IntroductionDespite the need for trained physician ethicists, fellowships in clinical ethics are limited and primarily offered to thosewho have completed a graduate degree. The standardization of credentialing for clinical ethics consultants (CECs) and the restructuring of undergraduate medical education allow innovative models to train CECs that can provide an expanded opportunity for formal ethics training at an earlier stage.MethodsAt the University of Michigan Medical School we developed, implemented, and evaluated a pre-doctoral clinical ethics fellowship program from 2017 (...) to 2019 for senior medical students, designed to meet established competencies for CECs. Consultation notes from the beginning and end of the fellowship program were randomly selected for each fellow and independently rated by two faculty ethicists who used the validated Ethics Consultation Quality Assessment Tool (ECQAT).1 Inter rater reliability and trends in scores over time were calculated.ResultsThree students successfully completed the fellowship at the University of Michigan Medical School, conducted at least 50 formal ethics consultations, and spent approximately 40 hours a week on service for a minimum of six months. All students finished the fellowship with teaching and policy development experience, first-authored peer-reviewed manuscripts, and national presentations. The fellows demonstrated improvement in their ECQAT overall holistic rating score; all ended their fellowship with a holistic score of adequate or above. There was 92 percent agreement between raters withrespect to the acceptability of the fellows’ ethics consult notes. Two fellows have taken and passed the Healthcare Ethics Consultant-Certification (HEC-C) exam offered by the American Society for Bioethics and Humanities (ASBH).ConclusionsIntegration of a pre-doctoral fellowship model that meets professional certification standards for clinical ethics consultation creates an opportunity for medical students to become trained CECs early in their career. (shrink)

For decades, Christiane Northrup has been helping women navigate their lives with grace and joy. This elegant, compact volume offers her trademark wisdom in a fresh form, filled with pointed reminders "to help you develop a deeper respect for, and connection to, your own body and its exquisite guidance system [to] create a vibrantly healthy body, mind, and spirit." Each beautifully designed black-and-white page carries a quote that touches on a topic of deep significance: everything from heart-listening to epigenetics to (...) the importance of knowing that your decisions about medical treatment are not irreversible. Examples include:You are an ever-renewing, ever-changing, ever-growing being, born with an inner guidance that helps you create and maintain vibrant health and happiness. / When faced with a dilemma, take a moment to sit with the issue. Don't rush to decide what to do. Intend to let Divine inspiration flow to you, and it will be so! The next time you get an ache or a pain, soften the area around it with compassion. Ask your body what it needs. Listen deeply for the answer. (shrink)

The fact that Ludwik Fleck drew his inspiration from medicine has been largely overlooked, with the exception of a few scholars. Although Fleck considered his ideas applicable to all sciences, he always insisted on the specificity of medicine. To illustrate the usefulness of Fleck’s concepts for the history of medicine, three main ideas developed by Fleck are applied to the historical study of diabetes mellitus : first, that different and often divergent pictures of disease coexist within a given culture; second, (...) that scientific ideas circulate between ‘esoteric’ and ‘exoteric’ circles; and third, that scientific concepts are often incommensurable. The author also suggests that Fleck’s epistemology, like other scholars’, is loaded with ethical and political consequences. However, the link between an ‘open’ epistemology and political or ethical questions is more explicit in Georges Canguilhem’s pioneering work on the normal and the pathological . Indeed, Canguilhem and Fleck’s conceptions of disease have much in common, so that we can use Canguilhem’s work to bring out the hidden ethical and political issues in Fleck’s work. (shrink)

A consumer health information system must be able to comprehend both expert and non-expert medical vocabulary and to map between the two. We describe an ongoing project to create a new lexical database called Medical WordNet (MWN), consisting of medically relevant terms used by and intelligible to non-expert subjects and supplemented by a corpus of natural-language sentences that is designed to provide medically validated contexts for MWN terms. The corpus derives primarily from online health information sources targeted to (...) consumers, and involves two sub-corpora, called Medical FactNet (MFN) and Medical BeliefNet (MBN), respectively. The former consists of statements accredited as true on the basis of a rigorous process of validation, the latter of statements which non-experts believe to be true. We summarize the MWN / MFN / MBN project, and describe some of its applications. (shrink)

American society has a history of turning to physicians during times of extreme need, from plagues in the past to recent outbreaks of communicable diseases. This public instinct comes from a deep seated trust in physician duty that has been earned over the centuries through dedicated and selfless care, often in the face of personal risks. As dangers facing our communities include terroristic events physicians must be adequately prepared to respond, both medically and ethically. While the ethical principles that govern (...) physician behavior—beneficence, nonmaleficence, autonomy, and social justice—are unchanging, fundamental doctrines must change with the new risks inherent to terroristic events. Responding to mass casualty disasters caused by terrorists, natural calamities, and combat continue to be challenging frontiers in medicine. Preparing physicians to deal with the consequences of a terroristic disease must include understanding the ethical challenges that can occur. (shrink)

Financial conflicts of interest in medical research foster deviations from research standards and evidentially lead to the suppression of research findings that are at odds with commercial interests of pharmaceutical companies. Questionable research practices prevent data from being created, made available, or given suitable recognition. They run counter to codified principles of responsible conduct of research, such as honesty, openness or respect for the law. Resulting in ignorance, misrepresentation and suspension of scientific self-correction, suppression of medical evidence in (...) its various forms is both a threat to the epistemic and the moral integrity of medical science. This paper discusses an example of the suppression of medical evidence in recent influenza research and develops a conceptual framework for the description and assessment of questionable research practices applied in research and publication processes to suppress evidence. (shrink)

La mise en garde d'un psychiatre spécialiste de l'enfance sur les dérives de l'indifférenciation sexuelle.

