosity research--are discussed in the context of their ethical constraints, and the different ethical questions which confront workers operating in each of these different themes. (shrink)

Any view of equipoise faces perhaps the most radical and far-reaching objections from moral foundations. These objections hold that the equipoise requirement conflates the ethics of medical research and the ethics of clinical medicine. Once this conflation is recognized, this position holds, research can be given a new foundation on the imperative to avoid exploiting research participants. This article argues that what is novel in this critique is not as successful as its proponents claim and that the ultimate success (...) of this approach actually hinges on a version of the objection from utility. Nevertheless, this criticism highlights the limited scope of applicability of the equipoise requirement. The article concludes, therefore, by describing the outlines of what the article calls an ‘integrative approach’ to clinical trials. This approach represents one way in which the normative requirements of equipoise and the non-exploitation approach might be unified under a single, broad framework. (shrink)

Integrating large language models (LLMs) like GPT-4 into medical ethics is a novel concept, and understanding the effectiveness of these models in aiding ethicists with decision-making can have significant implications for the healthcare sector. Thus, the objective of this study was to evaluate the performance of GPT-4 in responding to complex medical ethical vignettes and to gauge its utility and limitations for aiding medical ethicists. Using a mixed-methods, cross-sectional survey approach, a panel of six ethicists assessed LLM-generated responses to (...) eight ethical vignettes.The main outcomes measured were relevance, reasoning, depth, technical and non-technical clarity, as well as acceptability of GPT-4’s responses. The readability of the responses was also assessed. Of the six metrics evaluating the effectiveness of GPT-4’s responses, the overall mean score was 4.1/5. GPT-4 was rated highest in providing technical (4.7/5) and non-technical clarity (4.4/5), whereas the lowest rated metrics were depth (3.8/5) and acceptability (3.8/5). There was poor-to-moderate inter-rater reliability characterised by an intraclass coefficient of 0.54 (95% CI: 0.30 to 0.71). Based on panellist feedback, GPT-4 was able to identify and articulate key ethical issues but struggled to appreciate the nuanced aspects of ethical dilemmas and misapplied certain moral principles.This study reveals limitations in the ability of GPT-4 to appreciate the depth and nuanced acceptability of real-world ethical dilemmas, particularly those that require a thorough understanding of relational complexities and context-specific values. Ongoing evaluation of LLM capabilities within medical ethics remains paramount, and further refinement is needed before it can be used effectively in clinical settings. (shrink)

A screening test for more than 50 cancers at earlier stages would strike many as a godsend. Such a test would promise, prima facie, to save 160,000 lives annually from a premature death from cancer, reduce the intensity of medical treatment, and reduce social costs. In brief, this is what is promised by the Galleri test. We will delineate those claims in greater detail and critically assess them from medical, economic, and ethical perspectives. We conclude, with many others, that this (...) test lacks clinical validity and clinical utility. In addition, annual public funding of $100 billion for this test would be socially unaffordable; the opportunity costs would be unacceptable for both ethical and economic reasons. Further, the least well off with respect to cancer care would be made worse off if this test were publicly funded for everyone over the age of fifty. (shrink)

The Clinical Pastoral Education (CPE) model forthe provision of spiritual care represents theemergence of a secularized professionalpractice from a religiously-based theologicalpractice of chaplaincy. The transformation ofhospital chaplaincy into “spiritual careservices” is one means by which religioushealthcare ministry negotiates modernity, inthe particular forms of the secular realm ofbiomedicine and the pluralism of thecontemporary United States healthcaremarketplace. “Spiritual” is a labelstrategically deployed to extend the realm ofrelevance to any patient's “belief system,”regardless of his or her religious affiliation.“Theological” language is recast as (...) a tool forconceptualizing the “spiritual lens.” Suchmoves transform chaplaincy from a peripheralservice, applicable only to the few “religious”patients, into an integral element of patientcare for all. Such a secularized professionalpractice is necessary to demonstrate therelevance and utility of spiritual care for allhospital patients in an era of cost-containmentpriorities and managed care economics. (shrink)

