In response to the COVID-19 pandemic, large-scale research and pharmaceutical regulatory processes have proceeded at a dramatically increased pace with new and effective, evidence-based COVID-19 interventions rapidly making their way into the clinic. However, the swift generation of high-quality evidence and the efficient processing of regulatory authorisation have given rise to more specific and complex versions of well-known research ethics issues. In this paper, we identify three such issues by focusing on the authorisation of molnupiravir, a novel antiviral medicine aimed (...) at reducing the ability of SARS-CoV-2 to multiply in the body, for clinical use by the National Health Service in England and the concomitant testing of molnupiravir through the large-scale Platform Adaptive trial of Novel antiviRals for eArly treatMent of COVID-19 In the Community randomised control trial. By analysing the ways in which the authorisation and clinical use of molnupiravir complicate standard approaches to clinical equipoise, standard of care and participant consent in the PANORAMIC randomised control trial, we will explain some of ethical implications for clinical trials that aim to study the efficacy and safety of new COVID-19 and other therapeutics when conditional authorisation has already been granted and when such treatments have already been made available to patients by national health providers. (shrink)

In response to the COVID-19 pandemic, large-scale research and pharmaceutical regulatory processes have proceeded at a dramatically increased pace with new and effective, evidence-based COVID-19 interventions rapidly making their way into the clinic. However, the swift generation of high-quality evidence and the efficient processing of regulatory authorisation have given rise to more specific and complex versions of well-known research ethics issues. In this paper, we identify three such issues by focusing on the authorisation of Molnupiravir, a novel antiviral medicine aimed (...) at reducing the ability of SARS-CoV-2 to multiply in the body, for clinical use by the National Health Service in England and the concomitant testing of Molnupiravir through the large-scale PANORAMIC randomised control trial. By analysing the ways in which the authorisation and clinical use of Molnupiravir complicate standard approaches to clinical equipoise, standard of care, and participant consent in the PANORAMIC randomised control trial we will explain some of ethical implications for clinical trials that aim to study the efficacy and safety of new COVID-19 and other therapeutics when conditional authorisation has already been granted and when such treatments have already been made available to patients by national health providers. (shrink)

A central feature of experimental development economics is the use of randomized controlled trials (RCTs) to evaluate the effectiveness of prospective socioeconomic interventions. The use of RCTs in development economics raises a host of ethical issues which are just beginning to be explored. In this article, I address one ethical issue in particular: the routine use of the status quo as a control when designing and conducting a development RCT. Drawing on the literature on the principle of standard (...) class='Hi'>care in medical research ethics, as well as considerations of distributive justice in non-ideal circumstances, I argue that the practice of using the status quo as a control is ethically justifiable. However, I add an important qualification based on the natural duty of rescue to address the concern that my account is overly permissive. (shrink)

In this essay, we suggest practical ways to shift the framing of crisis standards of care toward disability justice. We elaborate on the vision statement provided in the 2010 Institute of Medicine (National Academy of Medicine) “Summary of Guidance for Establishing Crisis Standards of Care for Use in Disaster Situations,” which emphasizes fairness; equitable processes; community and provider engagement, education, and communication; and the rule of law. We argue that interpreting these elements through disability justice entails a commitment (...) to both distributive and recognitive justice. The disability rights movement's demand “Nothing about us, without us” requires substantive inclusion of disabled people in decision‐making related to their interests, including in crisis planning before, during, and after a pandemic like Covid‐19. (shrink)

That a standard of medical care must outline services that benefit the patient is relatively uncontroversial. However, one must determine how the practices outlined in a medical standard of care should benefit the patient. I will argue that practices outlined in a standard of medical care must not detract from the patient’s well-functioning and that clinicians can refuse to provide services that do. This paper, therefore, will advance the following two claims: (1) a (...) class='Hi'>standard of medical care must not cause dysfunction, and (2) if a physician is medically rational to not provide some service which fails to meet the above condition (i.e. fails to be a standard of medical care), then she may refuse to do so. I then apply my thesis to the prescription of puberty blockers to children with gender dysphoria. (shrink)

Though the duties of care owed toward innocents in war and in civil life are at the bottom univocally determined by the same ethical principles, Bazargan-Forward argues that those very principles will yield in these two contexts different “in-practice” duties. Furthermore, the duty of care we owe toward our own innocents is less stringent than the duty of care we owe toward foreign innocents in war. This is because risks associated with civil life but not war (a) (...) often increase the expected welfare of the individuals upon whom the risk is imposed, (b) are often imposed with consent, and (c) are often imposed reciprocally. The conclusion—that we have a pro tanto reason for adopting a more stringent standard of risk imposition toward foreign innocents in war—has implications for not only what standards of risk we should adopt in war, but also how we should weigh domestic versus foreign civilian lives. (shrink)

Are the standards of reasoning and rationality in divination, religious practice, and textual exegesis different from those in the sciences? Can there be different standards of reasoning and rationality at all? The intense “rationality debate” of the 1960s, 70s, and 80s focused on these questions and the related problems of relativism across cultures and systems of practice. Although philosophers were at the center of these debates at the time, they may appear to have abandoned the question in recent years. On (...) the contrary, I discuss recent developments in philosophy that approach the issue from a number of new directions, changing our understanding of reasoning and rationality. I argue that, in comparing the diviner to the scientist, focusing on reasoning is likely to be a red herring. Instead, I argue that a careful treatment of rationality, paying particular attention to its context-dependence, untangles longstanding confusions. Moreover, it points the way forward to investigating modest but interesting ways for there to be alternative standards of rationality. (shrink)