Advanced AI systems are rapidly making their way into medical research and practice, and, arguably, it is only a matter of time before they will surpass human practitioners in terms of accuracy, reliability, and knowledge. If this is true, practitioners will have a prima facie epistemic and professional obligation to align their medical verdicts with those of advanced AI systems. However, in light of their complexity, these AI systems will often function as black boxes: the details of their (...) contents, calculations, and procedures cannot be meaningfully understood by human practitioners. When AI systems reach this level of complexity, we can also speak of black-box medicine. In this paper, we want to argue that black-box medicine conflicts with core ideals of patient-centered medicine. In particular, we claim, black-box medicine is not conducive for supporting informed decision-making based on shared information, shared deliberation, and shared mind between practitioner and patient. (shrink)

We propose a principle of sustainability to complement established principles used for justifying healthcare resource allocation. We argue that the application of established principles of equal treatment, need, prognosis and cost-effectiveness gives rise to what we call negative dynamics: a gradual depletion of the value possible to generate through healthcare. These principles should therefore be complemented by a sustainability principle, making the prospect of negative dynamics a further factor to consider, and possibly outweigh considerations highlighted by the other principles. We (...) demonstrate how this principle may take different forms, and show that a commitment to sustainability is supported by considerations internal to the ethical principles already guiding healthcare resource allocation. We also consider two objections. The first of these, we argue, is either based on implausible assumptions or begs the question, whereas the second can be adequately accommodated by the principle we propose. (shrink)

The anti-tuberculosis BCG vaccine was conceived and developed between 1905 and 1921 at Pasteur Institutes in France. Between 1921 and A. Calmette’s death in 1933, the vaccine went through a first period of national and international production and distribution for its use in humans. In France these activities were exclusively carried out by Calmette and his collaborators at the Pasteur Institute in Paris. Initially improvised production in a small room in the cellar gave way in 1931 to the construction of (...) the spacious and magnificent ‘New laboratories for research on tuberculosis and the preparation of the BCG’ within the premises of the Pasteur Institute. Presentation and image-building of the vaccine in France insisted on the fact that the BCG was not a commercial specialty but distributed free of charge. The technical monopoly of its production nevertheless lay with the Paris Pasteur Institute and standardization of scientific proof of safety, efficacy and stability was dominated by that Institute in France. In contrast, the international production and distribution of the vaccine was entrusted and transferred, free of charge, to trustworthy laboratories outside France. Multiplication of producers and users led to an increased need for standardization. For this process the analysis distinguishes between the standardization of scientific proof concerning safety, efficacy and stability of the vaccine and standardization of its medical uses. Whereas standardization was rather successful in the inter-war period in France, the international efforts remained rather unsuccessful. Only after world war II under Scandinavian leadership and in the context of mass vaccination programs supported by the WHO and UNICEF was the international standardization effectively implemented and succeeded at least to some extend. (shrink)

Military physicians are often perceived to be in a position of ‘dual loyalty’ because they have responsibilities towards their patients but also towards their employer, the military institution. Further, they have to ascribe to and are bound by two distinct codes of ethics, each with its own set of values and duties, that could at first glance be considered to be very different or even incompatible. How, then, can military physicians reconcile these two codes of ethics and their distinct professional/institutional (...) values, and assume their responsibilities towards both their patients and the military institution? To clarify this situation, and to show how such a reconciliation might be possible, we compared the history and content of two national professional codes of ethics: the Defence Ethics of the Canadian Armed Forces and the Code of Ethics of the Canadian Medical Association. Interestingly, even if the medical code is more focused on duties and responsibility while the military code is more focused on core values and is supported by a comprehensive ethical training program, they also have many elements in common. Further, both are based on the same core values of loyalty and integrity, and they are broad in scope but are relatively flexible in application. While there are still important sources of tension between and limits within these two codes of ethics, there are fewer differences than may appear at first glance because the core values and principles of military and medical ethics are not so different. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Artificial Minds and the Dilemma of Personal IdentityChristian Coseru (bio)Artificial You: AI and the Future of Your Mind. By Susan Schneider. Princeton: Princeton University Press, 2019.I. IntroductionAll diurnal organisms are stirred to action by light, but as entomologists have long known, for nocturnal insects the pull of its radiance can also spell doom. The image of a moth drawn to flame is suggestive of the sort of self-destructive behavior (...) that poets have long used to maximum rhetorical effect: "Thus had the candle singed the moth" proclaims Portia in the Merchant of Venice, pitying the fate that befell Arragon. The deceptive lure of artificial lights, however, is no longer mere fodder for the poetic imagination. Ecologists are warning us that species accustomed to navigating by moon or starlight, from beetles to seals and sea turtles, are getting confused, or worse.1 And medical science is beginning to establish a link between night-time light exposure and various sleep and metabolic disorders.2 Yet our Promethean ingenuity is a sight to behold: fueled by illumination tropes as metaphors for awareness and understanding, our mastery of light and of the electromagnetic wave spectrum has brought forth technologies, from CT scans and electromicrography to myoelectric sensors and solid-state lighting, that inspire utopian visions of genetically engineered and neurally enhanced post-humans alongside dystopian fantasies of runaway cyborgs. Among these technologies, AI stands out as the shiny new object commanding our attention.The future envisioned as a result of these technological advancements now includes the prospect of artificial minds, minds that, if they were to come anywhere close to resembling ours, let alone to surpassing human intelligence, would pose serious existential and ethical challenges for humanity. Or so the story goes, if Susan Schneider's compelling foray into AI research is any indication. Indeed, Artificial You: AI and the Future of Your Mind (Schneider 2019) offers a philosophically savvy investigation of the debates that animate much of the contemporary fascination with the prospect of machine intelligence, which by some of the more optimistic [End Page 281] measures could be achieved within the lifetime of most millennials.3 As books aimed at a general audience pondering the promises and perils of superintelligent AI go, Artificial You succeeds precisely where most others falter: it brings conceptual clarity to often vague and nebulous claims by techno optimists about the impending emergence of consciousness from computational complexity, while at the same time offering a sober reminder that the technology underlying, say, artificial neural networks is far more advanced than most AI skeptics realize.I will not address Schneider's survey of the state of the art in AI research, which is succinct, informative, and for the most part illustrative of the transhumanist ethos she appears to embrace. Instead, I will focus on the problem of personal identity and the seemingly insurmountable challenges it raises for the prospect of radical human enhancement and synthetic consciousness. Specifically, I will argue that conceptions of personal identity rooted in psychological continuity akin to those proposed by Parfit and the Buddha may not provide the sort of grounding that many transhumanists chasing the dream of life extension think that they do if they rest upon ontologies that assume an incompatibility between identity and change. I will also suggest that process ontologies that take change to be primary, such as those that align with contemporary systems biology, offer a better way out of the personal identity dilemma. But the solution in this case, which regards biological organisms as processes rather than things, may constrain the possibility of biologically inspired superintelligent aliens (BISAs), which Schneider (following Bostrom 2014) posits as possibly the most common form of (extraterrestrial) superintelligence in the universe.II. Enhancement Beyond RecognitionPerhaps the central leitmotif of transhumanism is the idea of enhancement by means of current technologies such as genetic engineering and information technology as well as future ones such as nanotechnology and artificial intelligence. The range of enhancement options includes the extension of the human lifespan, the elimination of disease, and most importantly the augmentation of human intellectual, physical, and affective capacities (Bostrom 2003b). Further down the line, enhancement may move beyond merely augmenting existing... (shrink)