Opportunities for practical, hospital-based training in those skills demanded by clinical ethics consultation (CEC) have been limited. Given the number of individuals who provide part-time CEC, greater access to condensed, practical training such as the clinical ethics immersion course offered by the Washington Hospital Center, is necessary.Two participants in the initial cohort evaluate their CE training at a busy, urban referral center, exploring prior expectations, perceptions of its utility and suggestions for improvement. Such training will prove valuable (...) not only for bioethicists who lack practical CEC experience “at the bedside” but also for ethics consultants whose ethics services have a low consult volume who wish to sharpen their skills. (shrink)

Although DNA microarrays are now widely used in research settings, they have been slow to penetrate clinical practice in spite of their apparent advantages. This is due to the very different requirements for a clinical test in contrast to a research tool, and to a strict necessity for demonstrated clinical utility. There is a clear differentiation between two types of DNA array tests: “genomic” diagnostics, developed to ascertain the presence or absence of mutations, deletions or duplications, (...) and for which clinical evidence is already established, and tests using expression profiling for prognosis or predictive purposes, in which case the clinical correlate must be proven. Most array diagnostics currently used belong, understandably, to the “genomic” variety. It is to be expected that future improvements in tailored technology, as well as a logical trend towards measuring an ever‐increasing number of parameters, will ensure an important diagnostic role for DNA arrays in the coming decade. BioEssays 29:699–705, 2007. © 2007 Wiley Periodicals, Inc. (shrink)

The aim of this article is to analyse the contemporary ‘futility discourse’ from a constructivist perspective. I will argue that bioethics discourse typically disregards the con text from which controversies emerge and the processes that inform and constrain such discourse. Constructivists have argued that scientific knowledge is expressive of the dominant paradigm within which a scientific community is working. I will outline an analysis of ‘medical futility’ as a construction of biomedical and bioethical communities (and their respective paradigms). I will (...) trace the emergence and utilization of futility in the literature. My analysis of the context (i.e. the historical circumstances, the particular actors involved) within which the futility discourse emerged suggests that medical futility was constructed, in part, as a means of enhancing physician domination of a context wherein medical authority was threatened. The actors in this debate express widely divergent frameworks of ‘the good’, arguing from distinctive representations of moral agency. At times, this controversy has been argued from incommensurate moral horizons wherein the discussants debate incomparable problems. This discussion is related to a study of the ‘practice’ of futility in the clinical context. Further studies on the construction of bioethical problems are a necessary condition for supporting the truth claims of bioethical arguments. (shrink)

Some early phase clinical studies of candidate HIV cure and remission interventions appear to have adverse medical risk–benefit ratios for participants. Why, then, do people participate? And is it ethically permissible to allow them to participate? Recent work in decision theory sheds light on both of these questions, by casting doubt on the idea that rational individuals prefer choices that maximise expected utility, and therefore by casting doubt on the idea that researchers have an ethical obligation not to (...) enrol participants in studies with high risk–benefit ratios. This work supports the view that researchers should instead defer to the considered preferences of the participants themselves. This essay briefly explains this recent work, and then explores its application to these two questions in more detail. (shrink)

An important measure of the validity and utility of basic behavioral research is the extent to which it can be applied in real life. Basic research on behavioral momentum and the model unifying choice and resistance to change (Nevin & Grace 1999) has stimulated the development of behavioral technologies aimed at increasing the persistence of adaptive behavior and decreasing maladaptive choices.