Background: Transgender health care is a subject of much debate among clinicians, political commentators, and policy-makers. While the World Professional Association of Transgender Health (WPATH) Standards of Care (SOC) establish clinical standards, these standards contain implied ethics but lack explicit focused discussion of ethical considerations in providing care. An ethics chapter in the SOC would enhance clinical guidelines. Aims: We aim to provide a valuable guide for healthcare professionals, and anyone interested in the ethical aspects of clinical (...) support for gender diverse and transgender people of all ages. Recognizing that the WPATH is a global association, we address broad challenges. We offer a reflection on general ethical principles, providing conceptual tools for healthcare providers, patients, and families to navigate the specific challenges they might encounter in transgender health care, in line with WPATH’s worldwide mission and scope. Method: This article employs a descriptive analysis, and our framework of reference is the four principles of biomedical ethics: respect for autonomy, beneficence, nonmaleficence, and justice. Results: The article presents a discussion on the four ethical principles as applied to transgender health care. We address issues such as respect for patient autonomy in decision-making, the role of beneficence and nonmaleficence in clinical interventions, and the importance of justice in equitable treatment and access to care. Some of the ethical concerns we address in this article pertain to the current sociopolitical climate, where there has been increasing legal interference, internationally, for transgender and nonbinary people, particularly youth, seeking medical care. Discussion: We highlight the interplay between ethical principles and clinical practice, underscoring the need for ethical guidance in addressing the diverse challenges faced by healthcare providers and patients in transgender health care. We advocate for continuous refinement of ethical thinking to ensure that transgender health care is not only medically effective but also ethically sound. (shrink)

Background Bronchial asthma is one of the most common chronic conditions among children. Despite the improvement in asthma treatment regimens, its prevalence and related morbidity are increasing, especially among underserved, minority children. There are barriers in the management of asthma, which may impact the quality of outcomes. The goal of this study is to explore these barriers. Methods A cross-sectional study was conducted on interview data collected through 2019 from mothers of children (aged 6 - 12 years) with asthma visiting, (...) for convenience, a public shopping mall. The interviewees were randomly selected, because they met the inclusion criteria. Participants were considered if the mother answered “yes” to the following questions: Has your child had physician-diagnosed asthma? Is your child currently taking asthma medications of asthma? Two community nurses conducted the interviews. Data was obtained using administrative questionnaires. Data were analyzed using SPSS version 21.0 (IBM Inc., Chicago, IL, USA). Descriptive statistics of percentage, mean, frequency and standard deviation were applied for categorical and continuous variables. Results Three hundred mothers participated in this study. Their average age was 36.8 years, 55% were housekeepers by profession, and 34% had obtained less than high school education. The majority of children (61%) were males, 45% had moderate asthma, and 42% had mild asthma. The most frequent types of barriers identified by parents were environmental factors (67.7%), followed by health care providers (63%), the health care system (48%), and patient or family characteristics (43%). Mothers were specifically concerned about the use, safety, and long-term complications of medications, the impact of exercise limitation on their child’s quality of life, and their own quality of life. Conclusion This study showed several barriers against asthma care in Saudi Arabia, which mainly related to environmental or personal characteristics. This highlights the need to enhance current policies within the health care system in Saudi Arabia to overcome these barriers. (shrink)

This article focuses on the ethical implications of so-called ‘collateral damage’. It develops a moral typology of collateral harm to innocents, which occurs as a side effect of military or quasi-military action. Distinguishing between accidental and incidental collateral damage, it introduces four categories of such damage: negligent, oblivious, knowing and reckless collateral damage. Objecting mainstream versions of the doctrine of double effect, the article argues that in order for any collateral damage to be morally permissible, violent agents must comply with (...) high standards of care. In order for incidental harm to be permissible, an agent must take pains to avoid such harm even at higher cost to him- or herself. It is argued that accidentally but negligently caused collateral damage may be just as difficult to excuse as incidental harm. Only if high precautionary standards of care are met, can unintended harm to innocents – incidental or accidental – be permissible. In practice, such a strong commitment to avoiding harm to civilians may well lead us to question more generally and rethink more radically how violent conflicts ought to be fought, how military violence ought to be used and whether there are better ways of achieving those aims that we think are legitimate than those we are currently using. (shrink)

The context of international health research involving human subjects, and this should appear obvious, is the human community. As such, basic questions of how human beings should be treated by other human beings, particularly in situations of unequal power – e.g., in the form of control, choice, or opportunity – lay at the foundations of related ethical discourse when ethics are discussed at all. I trace a narrative that follows upon a recent revision process of international guidelines for biomedical research (...) involving human subjects. I focus in particular upon the issue of a standard of care. In the second section, I draw upon philosophers John Rawls, Claudia Card, and Allen Buchanan to discuss concerns regarding the 'least advantaged members of society' in the context of global inequality. The paper includes reflections upon pedagogy in courses focused upon international health research involving human subjects. (shrink)

A large proportion of the total global burden of disease is caused by emergency medical conditions. Emergency care research is essential to improving emergency medicine but this research can raise some distinctive ethical challenges, especially with regard to (1) standard of care and risk–benefit assessment; (2) blurring of the roles of clinician and researcher; (3) enrolment of populations with intersecting vulnerabilities; (4) fair participant selection; (5) quality of consent; and (6) community engagement. Despite the importance of research (...) to improve emergency care in low-income and middle-income countries (LMICs) and the widely acknowledged ethical challenges, very little has been written on the ethics of emergency care research in LMICs. This paper examines the ethical and regulatory challenges to conducting emergency care research with human participants in LMICs. We outline key challenges, present potential solutions or frameworks for addressing these challenges, and identify gaps. Despite the ethical and regulatory challenges, conducting high-quality, ethical emergency care research in LMICs is possible and it is essential for global health. (shrink)

Background: Tuberculosis is among the major causes of illness and death worldwide especially in Asia. Smoking is associated with recurrent tuberculosis and its related mortality. Also, it could affect clinical manifestations, bacteriological conversion and outcome of treatment. This study aimed to evaluate the pattern of tobacco smoking, history of previous quit attempts and attitude towards quitting in tuberculosis patients. Materials and Methods: It was a cross-sectional study done amongst tuberculosis patients presented to DOTS corner of Rajshahi Medical College Hospital. 315 (...) patients entered the study as "First Come First Serve". Selfreported questionnaires were designed according to the standard questionnaires of smoking pattern. Results: Sixty one percent (61%) patients (n=192) were smoker before the diagnosis of tuberculosis. 51.1% were current smokers at the time of interview and were continuing smoking after the diagnosis of tuberculosis. Only 10.2% discontinued smoking after diagnosis. 68.2% smokes less than 10 cigarettes per day. 53.1% was between 31-50 age group. 21-30 is the commonest age group (62%) to start smoking is and 66.1% smoked less than 10 years before diagnosis. To reduce stress was the most common cause to continue smoking (48.9%). 71.9% smokers showed keen interest to stop smoking. Conclusion: Considering the prevalence of smoking in tuberculosis patients, evaluation of tobacco smoking status in such patients and motivating them to quit smoking could be considered as important steps in their treatment process. (shrink)