ArgumentUsing the example of the anti-tuberculosis vaccine BCG during the 1920s and 1930s, this article asks how a labile laboratory-modified bacteria was transformed into a genuine standard vaccine packaged and commercialized as a pharmaceutical product. At the center of the analysis lies the notion of standardization inquiring why and how a local laboratory process with standard operating procedures reached its limits and was transformed when the product faced international distribution. Moving from Paul Ehrlich's initial technological notion ofWertbestimmungreferring to a practice (...) physiologically testing the effects of ill-defined antitoxins, the concept of standardization is extended to pharmaceutical and economical meanings implying quality control for biological therapeutic agents produced by a variety of industrial entrepreneurs. Following the request for product uniformity, two ways to maintain levels of compatibility and commonality are depicted opposing SOPs and end-product control. Furthermore, standardization is understood as a spiral, never ending process where progressive transformation of the vaccine in its production and medical uses periodically recreated the necessity of standardization. Developments analyzed are thus understood as a stabilization process aligning laboratory settings, products, and practices with medical theories and practices through technical, bureaucratic, and organizational systems. A paradox of the analysis is that standardization as a historical phenomenon and moment in the history of drug development was initially linked to a problem of under-determination of what was to be standardized and to a knowledge gap before it could become a central concept for quality control. (shrink)

Perceptions are often merely regarded as the basic elements of knowledge. They have, however, a complex structure of their own and are far from being elementary. My paper will analyze two basic patterns of perception and some of the resulting medical implications. Most basically, all object perception is characterized by a mixture of knowledge and ignorance (Husserl). Perception essentially perceives with inner and outer horizons, brought about by the kinesthetic activity of the perceiving subject (Sartre). This first layer of (...) perceptual reality, the world of open perceptions, is the inescapable background for every rationality, every value, every existence (Merleau-Ponty). On an epistemological level a characteristic change of perceptual patterns in medicine was introduced by pathological anatomy (Foucault). The reference of medical perception to the dead body created the new possibility of absolute perception, allowing for more precise medical interventions, but at the same time coming into conflict with the open structures of ordinary, non-scientific perception patterns in everyday life. On the basis of these distinctions, an analysis of the different perceptual patterns in medicine becomes possible. Such an analysis would be the task of a sub-field in medical philosophy that could be called medical aesthetics having as its goal an art of perception understood as a technique of adequately applying different perceptual patterns in medical practice. (shrink)

In response to recent concerns about the overmedication of children, this paper considers ethical and conceptual issues that arise in the issue of when children who are diagnosed with attention deficit hyperactivity disorder should be given stimulants such as the psychotropic drug Ritalin as part of their treatment. There is considerable resistance and worry about the possibility of overmedication. This is linked to the worry that the diagnosis of ADHD is overused, and the paper considers some reasons to worry about (...) the overuse of the diagnosis itself. The paper then focuses on the resistance to the use of drugs, which is particularly strong for children in the gray area of diagnosis, where it is dubious whether the children really meet the strict diagnostic criteria. The reasons behind such resistance are often not well articulated, so part of the task of the paper is spell out what they might be. The reasons are given the following labels: side effects, unnaturalness, profit motives, thought control, competitiveness, and doctors' power. The paper ends in taking the polemical position that while there is some legitimate concern about possible short and long term side effects of children taking psychotropic drugs, the other reasons for resistance are not well‐founded. (shrink)

In this article, I will argue in favor of both the ethical and epistemological utility of explanations in artificial intelligence -based medical technology. I will build on the notion of “explicability” due to Floridi, which considers both the intelligibility and accountability of AI systems to be important for truly delivering AI-powered services that strengthen autonomy, beneficence, and fairness. I maintain that explicable algorithms do, in fact, strengthen these ethical principles in medicine, e.g., in terms of direct patient–physician contact, as (...) well as on a longer-term epistemological level by facilitating scientific progress that is informed through practice. With this article, I will therefore attempt to counter arguments against demands for explicable AI in medicine that are based on a notion of “whatever heals is right.” I will elucidate my elaboration on the positive aspects of explicable AI in medicine as well as by pointing out risks of non-explicable AI. (shrink)