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, (...) class='Hi'>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)

The translational research community, in general, and the Clinical and Translational Science Awards (CTSA) community, in particular, share the vision of repurposing EHRs for research that will improve the quality of clinical practice. Many members of these communities are also aware that electronic health records (EHRs) suffer limitations of data becoming poorly structured, biased, and unusable out of original context. This creates obstacles to the continuity of care, utility, quality improvement, and translational research. Analogous limitations to sharing (...) objective data in other areas of the natural sciences have been successfully overcome by developing and using common ontologies. This White Paper presents the authors’ rationale for the use of ontologies with computable semantics for the improvement of clinical data quality and EHR usability formulated for researchers with a stake in clinical and translational science and who are advocates for the use of information technology in medicine but at the same time are concerned by current major shortfalls. This White Paper outlines pitfalls, opportunities, and solutions and recommends increased investment in research and development of ontologies with computable semantics for a new generation of EHRs. (shrink)

We read with interest Dominic Wilkinson’s article “Frailty Triage: Is Rationing Intensive Medical Treatment on the Grounds of Frailty Ethical?” on the utility of the Clinical Frailty Score in...

The paper is a record of a debate which took place between a group of clinicians and the author concerning a clinical trial of a drug supposed to postpone the time when HIV-patients develop AIDS. A problem with the trial was that on available (inconclusive) evidence it appeared that one patient out of 500 was killed by the drug. The question raised was whether, in view of this evidence, it was morally defensible to go on with the trial. The (...) discussion came to involve general topics such as the appropriate role of the ideal of autonomy as well as more particular topics of quantitative and qualitative risk assessments. The main thrust of the argument is that different conceptions of rationality may provide rationales of conflicting clinical decisions. Philosophy matters to medicine. Keywords: autonomy, equipoise, hazards, the Helsinki Declaration, maximizing expected utility, potential benefits, rationality, risk assessment CiteULike Connotea Del.icio.us What's this? (shrink)

Over the past decade, umbilical cord blood (UCB) has routinely been used as a source of haematopoietic stem cells for allogeneic stem cell transplants in the treatment of a range of malignant and non-malignant conditions affecting children and adults. UCB banks are a necessary part of the UCB transplant program, but their establishment has raised a number of important scientific, ethical and political issues. This paper examines the scientific and clinical evidence that has provided the basis for the establishment (...) of UCB banks. We also discuss the major ethical issues that UCB banks raise, including ownership of cord blood, processes for obtaining consent for its collection and storage, and confidentiality. Finally, we review other concerns about commercial non-altruistic banking, including concerns about social justice, equity of access and equity of care. (shrink)

Within the evidence-based medicine construct, clinical expertise is acknowledged to be both derived from primary experience and necessary for optimal medical practice. Primary experience in medical practice, however, remains undervalued. Clinicians’ primary experience tends to be dismissed by EBM as unsystematic or anecdotal, a source of bias rather than knowledge, never serving as the “best” evidence to support a clinical decision. The position that clinical expertise is necessary but that primary experience is untrustworthy in clinical decision-making (...) is epistemically incoherent. Here we argue for the value and utility of knowledge gained from primary experience for the practice of medicine. Primary experience provides knowledge necessary to diagnose, treat, and assess response in individual patients. Hierarchies of evidence, when advanced as guides for clinical decisions, mistake the relationship between propositional and experiential knowledge. We argue that primary experience represents a kind of medical knowledge distinct from the propositional knowledge produced by clinical research, both of which are crucial to determining the best diagnosis and course of action for particular patients. (shrink)

This paper interrogates the concept of luck in cancer diagnosis. I argue that while it might have some utility for individuals, at the clinical and research level, the concept impedes important prevention efforts and misdirects sources of blame in a cancer diagnosis. Such use, in fact, has the possibility of harming already vulnerable efforts at ameliorating social determinants of health and should therefore be eliminated from research and clinical contexts.