We discuss the role of prior authorization (PA) in supporting patient-centered care (PCC) by directing health system resources and thus the ability to better meet the needs of individual patients. We begin with an account of PCC as a standard that should be aimed for in patient care. In order to achieve widespread PCC, appropriate resource management is essential in a healthcare system. This brings us to PA, and we present an idealized view of PA in order (...) to argue how at its best, it can contribute to the provision of PCC. PA is a means of cost saving and as such it has mixed success. The example of the US demonstrates how implementation of PA has increased health inequalities whereas best practice has the potential to reduce them. In contrast, systems of universal coverage, like those in Europe, may use the cost savings of PA to better address individuals' care and PCC. The conclusion we offer therefore is an optimistic one, pointing towards areas of supportive overlap between PCC and PA where usually the incongruities are most evident. (shrink)

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

The COVID-19 (Coronavirus disease of 2019) pandemic has led to intense conversations about ventilator allocation and reallocation during a crisis standard of care. Multiple voices in the media and multiple state guidelines mention reallocation as a possibility. Drawing upon a range of neuroscientific, phenomenological, ethical, and sociopolitical considerations, the authors argue that taking away someone’s personal ventilator is a direct assault on their bodily and social integrity. They conclude that personal ventilators should not be part of reallocation pools (...) and that triage protocols should be immediately clarified to explicitly state that personal ventilators will be protected in all cases. (shrink)

The paper addresses the nature of duties grounded in human rights. Rather than being protections against harm, per se, I contend that human rights largely shield against risk impositions to protected interests. “Risk imposition” is a normative idea requiring explication, but understanding dutiful action in its terms enables human rights to provide prospective policy guidance, hold institutions accountable, operate in non-ideal circumstances, embody impartiality among persons, and define the moral status of agencies in international relations. Slightly differently, I indicate a (...) general understanding of dutiful action that permits human rights to see to the tasks of an institutional morality. (shrink)

The paper presents the outlines of an ontology of plans and guidelines, which is then used as the basis for a framework for implementing guideline-based systems for the management of workflow in health care organizations. The framework has a number of special features, above all in that it enables us to represent in formal terms assignments of work-items both to individuals and to teams and to tailor guideline to specific contexts of application in health care organizations. It is (...) designed also to enable implementations to do justice to the fact that the processes carried out in health care organizations may deviate in different ways from the norms set forth in corresponding guideline definitions. This means that implementations built in conformity with the framework will be marked by a type of flexibility that might make them more likely to be accepted by healthcare professionals than are standard guideline-based management systems. (shrink)

In "Frailty Triage: Is Rationing Intensive Medical Treatment on the Grounds of Frailty Ethical?," Wilkinson (2021) argues that the use of frailty scores in ICU triage does not necessarily involve discrimination on the basis of disability. In support of this argument, he claims, “it is not the disability per se that the score is measuring – rather it is the underlying physiological and physical vulnerability." While we appreciate the attention Wilkinson explicitly pays to disability in this piece, we find the (...) distinction between disability and underlying vulnerability untenable both theoretically and practically. In this peer commentary, we begin with a brief overview of research in philosophy of disability concerning the meaning of the concept itself. We argue that this research demonstrates that many forms of disability do not involve underlying vulnerabilities, and, furthermore, that Wilkinson equivocates between "disability" understood as a medical category vs. "disability" understood as a feature of lived experience. We reject Wilkinson’s distinction on these grounds and offer further considerations to avoid disability discrimination in emergency and crisis standards of care contexts. (shrink)

Starting from two observations regarding nursing ethics research in the past two decades, namely, the dominant influence of both the empirical methods and the principles approach, we present the cornerstones of a foundational argument-based nursing ethics framework. First, we briefly outline the general philosophical–ethical background from which we develop our framework. This is based on three aspects: lived experience, interpretative dialogue, and normative standard. Against this background, we identify and explore three key concepts—vulnerability, care, and dignity—that must be (...) observed in an ethical approach to nursing. Based on these concepts, we argue that the ethical essence of nursing is the provision of care in response to the vulnerability of a human being in order to maintain, protect, and promote his or her dignity as much as possible. (shrink)

The population ageing of Chinese society is deepening. The elderly care policy is a policy standard formulated by the government to protect the rights and interests of older people in the process of actively coping with the population ageing. It has crucial guiding significance for improving the elderly care services and carrying out pension practice. Since the reform and opening-up, China’s elderly care policy system has gone through three stages of initial construction, development, and transformation, showing (...) a development direction from aid to service, from one to multiple, from unique to general. In general, China has primarily formed a complete framework of the elderly care policy system, the rights, and interests of older people have been strongly guaranteed, the elderly care service industry has developed rapidly, and the quality of elderly care service has been effectively improved. However, in the process of policy development, there are still problems such as difficulty in implementing policies, low effectiveness, vague content, and fragmentation of policies. In the future, it is urgent to establish a complete, scientific, reasonable, and effective elderly care policy system. It should further expand the scope of benefits of old-age care policies, promote the coordinated development of the elderly care policies between urban and rural areas and among regions, strengthen the guiding and leading role of the government, and refine policies on personnel training, so as to form a powerful driving force for old-age care. (shrink)