The human body and its parts are widely perceived as matters beyond commercial usage. This belief is codified in several national and European documents. This so-called ‘no-property rule’ is held to be the default position across the countries of the European Union. However, a closer look at the most pertinent national and European documents, and also current practices in the field, reveals a gradual model of commercialisation of human tissue. In particular, we will argue that the ban on commercialisation of (...) body material is not as strict as it may appear at first sight, leaving room for the commercial practice of tissue procurement and transfer. We argue for more transparent information for patients and tissue donors, an intensified ethical debate on commercialisation practices, and a critical review of current normative principles. (shrink)

In response to Koplin and Wilkinson, I argue, first, that the uncertain clinical prospects of human-pig chimera based transplantation makes the reason to spend resources for clarifying whether such practice might imply serious ethical breach due to enhanced cognitive capacities of the chimeras rather weak. T he benefits of further pursuing this avenue of research is so uncertain, so that taking even very unclear risks of serious ethical breach is not worth the price in terms of spent resources, and therefore (...) only limited resources should be spent to clarify such risk before the project is abandoned due to unacceptable risks. Second, I argue that as there are some reason to pursue this avenue further, the analogy to the notion of halting all farming of larger animals for food does not hold up. The reason is that we do not need to probe any further any comparable risk to know that such farming practices should be halted. A fundamental underlying issue to the question discussed by Koplin and Wilkinson1 in this paper is formulated when they write: > We should therefore be confident that human-pig chimeras would lack morally relevant cognitive capacities before setting out to use them as a source of transplantable human organs. This leaves open the question of how confident …. (shrink)

BackgroundAt the start of 2021, oncologists lacked the necessary scientific knowledge to adapt their clinical practices optimally when faced with cancer patients refusing or reluctant to be vaccinated against COVID-19, despite the marked vulnerability of these patients to severe, and even fatal forms of this new viral infectious disease. Oncologists at Foch Hospital were confronted with this phenomenon, which was observed worldwide, in both the general population and the population of cancer patients.MethodsBetween April and November 2021, the Ethics and Oncology (...) Departments of Foch Hospital decided to investigate this subject, through an empirical and interdisciplinary study in bioethics. Our scientific objective was to try to identify and resolve the principal bio-ethical issues, with a view to improving clinical practices in oncology during future major pandemics of this kind, from a highly specific bio-ethical standpoint. We used a mainly qualitative methodological approach based on questionnaires and interviews.ResultsIn April 2021, 29 cancer patients refused or were reluctant to be vaccinated. Seventeen of these patients said that making vaccination mandatory would have helped them to accept vaccination. In October 2021, only 10 cancer patients continued to maintain their refusal. One of the main reasons for the decrease in refusals was probably the introduction of the “pass sanitaire” in July 2021, which rendered vaccination indispensable for many activities. However, even this was not sufficient to convince these 10 cancer patients.ConclusionWe identified a key bio-ethical issue, which we then tried to resolve: vaccination policy. We characterized a major tension between “the recommendation of anti-COVID-19 vaccination” and “free will”, and the duty to “protect each other”. Mandatory vaccination, at least in France, could resolve this tension, with positive effects on quality of life, or survival, in cancer patients initially refusing or reluctant to be vaccinated, but only if collective and individual scales are clearly distinguished. (shrink)

The Swedish solution to the legal handling of professional conscientious refusal in healthcare is described. No legal right to conscientious refusal for any profession or class of professional tasks exists in Sweden, regardless of the religious or moral background of the objection. The background of this can be found in strong convictions about the importance of public service provision and related civic duties, and ideals about rule of law, equality and non-discrimination. Employee's requests to change work tasks are handled on (...) a case-by-case basis within the frames of labour law, ensuring full voluntariness, and also employer's privilege regarding the organisation and direction of work, and duties of public institutions to provide services. Two complicating aspects of this solution related to the inclusion of ‘alternative medical’ service providers in a national health service, and professional insistence on conscientious refusal rights to accept legalised assisted dying are discussed. The latter is found to undermine the pragmatic reasons behind recent attempts by prolife groups to challenge the Swedish solution related to legal abortion in courts. (shrink)

BackgroundValue sensitivity – the ability to recognize value-related issues when they arise in practice – is an indispensable competence for medical practitioners to enter decision-making processes related to ethical questions. However, the psychological competence of value sensitivity is seldom an explicit subject in the training of medical professionals. In this contribution, we outline the traditional concept of moral sensitivity in medicine and its revised form conceptualized as value sensitivity and we propose an instrument that measures value sensitivity.MethodsWe developed (...) an instrument for assessing the sensitivity for three value groups in a four step procedure: 1) value identification ; 2) value representation ; 3) vignette construction and quality evaluation ; and 4) instrument validation by comparing nursing professionals with hospital managers.ResultsWe find that nursing professionals recognize and ascribe importance to principle-related issues more than professionals from hospital management. The latter are more likely to recognize and ascribe importance to strategy-related issues.ConclusionsThese hypothesis-driven results demonstrate the discriminatory power of our newly developed instrument, which makes it useful not only for health care professionals in practice but for students and people working in the clinical context as well. (shrink)