In _The Biology of Clinical Encounters_, Gedo utilizes recent findings in neuroscience and cognitive psychology to elaborate his conception of psychobiology and to consider its implications in clinical analysis. He pursues this challenging undertaking in several directions. He illuminates the way in which psychobiology enters into his hierarchical model of mental functioning, and goes on to examine three clinical syndromes - phobias, obsessions, and affective disturbances - in which biological considerations are particularly important. Of special note are (...) chapters examining the implications of a biological approach for clinical psychoanalysis. Gedo explores the notion of transference that grows out of attentiveness to psychobiological factors, elaborates the concept of therapeutics that follows from looking beyond mental contents, and discusses the problem of assessing clinical evidence produced by analyses informed by a psychobiological orientation. Drawing on his own analytic work of over three decades, he compares analyses conducted with a psychobiological orientation with the outcome of analyses conducted earlier in his career with a more traditional psychological approach. A stimulating introduction to the interpenetration of the biological and the psychological in clinical work, _The Biology of Clinical Encounters_ is quintessential Gedo: scholarly in conception, elegant in tone, provocative in import, and illuminating, always, of fundamental issues about the status of psychoanalysis as a science of mind. (shrink)

Pain is often used as the paradigmatic example of a phenomenal kind with a phenomenal quality common and unique to its instantiations. Philosophers have intensely discussed the relation between the subjective feeling, which unites pains and distinguishes them from other experiences, and the phenomenal properties of sensory, affective, and evaluative character along which pains typically vary. At the center of this discussion is the question whether the phenomenal properties prove necessary and/or sufficient for pain. In the empirical literature, sensory, affective, (...) and evaluative properties have played a decisive role in the investigation of psychophysical correspondence and clinical diagnostics. This paper addresses the outlined philosophical and empirical issues from a new perspective by constructing a multidimensional phenomenal space for pain. First, the paper will construe the phenomenal properties of pains in terms of a property space whose structure reflects phenomenal similarities and dissimilarities by means of spatial distance. Second, philosophical debates on necessary and sufficient properties are reconsidered in terms of whether there is a phenomenal space formed of dimensions along which all and only pains vary. It is concluded that there is no space of this kind and, thus, that pain constitutes a primitive phenomenal kind that cannot be analyzed entirely in terms of its varying phenomenal properties. Third, the paper addresses the utility of continued reference to pain and its phenomenal properties in philosophical and scientific discourses. It is argued that numerous insights into the phenomenal structure of pain can be gained that have thus far received insufficient attention. (shrink)

De Marco et al 1 argue that the standard account of medical ‘invasiveness’ (as ‘incision’ or ‘insertion’) fails to capture three aspects of its existing use, namely that invasiveness can come in degrees, often depends on features of alternative medical interventions and can be non-physical. They propose a new schematic account that suggests that medical interventions can possess ‘basic invasiveness’ (which can come in degrees and of which they suggest at least two types: physical and mental), and ‘threshold invasiveness’ which (...) can depend on the alternatives a specific intervention is being compared with. While we agree that the standard account of invasiveness fails to capture existing use and are supportive of their aim, here we express scepticism about the practical utility of De Marco et al ’s revised account. Our scepticism concerns the application of De Marco et al’s revised account in the narrow context of clinician–patient communication and deliberation about medical interventions within clinical practice, which we see as a crucial context for its use. While De Marco et al do not specify the contexts in which their revised account could be used, we assume from their discussion of treatment interventions (e.g. non-invasive prenatal testing, ventilation) and their comparison to ‘more or less invasive’ options, that at least one of the purposes in mind for …. (shrink)

What follows raises objections to some arguments that claimthat a principle of applicability of ordinary pain talkconstrains developments in the pain sciences. A more apt pictureof lay use of pain language shows its non-theoretic character.Since instrumentalism and eliminativism are philosophical viewsabout the status of theories of pain, neither is a threatto clinical use of standard pain lingo. Perfected pain theoryis likely to enhance and improve pain language in clinicalsettings, should such theory find its way into popular ideasand talk of (...) pain. (shrink)