Statistics play a critical role in biological and clinical research. However, most reports of scientific results in the published literature make it difficult for the reader to reproduce the statistical analyses performed in achieving those results because they provide inadequate documentation of the statistical tests and algorithms applied. The Ontology of Biological and Clinical Statistics (OBCS) is put forward here as a step towards solving this problem. Terms in OBCS, including ‘data collection’, ‘data transformation in statistics’, ‘data visualization’, ‘statistical data (...) analysis’, and ‘drawing a conclusion based on data’, cover the major types of statistical processes used in basic biological research and clinical outcome studies. OBCS is aligned with the Basic Formal Ontology (BFO) and extends the Ontology of Biomedical Investigations (OBI), an OBO (Open Biological and Biomedical Ontologies) Foundry ontology supported by over 20 research communities. We discuss two examples illustrating how the ontology is being applied. In the first (biological) use case, we describe how OBCS was applied to represent the high throughput microarray data analysis of immunological transcriptional profiles in human subjects vaccinated with an influenza vaccine. In the second (clinical outcomes) use case, we applied OBCS to represent the processing of electronic health care data to determine the associations between hospital staffing levels and patient mortality. Our case studies were designed to show how OBCS can be used for the consistent representation of statistical analysis pipelines under two different research paradigms. By representing statistics-related terms and their relations in a rigorous fashion, OBCS facilitates standard data analysis and integration, and supports reproducible biological and clinical research. (shrink)

The standard of care in the United States favors stabilizing any adult who arrives in an emergency department after a failed suicide attempt, even if he appears decisionally capacitated and refuses life-sustaining treatment. I challenge this ubiquitous practice. Emergency clinicians generally have a moral obligation to err on the side of stabilizing even suicide attempters who refuse such interventions. This obligation reflects the fact that it is typically infeasible to determine these patients’ level of decisional capacitation—among other relevant (...) information—in this unique setting. Nevertheless, I argue, stabilizing suicide attempters over their objection sometimes violates a basic yet insufficiently appreciated right of theirs—the right against bodily invasion. In such cases, it is at least prima facie wrong to stabilize a patient who wants to die even if they lack a contrary advance directive or medical order and suffer from no terminal physical illness. (shrink)

As health systems around the world turn towards highly distributed, specialized and cooperative structures to increase quality and safety of care as well as efficiency and efficacy of delivery processes, there is a growing need for supporting communication and collaboration of all parties involved with advanced ICT solutions. The Electronic Health Record (EHR) provides the information platform which is maturing towards the eHealth core application. To meet the requirements for sustainable, semantically interoperable, and trustworthy EHR solutions, different standards and (...) different national strategies have been established. The workshop summarizes the requirements for such advanced EHR systems and their underlying architecture, presents different strategies and solutions advocated by corresponding protagonists, discusses pros and cons as well as harmonization and migration strategies for those approaches. It particularly highlights a turn towards ontology-driven architectures. (shrink)

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

Since the original UN Universal Declaration of Human Rights1 laid out the general principles of human rights, there has been a split between what have been regarded as civil and political rights as opposed to economic, cultural and social rights. It was, in fact, the denial that both could be considered “rights” that prevented them from being included in the same covenant.2 Essentially, the argument for distinguishing the two concerns the nature of freedom. The civil rights to the freedoms of (...) speech, religion, assembly, association, and so on do not specify the content of the speech, the theology of the religion or the purpose of the assembly or association. 3 Freedom in such cases is necessarily value-neutral. In leaving the choice up to the individual, these rights purposefully abstract from the content of this choice. The case is quite different for economic, cultural and social rights. All of these necessarily express values with regard to the forms of our social organization. This is because they move beyond individual choices to consider the purposes or goals of our existence together. Thus, the rights to the cultivation of a cultural identity necessarily impact more than the individuals exercising them. As collective, they affect the society as a whole. The same holds for the UN sponsored rights of a person “to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing and medical care and necessary social services.”4 For a society to honor these rights involves specific choices with regard to its social content and collective organization. Such choices embody a particular value—in the UN’s words, that of the “social security” of the individual.5 Freedom, here, is freedom for specific social goals. Since these goals are collective, they.. (shrink)

Some bioethicists argue that conscientious objectors in health care should have to justify themselves, just as objectors in the military do. They should have to provide reasons that explain why they should be exempt from offering the services that they find offensive. There are two versions of this view in the literature, each giving different standards of justification. We show these views are each either too permissive (i.e. would result in problematic exemptions based on conscience) or too restrictive (i.e. (...) would produce problematic denials of exemption). We then develop a middle ground position that we believe better combines respect for the conscience of healthcare professionals with concern for the duties that they owe to patients. Our claim, in short, is that insofar as objectors should have to justify themselves, they should have to do it according to the standard that we defend rather than according to the standards that others have developed. (shrink)

The conventional wisdom about advance care planning holds that the normative force of my prior wishes is simply that they are mine. It is their connection to me that matters. This paper challenges conventional thinking. I propose that the normative force of prior wishes does not depend exclusively on personal identity. Instead, it sometimes depends on a special relationship that exists between a prior, capacitated person and a now incapacitated person. I consider what normative guidance governs persons who stand (...) in a special relationship, and contrast these with the standard model of respect for autonomy. My conclusion is that advance care planning for individuals who have lost decision-making capacity should incorporate the virtues of prudence and integrity, even when one and the same person ceases to exist, and respect for personal autonomy is no longer relevant. (shrink)

One recurring criticism of the best interests standard concerns its vagueness, and thus the inadequate guidance it offers to care providers. The lack of an agreed definition of ‘best interests’, together with the fact that several suggested considerations adopted in legislation or professional guidelines for doctors do not obviously apply across different groups of persons, result in decisions being made in murky waters. In response, bioethicists have attempted to specify the best interests standard, to reduce the indeterminacy (...) surrounding medical decisions. In this paper, we discuss the bioethicists’ response in relation to the state's possible role in clarifying the best interests standard. We identify and characterise two clarificatory strategies employed by bioethicists —elaborative and enumerative—and argue that the state should adopt the latter. Beyond the practical difficulties of the former strategy, a state adoption of it would inevitably be prejudicial in a pluralistic society. Given the gravity of best interests decisions, and the delicate task of respecting citizens with different understandings of best interests, only the enumerative strategy is viable. We argue that this does not commit the state to silence in providing guidance to and supporting healthcare providers, nor does it facilitate the abuse of the vulnerable. Finally, we address two methodological worries about adopting this approach at the state level. The adoption of the enumerative strategy is not defeatist in attitude, nor does it eventually collapse into (a form of) the elaborative strategy. (shrink)