The practice and development of modern medicine requires large amounts of data, particularly in the domain of cancer. The future of personalized medicine lies neither with “genomic medicine” nor with “precision medicine”, but with “data medicine”. The establishment of this DM has required far-reaching changes, to establish four essential elements connecting patients and doctors: biobanks, databases, bioinformatic platforms and genomic platforms. The “transformation” of scientific research areas, such as genetics, bioinformatics and biostatistics, into clinical specialties has generated a new vision (...) of care. Molecular tumor boards are one response to these changes and are now providing better access to next-generation sequencing and new cancer treatments to patients with inoperable or metastatic cancers, and those for whom the usual treatment has failed. However, MTB face a crucial ethical challenge: maintaining and improving the trust of patients, clinicians, researchers and industry in academic medical centers supported by private or public funding rather than providing genetic data directly to private companies. We believe that, in this era of DM, appropriate modern digital communication networks will be required to maintain this trust and to improve the organization and effectiveness of the system. There is, therefore, a need to reconsider the form and content of informed consent documents at all academic medical centers and to introduce dynamic and electronic informed consent. (shrink)

Many studies have emphasized the importance of medical, insurance, and workplace systems treating individuals fairly in work disability prevention and return-to-work. However, ethical theories and perspectives from these different systems are rarely discussed in relation to each other, even though in practice these systems constantly interact. This paper explores ethical theories and perspectives that may apply to the WDP–RTW field, and discusses these in relation to perspectives attributed to dominant stakeholders in this field, and to potential differences in different (...) jurisdictional contexts. Literature was sought primarily in biomedical ethics, business ethics, and public administration ethics. In biomedical ethics, four ethical principles are dominant: autonomy, beneficence, nonmalevolence, and justice. Business ethics involve theories on Corporate Social Responsibility, social contracts, and organizational justice. Public administration ethics focus on constitutional theory, citizenship, social equity, virtue, and public interest. Several concepts were identified as relevant for ethical analyses in the WDP–RTW field, including justice; individual autonomy; nonmalevolence; economic and social responsibility; and social contracts. These concepts provide a vocabulary that may be used to analyze stakeholders’ actions and interactions in RTW processes. It was also noted how the power balance between stakeholders will influence which ethical perspectives will influence RTW. Jurisdictional differences that influence RTW processes with regard to stakeholder responsibilities were identified, as well as varying beliefs as to who is the client in different compensation systems. A social contractual approach may inform an analysis of cultural and legal differences. (shrink)

In an increasingly data-driven age of medicine, do companies that offer genetic testing directly to patients represent an important part of personalising care, or a dangerous threat to privacy? Should we celebrate this new mechanism of patient involvement, or fear its implications?The Universities of Oxford and Cambridge addressed these issues in the 10th annual Medical Ethics Varsity Debate, through the motion: “This House Regrets the Rise of Direct-to-Consumer Genetic Testing”. This article summarises and extends key arguments made in the (...) debate, exploring the impacts of such genetic testing on both the individual patient and broader society, with special consideration as to whether companies can ever truly guarantee anonymity of genetic data. (shrink)

In an increasingly data-driven age of medicine, do companies that offer genetic testing directly to patients represent an important part of personalising care, or a dangerous threat to privacy? Should we celebrate this new mechanism of patient involvement, or fear its implications?The Universities of Oxford and Cambridge addressed these issues in the 10th annual Medical Ethics Varsity Debate, through the motion: “This House Regrets the Rise of Direct-to-Consumer Genetic Testing”. This article summarises and extends key arguments made in the (...) debate, exploring the impacts of such genetic testing on both the individual patient and broader society, with special consideration as to whether companies can ever truly guarantee anonymity of genetic data. (shrink)

We consider the implications for the ethical evaluation of research programs of two fundamental changes in the revised research ethical guideline of the Council for International Organizations of Medical Sciences. The first is the extension of scope that follows from exchanging “biomedical” for “health‐related” research, and the second is the new evaluative basis of “social value,” which implies new ethical requirements of research. We use the example of antibiotic resistance interventions to explore the need to consider the instances of (...) what we term the pragmatic risks of such interventions to evaluate the social value of certain kinds of health‐related research. These (pragmatic) risks severely threaten the social value of interventions in every area where human and social responses significantly impact on their effectiveness. Thus, the social value of health‐related research needed to demonstrate its effectiveness depends on the extent and successful management of such risks. Research designed to take into account the management of pragmatic risks also gives rise to similar types of risks, and the potential for social value in light of those risks needs to be considered in ethical reviews based on the new guidelines. We argue that, to handle this new expanded task, the international system of research ethical review addressed by the guidelines needs institutional development. (shrink)

We argue that the dead donor rule, which states that multiple vital organs should only be taken from dead patients, is justified neither in principle nor in practice. We use a thought experiment and a guiding assumption in the literature about the justification of moral principles to undermine the theoretical justification for the rule. We then offer two real world analogues to this thought experiment, voluntary active euthanasia and capital punishment, and argue that the moral permissibility of terminating any patient (...) through the removal of vital organs cannot turn on whether or not the practice violates the dead donor rule.Next, we consider practical justifications for the dead donor rule. Specifically, we consider whether there are compelling reasons to promulgate the rule even though its corresponding moral principle is not theoretically justified. We argue that there are no such reasons. In fact, we argue that promulgating the rule may actually decrease public trust in organ procurement procedures and medical institutions generally – even in states that do not permit capital punishment or voluntary active euthanasia.Finally, we examine our case against the dead donor rule in the light of common arguments for it. We find that these arguments are often misplaced – they do not support the dead donor rule. Instead, they support the quite different rule that patients should not be killed for their vital organs. (shrink)