The term “therapeutic misconception” was coined in 1982 by Paul Appelbaum, Loren Roth, and Charles Lidz. Appelbaum and his colleagues interviewed participants in several psychiatric studies, including a drug trial with a placebo control arm. Appelbaum's group found that many people were unaware of the differences between participating in a study and receiving treatment in the clinical setting. Rather than understanding these differences, study participants tended to believe that therapy and research were governed by the same primary goal: to (...) advance the individual patient's best interests. Appelbaum's group labeled this mistaken belief the therapeutic misconception. (shrink)

This paper examines the role of clinical practitioners and clinical researchers internationally in establishing the utility of harm-reduction approaches to substance use. It thus illustrates the potential for clinicians to play a pivotal role in health promoting structural interventions based on harm-reduction goals and public health models. Popular media images of drug use as uniformly damaging, and abstinence as the only acceptable goal of treatment, threaten to distort clinical care away from a basis in evidence, which (...) shows that some ways of using drugs are far more harmful than others and that punitive approaches and insistence on total abstinence as the only goal of treatment often increases the harms of drug use rather than reducing drug use. Therefore the leadership and scientific authority of clinicians who understand the health impact of harm-reduction strategies is needed. Through a review of harm-reduction interventions in Canada, the United Kingdom, the United States, Australia, Switzerland, and the Netherlands, we identify three ways that clinicians have helped to achieve a paradigm shift from punitive approaches to harm-reduction principles in clinical care and in drug policy: through clinical research to provide data establishing the effectiveness and feasibility of harm-reduction approaches, by developing innovative clinical programmes that employ harm reduction, and thereby changing the standard of care to include routine use of these evidence-based approaches in their practices. We argue that through promotion of harm-reduction goals and methods, clinicians have unique opportunities to improve the health outcomes of vulnerable populations. (shrink)

The recent Ebola virus disease outbreak in Western African countries has raised questions regarding the feasibility of adopting conventional trial designs such as randomized controlled trials for conducting experimental trials in the midst of a fatal epidemic. In the context of Ebola ça Suffit trial conducted in Guinea for testing the efficacy and effectiveness of rVSV–ZEBOV, a candidate vaccine, I argue that the trial design and the methodologies adopted for the trial have been rightly chosen for their ethical appropriateness and (...) social utilities rather than only epistemic advantages. In this paper, I propose and defend the view that in varying scientific research contexts, it is entirely legitimate that non-epistemic values may be prioritized over epistemic considerations. Two vital methodological choices scientists should make while designing a clinical trial are: the choice of appropriate control group and the choice of appropriate randomization. Given this background, I show that the choice of delayed vaccination arm as the control group over placebo control group and the choice of cluster randomization over individually controlled randomization for conducting Ebola ça Suffit trial are perfect instances of such a scenario where addressing social and ethical issues have been justifiably prioritized over epistemic values so that the research in a specific scientific context could be conducted in a socially relevant manner. (shrink)

The philosophy of Aristotle and its impact on the process of empirical scientific inquiry has been substantial. The influence of the clarity and orderliness of his thinking, when applied to the acquisition of knowledge in nursing, can not be overstated. Traditional empirical approaches have and will continue to have an important influence on the development of nursing knowledge through nursing research. However, as nursing is primarily a practice discipline, the transition from empirical and syllogistic reasoning is problematic. Other types of (...) inquiry are essential in the application of nursing knowledge obtained by empirical scientific approaches and to understand how that knowledge can best be used in the care of patients. This paper reviews the strengths and limitations of syllogistic reasoning by applying it to a recently published study on temperature measurement in nursing. It then discusses possible ways that the empirical knowledge gained from that study and confirmed in its reasoning by logical analysis could be used in the daily care of critically ill patients. It concludes by highlighting the utility of broader approaches to knowledge development, including interpretative approaches and contemporary empiricism, as a way to bridge the gap between factual empirical knowledge and the practical application of that knowledge in everyday clinical nursing practice. (shrink)