Marine ecosystems are under increasing pressure from human activity, yet successful management relies on knowledge. The evidence-based policy (EBP) approach has been promoted on the grounds that it provides greater transparency and consistency by relying on ‘high quality’ information. However, EBP also creates epistemic responsibilities. Decision-making where limited or no empirical evidence exists, such as is often the case in marine systems, creates epistemic obligations for new information acquisition. We argue that philosophical approaches can inform the science-policy interface. Using marine (...) biosecurity examples, we specifically examine the epistemic challenges in the acquisition and acceptance of evidence to inform policy, discussing epistemic due care and biases in consideration of evidence. (shrink)

Joshua Mezrich is a practicing transplant surgeon who draws on his experiences, and those of his patients, to provide a "here's where we're at" moment in the story of transplant medicine. In so doing, he explains what it is like to practice while telling the stories of his patients, donors, and the pioneering surgeons who persisted in the face of failure to make what Mezrich does a work of healing. Written for a popular audience, When Death Becomes Life is perhaps (...) the most accessible work yet on the modern history of organ transplantation and what the current "standard of care" actually looks like. Indeed, it rounds out a "trinity" of quality books about the transplant experience, this one from the surgeon's... (shrink)

The foundations of research ethics are riven with fault lines emanating from a fear that if research is too closely connected to weighty social purposes an imperative to advance the common good through research will justify abrogating the rights and welfare of study participants. The result is an impoverished conception of the nature of research, an incomplete focus on actors who bear important moral responsibilities, and a system of ethics and oversight highly attuned to the dangers of research but largely (...) silent about threats of ineffective, inefficient, and inequitable medical practices and health systems. -/- In For the Common Good: Philosophical Foundations of Research Ethics, Alex John London defends a conception of the common good that grounds a moral imperative with two requirements. The first is to promote research that generates the information necessary to enable key social institutions to effectively, efficiently, and equitably safeguard the basic interests of individuals. The second is to ensure that research is organized as a voluntary scheme of social cooperation that respects its various contributors' moral claims to be treated as free and equal. Connecting research to the goals of a just social order grounds a framework for assessing and managing research risk that reconciles these requirements and justifies key oversight practices in non-paternalistic terms. Reconceiving research ethics as resolving coordination problems and providing credible assurance that these requirements are being met expands the issues and actors that fall within the purview of the field and provides the foundation for a more unified and coherent approach to domestic and international research. -/- This is an open access title available under the terms of a CC BY-NC-ND 4.0 license. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. (shrink)

An alliance of established experts on critical care, Front Line COVID-19 Critical Care Alliance (FLCCC), has published two protocols for treatment of COVID-19. The first one, methylprednisolone, ascorbic acid, thiamine, and heparin (MATH+), is intended for hospital and intensive care unit treatment of pulmonary phases of the disease. It is based on affordable, commonly available components: anti-inflammatory corticosteroids (methylprednisolone, "M"), high-dose vitamin C infusion (ascorbic acid, "A"), vitamin B1 (thiamine, "T"), anticoagulant heparin ("H"), antiparasitic agent ivermectin, and (...) supplemental components ("+") including melatonin, vitamin D, elemental zinc, and magnesium. -/- The MATH+ protocol has received scarce attention due to the World Health Organization (WHO) advising against the use of corticosteroids in the beginning of the pandemic. In addition, randomized controlled clinical trials were required as a condition for adoption of the protocol. As the hospital mortality rate of MATH+ treated patients was approximately a quarter of the rate of patients receiving a standard of care, the authors of the protocol considered performing such trials unethical. Other parties have later performed clinical trials with corticosteroids and anticoagulants, which has led to a more widespread adoption of these components. -/- In October 2020, ivermectin was upgraded from an optional component to an essential component of the protocol. According to the authors, ivermectin is considered the first agent effective for both prophylaxis (prevention) of COVID-19 and for treatment of all phases of COVID-19 including outpatient treatment of the early symptomatic phase. Therefore, at the end of October 2020, a separate ivermectin-based I-MASK+ protocol for prophylaxis and early outpatient treatment of COVID-19 was published. (shrink)