Two essential periods may be identified in the early stages of the history of vitamin D-resistant rickets. The first was the period during which a very well known deficiency disease, rickets, acquired a scientific status: this required the development of unifying principles to confer upon the newly developing science of pathology a doctrine without which it would have been condemned to remain a collection of unrelated facts with very little practical application. One first such unifying principle was provided by the (...) notion of hygiene; while the blanket explanations provided by this notion alone were much too general to enable rickets to achieve scientific status, it did point out the need to look for specific external causes for the disease and to examine the life-style and dietary habits of the patients. The second phase of the conceptualization of the disease was the assumption of a specific cause — that is, using concepts developed in the area of infectious diseases. This was made possible by fundamental similarities between deficiency and infectious diseases, in spite of their apparent differences. Both types of illness have some of the characteristics of what Georges Canguilhem calls the ontological representation of disease as opposed to dysharmonic representations, which primarily concern the endocrine diseases. It is precisely this shift from one to the other manner of perceiving ill health that enabled the identification of the vitamin D-resistant rickets. Conceptualization of the notion of vitamin D resistancy required that the conditions causing the disease be looked for within the organism rather than outside it; this was thus the first time that endocrine concepts were applied to studying the physiology of vitamin D.The history of resistant rickets therefore represents an interesting model for understanding the growth of biomedical knowledge. It allows the development of a number of more general ideas on the question of the relationship between biology and medicine and on the thorny problem of specificity in medical thinking. As far as this topic is concerned it can be seen that there was an ongoing exchange between medical and biological thinking during the initial period up until 1937, and that one could deny any such specificity in medical thinking during this same period. Albright, for example, used human diseases as spontaneously produced models for experimental biology. It was also more feasible for an experimental biologist to administer toxic doses than for a clinician to do so.What, then, if any, is the place of the specificity of medical thinking in this history? The fact that medicine is characterized not only by it ccognitive content78 but also by its final aim, which is to restore health, makes it necessary to take factors other than objective knowledge into consideration. This is particularly evident in two aspects of medicine, therapeutics and nosology, and in approaching the notion of pathological individuality.Therapeutic activity has a largely empirical approach. Many drugs, such as cod-liver oil, were discovered empirically. Treatment often in the past, and still now, has proceeded by trial and error, upon no established theoretical basis. At this level the relationship between biology and medicine is roughly comparable to that between science and technology79 \3- that is, it is impossible to reduce either therapeutics or technical activities to the simple application of basic science. In this sense, the application of vitamin D to vitamin-resistant rickets is quite typical. Further-more, in the case studied here, the therapeutic activity heralds a definite breaking away from the medicatrix naturae of conventional medicine dating back to ancient times, and it embodies a new concept of the organism and of disease: no longer can the diseased organism be thought of as merely having a perturbed equilibrium requiring restoration by means of a natural style of medicine. On the contrary, vitamin D resistance is an obstacle that indicates profound biological dysfunction, to be rectified only by means of an extremely aggressive and therefore dangerous therapy. The therapy thus serves to reveal the severity of the dysfunction, thereby leading inevitably to conceptual innovation. This sheds light on the theoretical innovations of which the therapeutic activity is capable.Therapeutic activity is also influenced by notions of health and illness, normal and pathological states, none of which may be determined entirely objectively. For example, the term healing as used by Albright in the case of resistant rickets that he described may be discussed in this light.Nosology, or the classification of diseases, depends largely on the description of clinical syndromes, which are themselves mainly based on subjective elements (discomfort, disability, or the extent of a patient's suffering). The advent of pathological anatomy at the beginning of the nineteenth century disrupted classification by introducing the concept of localized anatomical lesions81-and, hence, an element of material objectivity \3- into nosology. Radiological examination further complicated matters by enabling the equivalent of an autopsy on living matter. Lastly, biological examination complicated nosology by showing that biological anomalies may exist in human beings without necessarily leading to a pathological condition. Medical thinking can choose to combine all these elements to describe a disease, but can also separate them and retain only a few, or a single one, according to requirements - as did Albright.The notion of biological and pathological individuality is fundamental to the development of medical thinking. Whatever its theoretical origin, medical thinking has since ancient times incorporated the idea that each individual reacts differently to the same treatment and his own specific pathological tendencies. I mentioned earlier that in the history of vitamin D-resistant rickets the notion of rachitic tendency reflected this type of thinking. After 1937, this history progressed by successively separating new individual entities, affecting smaller and smaller groups of individuals in each case. In other words, the need to understand and to define individual illness more closely required the development of new concepts and the construction of new individual categories of disease linking these concepts to older clinical, radiological, and biochemical elements. (shrink)

Genetic predispositions often concern not only individual persons, but also other family members. Advances in the development of genetic tests lead to a growing number of genetic diagnoses in medical practice and to an increasing importance of genetic counseling. In the present article, a number of ethical foundations and preconditions for this issue are discussed. Four different models for the handling of genetic information are presented and analyzed including a discussion of practical implications. The different models’ ranges of content (...) reach from a strictly autonomous position over self-governed arrangements in the practice of genetic counseling up to the involvement of official bodies and committees. The different models show a number of elements which seem to be very useful for the handling of genetic data in families from an ethical perspective. In contrast, the limitations of the standard medical attempt regarding confidentiality and personal autonomy in the context of genetic information in the family are described. Finally, recommendations for further ethical research and the development of genetic counseling in families are given. (shrink)

Background Genomic research is challenging the tradition of informed consent. Genomic researchers in the USA, Canada and parts of Europe are encouraged to use informed consent to address the prospect of disclosing individual research results (IRRs) to study participants. In the USA, no national policy exists to direct this use of informed consent, and it is unclear how local institutional review boards (IRBs) may want researchers to respond. Objective and methods To explore publicly accessible IRB websites for guidance in this (...) area, using summative content analysis. Findings Three types of research results were addressed in 45 informed consent templates and instructions from 20 IRBs based at centres conducting genomic research: (1) IRRs in general, (2) incidental findings (IFs) and (3) a broad and unspecified category of ‘significant new findings’ (SNFs). IRRs were more frequently referenced than IFs or SNFs. Most documents stated that access to IRRs would not be an option for research participants. These non-disclosure statements were found to coexist in some documents with statements that SNFs would be disclosed to participants if related to their willingness to participate in research. The median readability of template language on IRRs, IFs and SNFs exceeded a ninth-grade level. Conclusion IRB guidance may downplay the possibility of IFs and contain conflicting messages on IRR non-disclosure and SNF disclosure. IRBs may need to clarify why separate IRR and SNF language should appear in the same consent document. The extent of these issues, nationally and internationally, needs to be determined. (shrink)

*The views represented in this article are those of the author and do not necessarily represent the views or policies of the American Medical Association.