It is a matter of fact that Europe is facing more and more crucial challenges regarding health and social care due to the demographic change and the current economic context. The recent COVID-19 pandemic has stressed this situation even further, thus highlighting the need for taking action. Active and Assisted Living technologies come as a viable approach to help facing these challenges, thanks to the high potential they have in enabling remote care and support. Broadly speaking, AAL can (...) be referred to as the use of innovative and advanced Information and Communication Technologies to create supportive, inclusive and empowering applications and environments that enable older, impaired or frail people to live independently and stay active longer in society. AAL capitalizes on the growing pervasiveness and effectiveness of sensing and computing facilities to supply the persons in need with smart assistance, by responding to their necessities of autonomy, independence, comfort, security and safety. The application scenarios addressed by AAL are complex, due to the inherent heterogeneity of the end-user population, their living arrangements, and their physical conditions or impairment. Despite aiming at diverse goals, AAL systems should share some common characteristics. They are designed to provide support in daily life in an invisible, unobtrusive and user-friendly manner. Moreover, they are conceived to be intelligent, to be able to learn and adapt to the requirements and requests of the assisted people, and to synchronise with their specific needs. Nevertheless, to ensure the uptake of AAL in society, potential users must be willing to use AAL applications and to integrate them in their daily environments and lives. In this respect, video- and audio-based AAL applications have several advantages, in terms of unobtrusiveness and information richness. Indeed, cameras and microphones are far less obtrusive with respect to the hindrance other wearable sensors may cause to one’s activities. In addition, a single camera placed in a room can record most of the activities performed in the room, thus replacing many other non-visual sensors. Currently, video-based applications are effective in recognising and monitoring the activities, the movements, and the overall conditions of the assisted individuals as well as to assess their vital parameters. Similarly, audio sensors have the potential to become one of the most important modalities for interaction with AAL systems, as they can have a large range of sensing, do not require physical presence at a particular location and are physically intangible. Moreover, relevant information about individuals’ activities and health status can derive from processing audio signals. Nevertheless, as the other side of the coin, cameras and microphones are often perceived as the most intrusive technologies from the viewpoint of the privacy of the monitored individuals. This is due to the richness of the information these technologies convey and the intimate setting where they may be deployed. Solutions able to ensure privacy preservation by context and by design, as well as to ensure high legal and ethical standards are in high demand. After the review of the current state of play and the discussion in GoodBrother, we may claim that the first solutions in this direction are starting to appear in the literature. A multidisciplinary debate among experts and stakeholders is paving the way towards AAL ensuring ergonomics, usability, acceptance and privacy preservation. The DIANA, PAAL, and VisuAAL projects are examples of this fresh approach. This report provides the reader with a review of the most recent advances in audio- and video-based monitoring technologies for AAL. It has been drafted as a collective effort of WG3 to supply an introduction to AAL, its evolution over time and its main functional and technological underpinnings. In this respect, the report contributes to the field with the outline of a new generation of ethical-aware AAL technologies and a proposal for a novel comprehensive taxonomy of AAL systems and applications. Moreover, the report allows non-technical readers to gather an overview of the main components of an AAL system and how these function and interact with the end-users. The report illustrates the state of the art of the most successful AAL applications and functions based on audio and video data, namely lifelogging and self-monitoring, remote monitoring of vital signs, emotional state recognition, food intake monitoring, activity and behaviour recognition, activity and personal assistance, gesture recognition, fall detection and prevention, mobility assessment and frailty recognition, and cognitive and motor rehabilitation. For these application scenarios, the report illustrates the state of play in terms of scientific advances, available products and research project. The open challenges are also highlighted. The report ends with an overview of the challenges, the hindrances and the opportunities posed by the uptake in real world settings of AAL technologies. In this respect, the report illustrates the current procedural and technological approaches to cope with acceptability, usability and trust in the AAL technology, by surveying strategies and approaches to co-design, to privacy preservation in video and audio data, to transparency and explainability in data processing, and to data transmission and communication. User acceptance and ethical considerations are also debated. Finally, the potentials coming from the silver economy are overviewed. (shrink)

The standard argument for longtermism assumes that we should care as much about far future people as about our contemporaries. I challenge this assumption. I first consider existing interpretations of ‘temporal discounting’, and argue that such discounting seems either unwarranted or insufficient to block the argument. I then offer two alternative reasons to care less about far future people: caring as much about them as about our contemporaries would make our lives less authentic and less meaningful. If (...) I’m right, this undermines at least the strongest versions of longtermism. Plausibly, we should do much more for the far future than we’re currently doing. Still, we often ought to act for contemporaries’ sakes, even if longtermist actions would expectably do more good. (shrink)

Background: As part of a consistent effort to examine and provide integrative medical approaches to the therapeutic offering for psychophysical health, this study investigates the utilization of Olfactory Virtual Reality (OVR) in an inpatient psychiatry unit, more specifically in the Shepardson 3 Inpatient Psychiatry Unit at the University of Vermont Medical Center, in Burlington, VT, USA. Objectives: The purpose of this protocol is to explore the therapeutic value of olfactory virtual reality (OVR) in the above described population, and to collect (...) statistically significant data to determine the feasibility of potential future OVR studies. Method: Direct subject observation and monitoring in the context of Olfactory Virtual Reality (OVR) sessions and Qualitative data collection via the administration of subject surveys, subdivided in: a) Pre-OVR experience, b) Immediate post-OVR experience, and c) 1-to-3-hour post-OVR experience questionnaires. Results: The research yielded positive outcomes in all areas investigated, despite challenges related to the utilization of the device itself, issues in individual olfactory threshold, and COVID-19 restrictions and limitations. Conclusion: The outcome of this study indicates that the utilization of olfactory virtual reality technologies is a safe and effective integrative approach to target several aspects of psychological and physical health such as anxiety, stress, and pain, in combination with the psychotherapeutic and pharmacological standards of care in inpatient psychiatry. (shrink)

Dilip Ninan has raised a puzzle for centered world accounts of de re attitude reports extended to accommodate what he calls “counterfactual attitudes.” As a solution, Ninan introduces multiple centers to the standard centered world framework, resulting in a more robust semantics for de re attitude reports. However, while the so-called multi-centered world proposal solves Ninan’s counterfactual puzzle, this additional machinery is not without problems. In Section 1, I present the centered world account of attitude reports, followed by the (...) extension to counterfactual attitudes which Ninan targets with his puzzle. In Section 2, I pose the counterfactual puzzle and present Ninan’s multi-centered world solution, emphasizing similarities and differences between multi-centered and centered world accounts of attitude reports. In Section 3, I argue the counterfactual attitude wishing falls under the purview of the multi-centered proposal, but that the proposal generates false predictions for wish reports concerning unsatisfiable content. I canvass responses, ultimately concluding Ninan’s proposal requires substantial revisions. (shrink)

An elderly patient in a care home only wants human nurses to provide her care – not robots. If she selected her carers based on skin colour, it would be seen as racist and morally objectionable, but is choosing a human nurse instead of a robot also morally objectionable and speciesist? A plausible response is that it is not, because humans provide a better standard of care than robots do, making such a choice justifiable. In this (...) paper, I show why this response is incorrect, because robots can theoretically care as well as human nurses can. I differentiate between practical caring and emotional caring, and I argue that robots can match the standard of practical care given by human nurses, and they can simulate emotional care. There is growing evidence that people respond positively to robotic creatures and carebots, and AI software is apt to emotionally support patients in spite of the machine’s own lack of emotions. I make the case that the appearance of emotional care is sufficient, and need not be linked to emotional states within the robot. After all, human nurses undoubtedly ‘fake’ emotional care and compassion sometimes, yet their patients still feel adequately cared for. I show that it is a mistake to claim that ‘the human touch’ is in itself a contributor to a higher standard of care; ‘the robotic touch’ will suffice. Nevertheless, it is not speciesist to favour human nurses over carebots, because carebots do not suffer as the result of such a choice. (shrink)

The problem of probabilities of conditionals is one of the long-standing puzzles in philosophy of language. We defend and update Adams' solution to the puzzle: the probability of an epistemic conditional is not the probability of a proposition, but a probability under a supposition. -/- Close inspection of how a triviality result unfolds in a concrete scenario does not provide counterexamples to the view that probabilities of conditionals are conditional probabilities: instead, it supports the conclusion that probabilities of conditionals violate (...) standard probability theory. -/- This does not call into question probability theory per se; rather, it calls for a more careful understanding of its role: probability theory is a theory of probabilities of propositions; but as conditionals do not express propositions, their probabilities are not subject to the standard laws. -/- We argue that both conditional probabilities and probabilities of conditionals are best understood in terms of the dynamics of supposing, modeled as a restriction operation on a probability space. This version of the suppositionalist view allows us to connect Adams' Thesis to the widely held restrictor view of the semantics of conditionals. -/- We address two common objections to Adams' view: that the relevant probabilities are ‘probabilities only in name’, and that giving up conditional propositions puts us at a disadvantage when it comes to interpreting compounds. -/- Finally, we argue that some putative counterexamples to Adams' Thesis can be diagnosed as fallacies of probabilistic reasoning: they arise from applying to conditionals laws of standard probability theory which are invalid for them. (shrink)

Lavinia Marin draws from phenomenology to lay bare another aspect of the ubiquitous presence of social media. By taking the phenomenology of attention as a starting-point, she show that attention is – rather than only a scare resource as analysts departing from the perspective of the attention economy would have it – foundational for our moral relations to other beings. She argues that there is a distinctive form of other-oriented attention that enables us to perceive other beings as living beings (...) that are worthy of care. This mode of attention presupposes a form of affectivity and involves the recognition of the other as a moral being capable of forming judgments, as well as someone having certain vulnerabilities. Her analysis shows that by prioritizing homogenous interactions and standardization, social media platforms hinder us from engaging in this mode of attention, thereby undermining our capacity of recognizing to others as surprising, changing, and fallible beings. (shrink)

Discussions concerning whether there is a natural right to health care may occur in various forms, resulting in policy recommendations for how to implement any such right in a given society. But health care policies may be judged by international standards including the UN Universal Declaration of Human Rights. The rights enumerated in the UDHR are grounded in traditions of moral theory, a philosophical analysis of which is necessary in order to adjudicate the value of specific policies designed (...) to enshrine rights such as a right to health care. We begin with an overview of the drafting of the UDHR and highlight the primary influence of natural law theory in validating the rights contained therein. We then provide an explication of natural law theory by reference to the writings of Thomas Aquinas, as well as elucidate the complementary “capabilities approach” of Martha Nussbaum. We conclude that a right to health care ought to be guaranteed by the state. (shrink)

The field of bioethics is replete with applications of moral theories such as utilitarianism and Kantianism. For a given dilemma, even if it is not clear how one of these western philosophical principles of right (and wrong) action would resolve it, one can identify many of the considerations that each would conclude is relevant. The field is, in contrast, largely unaware of an African account of what all right (and wrong) actions have in common and of the sorts of factors (...) that for it are germane to developing a sound response to a given bioethical problem. My aim is to help rectify this deficiency by first spelling out a moral theory grounded in the mores of many sub-Saharan peoples, and then applying it to some major bioethical issues, namely, the point of medical treatment, free and informed consent, standards of care and animal experimentation. For each of these four issues, I compare and contrast the implications of the African moral theory with utilitarianism and Kantianism, my overall purposes being to highlight respects in which the African moral theory is distinct and to demonstrate that the field should take it at least as seriously as it does the Western theories. (shrink)

It is widely assumed that emotions are evaluative. Moreover, many authors suppose that emotions are important or valuable as evaluations. According to the currently dominant version of cognitivism, emotions are evaluative insofar as they make us aware of value properties of their intentional objects. In attributing to emotions an epistemic role, this view conceives of them as epistemically valuable. In this paper, I argue that proponents of this account mischaracterize the evaluative character of emotions and, a fortiori, their value. Moreover, (...) I propose an alternative view of emotional evaluation, according to which emotions are practically rather than epistemically important. As I argue, emotions are ways of acknowledging their intentional objects as (dis)valuable. As such, they do not apprehend values but make them count. I elaborate this idea by drawing an analogy with legal and political sanctions. The resulting view has it that emotions are practically important in that they affirm the cares and concerns which serve as standards of emotional evaluation. (shrink)

The Affordable Care Act (ACA) may be the most important health law statute in American history, yet much of the most prominent legal scholarship examining it has focused on the merits of the court challenges it has faced rather than delving into the details of its priority-setting provisions. In addition to providing an overview of the ACA’s provisions concerning priority setting and their developing interpretations, this Article attempts to defend three substantive propositions. First, I argue that the ACA is (...) neither uniformly hostile nor uniformly friendly to efforts to set priorities in ways that promote cost and quality. Second, I argue that the ACA does not take a single, unified approach to priority setting; rather, its guidance varies depending on the aspect of the health care system at issue (Patient Centered Outcomes Research Institute, Medicare, essential health benefits) and the factors being excluded from priority setting (age, disability, life expectancy). Third, I argue that cost-effectiveness can be achieved within the ACA's constraints, but that doing so will require adopting new approaches to cost-effectiveness and priority setting. By limiting the use of standard cost-effectiveness analysis, the ACA makes the need for workable rivals to cost-effectiveness analysis a pressing practical concern rather than a mere theoretical worry. (shrink)

Criminal courts make decisions that can remove the liberty and even life of those accused. Civil trials can cause the bankruptcy of companies employing thousands of people, asylum seekers being deported, or children being placed into state care. Selecting the right standards when deciding legal cases is of utmost importance in giving those affected a fair deal. This Element is an introduction to the philosophy of legal proof. It is organised around five questions. First, it introduces the standards of (...) proof and considers what justifies them. Second, it discusses whether we should use different standards in different cases. Third, it asks whether trials should end only in binary outcomes (e.g. guilty or not guilty) or rather use more fine-grained or precise verdicts. Fourth, it considers whether proof is simply about probability, concentrating on the famous 'Proof Paradox'. Finally, it examines who should be trusted with deciding trials, focusing on the jury system. (shrink)