Background The work of Research Ethics Boards (REBs), especially when involving genetics research and biobanks, has become more challenging with the growth of biotechnology and biomedical research. Some REBs have even rejected research projects where the use of a biobank with coded samples was an integral part of the study, the greatest fear being the lack of participant protection and uncontrolled use of biological samples or related genetic data. The risks of discrimination and stigmatization are a recurrent issue. In light (...) of the increasing interest in biomedical research and the resulting benefits to the health of participants, it is imperative that practical solutions be found to the problems associated with the management of biobanks: namely, protecting the integrity of the research participants, as well as guaranteeing the security and confidentiality of the participant's information. Methods We aimed to devise a practical and efficient model for the management of biobanks in biomedical research where a medical archivist plays the pivotal role as a data-protection officer. The model had to reduce the burden placed on REBs responsible for the evaluation of genetics projects and, at the same time, maximize the protection of research participants. Results The proposed model includes the following: 1) a means of protecting the information in biobanks, 2) offers ways to provide follow-up information requested about the participants, 3) protects the participant's confidentiality and 4) adequately deals with the ethical issues at stake in biobanking. Conclusion Until a governmental governance body is established in Quebec to guarantee the protection of research participants and establish harmonized guidelines for the management of biobanks in medical research, it is definitely up to REBs to find solutions that the present lack of guidelines poses. The model presented in this article offers a practical solution on a day-to-day basis for REBs, as well as researchers by promoting an archivist to a pivotal role in the process. It assures protection of all participants who altruistically donate their samples to generate and improve knowledge for better diagnosis and medical treatment. (shrink)

Le monstre, dans ses aspects extraordinaires, est pourtant une figure familière. Il est abordé dans ce petit traité à partir du questionnement médical. Ambroise Paré, la famille Saint-Hilaire, Etienne Wolff, tous ont participé à la constitution d'un statut épistémologique et rationnel du monstre. Mais ce traité n'oublie pas le fort pouvoir suggestif du monstre et son importance pour l'esthétique (littérature, peinture, cinéma). Il aborde alors les oeuvres de Méliès, Cronenberg, Artaud ou encore Francis Bacon. C'est ce qui fait du monstre (...) et de la monstruosité un thème philosophique fort. Il interroge nos existences en nous questionnant sur le rôle que l'on donne aux monstres ou encore aux merveilles comme celles que découvre Alice au-delà du miroir. Ce petit traité vient en complément d'un précédent ouvrage intitulé La Condition corporelle. Il reprend notre interrogation philosophique sur notre rapport au corps. Le corps monstrueux imposait l'existence de ce Petit traité de la monstruosité. (shrink)

Johannes Lydos quotes a passage from a lost military work on warfare against the Parthers in De magistratibus 3, 34. The author of this work, which dates from 63 AD, is said to be Κέλσος ὁ Ῥωμαῖος τακτικός, who has repeatedly been identified as Marius Celsus in several research studies. This article, however, depicts the encyclopedist and medical practitioner Aulus Cornelius Celsus as the author of this military writing. It first provides a retrospective of the research done. Secondly it (...) shows that two military writings are likely to exist in the works of Celsus and in a third step it puts forward a decisive argument against Marius Celsus. Finally, some further reflections on his interests and lifetime hint at Aulus Cornelius Celsus being the author. (shrink)

Wolfgang Huber recently reflected on current frontiers in medicine and exemplified the need for ethical boundaries especially in the case of the brain death definition, which appears to him to meet rather medical interests than the needs of human dignity. In contrast, this article describes the complex interdependence of medical innovation and ethical thinking in the development of the brain death definition in the USA. In this case, human dignity seems to be mediated with the individual life interest (...) at specifice intermediate Ievels, which are lying between the basic philosophical and the specific medical sphere. This may have helped to avoid disagreements caused by the various approaches of medical and ethical professionals and laymen. (shrink)

This paper concerns the double standard debate in the ethics of AI literature. This debate essentially revolves around the question of whether we should subject AI systems to different normative standards than humans. So far, the debate has centered around the desideratum of transparency. That is, the debate has focused on whether AI systems must be more transparent than humans in their decision-making processes in order for it to be morally permissible to use such systems. Some have argued that the (...) same standards of transparency should be applied across the board, for AI systems and humans alike. Others have argued that we should hold AI systems to higher standards than humans in terms of transparency. In this paper, we first point out that there are structurally similar double standard debates to be had about other desiderata besides transparency, such as predictive accuracy. Second, we argue that when we focus on predictive accuracy, there are at least two reasons for holding AI systems to a lower standard than humans. (shrink)

*The views expressed in this paper are those of the author and do not necessarily represent those of the American Medical Association.

Medical genetic interventions can be performed in two ways. First, genetic defects may be repaired (gene therapy). Secondly, a possible future individual (an embryo or a possible combination of gametes) may be preselected because of its favourable genetic make-up (by using genetic diagnostic methods and procedures from reproductive medicine so called Preimplantation Genetic Diagnosis). The first kind of intervention means that someone gets medical treatment in the normal sense, however, the second kind does not. Rather, in that case, (...) the potential patient is exchanged for another individual who is in no need of treatment. The paper explores to what extent arguments for and against these kinds of genetic intervention apply equally to all of them. For example, may the benefits that can be achieved through gene therapy be equally well achieved through genetic preselection? Are fears of a resurrection of eugenic practices through gene technology more warranted regarding therapeutic interventions than regarding preselective ones (or vice versa)? Since genetic preselection is an intervention at the germ-line level and is presently clinically applied: How is it possible to motivate that clinical application of germ-line gene therapy is not similarily permitted? (shrink)

La médecine personnalisée expérimente dans le cadre du cancer, ou thérapies ciblées, ou encore médecine prédictive, voire médecine de précision. toutes ces appellations sous-entendent un domaine qui s'ébauche tant au niveau de la recherche qu'à celui de la clinique. Ce domaine se constitue de pratiques, de normes qui s'élaborent et de règles qui établissent de véritables limites. Ce volume présente ce que les disciplines du droit, de la biologie, de la médecine et de la philosophie ont à dire conjointement sur (...) ce nouvel objet qui déjà intéresse au-delà du cancer toutes les maladies chroniques. Ce volume rassemble ainsi les réflexions de tous les pionniers de ce domaine sous la coordination de Michèle Jean-Stanton du Centre de Recherche de Droit Public (CRDP) de l'Université de Montréal et de Christian Hervé de l'Université Sorbonne Paris Cité. Leurs expressions, ainsi exposées à la suite d'un séminaire qu'ils ont tous suivi consciencieusement, affirment ainsi une certaine idée, une éthique même de ces nouvelles pratiques non encore totalement réglementées. (shrink)

The IOC and WADA have announced their ambition to develop control program in order to detect athletes' illegitimate use of genetic technology for enhancing performance. Although it is far from clear what such uses should be counted as illegitimate, as well as to what extent the idea of control programs for such things is a feasible idea, I will assume that such programs will concern so-called somatic genetic modifications that aims at altering the athlete's initial bodily biochemistry in a way (...) that may enhance performance without the presence of any medical reason for undertaking such modifications. This means that the envisioned control-program will have to make use of the method of genetic testing in order to detect the possible presence (or non-presence) of various genetic variants within the athlete. As a consequence of this, several ethical issues familiar within the field of genetic testing for health purposes are suddenly actualised within the area of doping control. These issues concern primarily how to handle and communicate the information about the athlete that is uncovered by such testing. However, due to the ways in which gene doping may be performed, in the case of atheletic control programs, issues of medical safety and the question of what hardships it is reasonable to require of athletes to endure also become paramount. As a consequence, one may ask whether or not sporting ethics will have to consider applying the rule of informed consent in connection to testing programs of the kind here discussed. (shrink)

In recent years a principle for responsible risk-taking called "The Precautionarity Principle" (PP) has been put forward in several policy documents regarding risk-management of technological and environmental issues. PP involves two claims: 1. An ethical claim according to which it is irresponsible to, for example, use new technologies, regdless of how large benefits these are known to bring, unless it has been proven that they will not give rise to unacceptable long term risks. 2. An administrative/political claim according to which (...) the burden of supplying the proof spoken of in claim 1 is to be laid on the supplier of the new technology. This paper deals only with claim 1, which is the real "precautionarity claim". PP has produced much enthusiasm in different political circles, where it is often held out as a landmark for a new thinking in risk-management. However, while claim 2 is clear enough, it is rather obscure how the precautionarity claim is to be understood. In particular, it is not clear to what extent (if any) this claim implies anything new for risk-analysis. This is so since the precautionarity claim does not say anything about what is to be counted as a proof, or what constitutes an unacceptable risk. The paper explores different conlicting interpretations of the precautionarity claim and demonstrates how the choice between these actualise hard ethical issues. In particular, the issue of how much damage we are allowed to cause in order to pursue safety and certainty is discussed. This issue is actualized when new technologies with known beneficiary effects cannot be proven to be "safe enough" according to some interpretations of the precautionarity claim unless investigated for a rather long period of time, during which the technology is not allowed to be used to produce the beneficiary effects it can produce. This problem is structurally similar to a well known issue in medical ethics regarding the rsponsibility of continuing a controlled clinical trial of a drug known to cure when this means that half of the patients suffers extra agony and earlier death because they get a placebo instead of the new drug.. (shrink)

Standard versions of the requirement of informed consent state that patients who are offered to enter a clinical trial of a medical procedure should be informed about risks and possible benefits of this procedure (compared to available alternatives) in order to facilitate a rational decision whether or not to participate. However, in many real cases where new medical procedures are to be clinically tested for the first time the information available for such communication to prospective patients is very (...) scarce, vague and/or uncertain. This phenomenon is illustrated by the clinical introduction of new procedures in reproductive medicine, such as preimplantation genetic diagnosis (PGD). Regarding such procedures, it has ben argued that, in such cases, the quality of the available information may be too low for the obtaining of informed consent to be possible, even if it is successfully communicated. Others, instead, holds that informed consent may always be obtained regardless of the quality of the available information. Unfortunately, the standard litterature on informed consent give no clue as to which of these interpretations is correct. This issue is explored by connecting the concept of informed consent to ethical ideas of respect for autonomy and ideas of rational decision making. It is argued, first, that low quality of available information regarding the risks and possible benefits of a medical procedure may indeed make the obtaining of informed consent from patients to undergo this procedure impossible even in theory. However, it is also argued that whether or not this is the case must be relativized to the actual needs and deires of individual patients. Thus, regarding one and the same procedure, informed consent may be impossible to obtain from some patients due to the low quality of the available information regarding this procedure, but still be possible to obtain from other patients. (shrink)