In bioethics, the predominant categorization of various types of influence has been a tripartite classification of rational persuasion (meaning influence by reason and argument), coercion (meaning influence by irresistible threats—or on a few accounts, offers), and manipulation (meaning everything in between). The standard ethical analysis in bioethics has been that rational persuasion is always permissible, and coercion is almost always impermissible save a few cases such as imminent threat to self or others. However, many forms of influence fall into (...) the broad middle terrain—and this terrain is in desperate need of conceptual refining and ethical analysis in light of recent interest in using principles from behavioral science to influence health decisions and behaviors. This paper aims to address the neglected space between rational persuasion and coercion in bioethics. First, I argue for conceptual revisions that include removing the “manipulation” label and relabeling this space “nonargumentative]influence,” with two subtypes: “reason-bypassing” and “reason-countering.” Second, I argue that bioethicists have made the mistake of relying heavily on the conceptual categories themselves for normative work and instead should assess the ethical permissibility of a particular instance of influence by asking several key ethical questions, which I elucidate, that relate to (1) the impact of the form of influence on autonomy and (2) the relationship between the influencer and the influenced. Finally, I apply my analysis to two examples of nonargumentative influence in health care and health policy: (1) governmental agencies such as the Food and Drug Administration (FDA) trying to influence the public to be healthier using nonargumentative measures such as vivid images on cigarette packages to make more salient the negative effects of smoking, and (2) a physician framing a surgery in terms of survival rates instead of mortality rates to influence her patient to consent to the surgery. (shrink)

Beyond reasonable doubt, the influence of Western culture and civilizations has enervated traditional African family systems, and their functions as providers of social welfare. Hitherto, traditional African family and clan by extension served as the plausible medium by which Africans proffered solutions to those social, economic and other existential problems found within their communities. However, measuring and evaluating the successes of the various social welfare programs organized by the family and clan was a difficult task to achieve. It seems the (...) services rendered merely controlled the social problems but did not improve the standard of living of the victims. This paper seeks to critically analyse the traditional African family system and its role as a provider of social welfare and argues that it can complement the Western models towards holistic social integration. Thus this work adopts the theory of change as a tool for understanding how Western models of social welfare should be integrated with traditional African approaches to care for the ‘weak’ in the society. Advocating for a paradigm shift from the modern models of providing social welfare to the traditional African family and clan model is consequent upon the claim that the latter is more embracing in approach. (shrink)

Introduction: Universal health coverage (UHC) was introduced in Iran in 2014. The aim of this study was to evaluate the usage rate of health services by human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) patients after UHC implementation. Material and methods: In 2018, in a cross-sectional study, we evaluated the outpatients’ needs (within its previous month) and inpatients’ needs (within its previous 6 months) of HIV/AIDS patients in Isfahan province (the center of Iran). Concurrently, we estimated the essential health care (...) services that HIV/AIDS patients have to receive regularly, including vaccination for hepatitis B, measurement of CD4, tuberculosis (TB) assessments and TB treatment, anti-retroviral therapy, examination of viral load, treatment approach, and drug side effects counseling. Two checklists were used for assessing the utilization of health services and essential health cares for HIV/AIDS patients, validated by the Ministry of Health and Medical Education of Iran. Data were analyzed by χ2 test, Pearson’s correlation coefficient, and Spearman’s correlation test. Results: Two hundred and thirteen HIV/AIDS patients completed the questionnaires. The mean age of participants was 41.14 ± 9.23. The outpatient service utilization rate was 31.94% in the previous month and the rate of hospitalization was 126 per 1,000 HIV/AIDS patients in the previous 6 months. The majority of HIV/AIDS patients received essential health services more often than the national standard goals estimation. Conclusions: After UHC implementation, the utilization rate of outpatients and inpatients services in HIV/AIDS patients was more than similar indices in the general population. In addition, HIV/AIDS patients received essential health services adequately. (shrink)

This thesis examines philosophical controversies surrounding the evaluation of medical treatments, with a focus on the evidential roles of randomised trials and mechanisms in Evidence-Based Medicine. Current 'best practice' usually involves excluding non-randomised trial evidence from systematic reviews in cases where randomised trials are available for inclusion in the reviews. The first paper challenges this practice and evaluates whether adding of evidence from non-randomised trials might improve the quality and precision of some systematic reviews. The second paper compares the alleged (...) methodological benefits of randomised trials over observational studies for investigating treatment benefits. It suggests that claims about the superiority of well-conducted randomised controlled trials over well-conducted observational studies are justified, especially when results from the two methods are contradictory. The third paper argues that postulating the unpredictability paradox in systematic reviews when no detectable empirical differences can be found requires further justification. The fourth paper examines the problem of absence causation in the context of explaining causal mechanisms and argues that a recent solution is incomplete and requires further justification. Solving the problem by describing absences as causes of 'mechanism failure' fails to take into account the effects of absences that lead to vacillating levels of mechanism functionality. The fifth paper criticises literature that has emphasised functioning versus 'broken' or 'non-functioning' mechanisms emphasising that many diseases result from increased or decreased mechanism function, rather than complete loss of function. Mechanistic explanations must account for differences in the effectiveness of performed functions, yet current philosophical mechanistic explanations do not achieve this. The last paper argues that the standard of evidence embodied in the ICE theory of technological function is too permissive for evaluating whether the proposed functions of medical technologies have been adequately assessed and correctly ascribed. It argues that high-quality evidence from clinical studies is necessary to justify functional ascriptions to health care technologies. (shrink)

The paper presents the outlines of an ontology of plans and guidelines, which is then used as the basis for a framework for implementing guideline-based systems for the management of workflow in health care organizations. The framework has a number of special features, above all in that it enables us to represent in formal terms assignments of work-items both to individuals and to teams and to tailor guideline to specific contexts of application in health care organizations. It is (...) designed also to enable implementations to do justice to the fact that the processes carried out in health care organizations may deviate in different ways from the norms set forth in corresponding guideline definitions. This means that implementations built in conformity with the framework will be marked by a type of flexibility that might make them more likely to be accepted by healthcare professionals than are standard guideline-based management systems. (shrink)