Substituted judgment has increasingly become the accepted standard for rendering decisions for incapacitated adults in the USA. A broad exception exists with regard to patients with diminished capacity secondary to depressive disorders, as such patients’ previous wishes are generally not honoured when seeking to turn down life-preserving care or pursue aid-in-dying. The result is that physicians often force involuntary treatment on patients with poor medical prognoses and/or low quality of life as a result of their depressive symptoms when similarly situated (...) incapacitated patients without such depressive symptoms would have their previous wishes honoured via substituted judgment. This commentary argues for reconsidering this approach and for using a substituted judgment standard for a subset of EMP/LQL patients seeking death. (shrink)

In a recent response to our paper on developing a philosophical framework to guide the design and delivery of a just health service, Sarela raises several objections. We feel that although Sarela makes points which are worthy of discussion, his critique does not undermine either the need for, or the worth of, our proposed model. First, the law does not negate the need for ethics in determining just healthcare policy. Reliance on legal processes can drive inappropriate focus on ensuring policies (...) avoid judicial review, as opposed to ensuring they are truly just; the law affords protection against unjust policies but does not put a commitment to avoiding them at the heart of policy-making. We defend the need for Scanlonian supplementation by emphasising the practical value of adding a step based on reasonable rejection, particularly in ensuring that the views of vulnerable stakeholders are robustly considered. We discuss the similarities and differences between the work of Daniels and Sen in considering the relationship between health and opportunity, concluding that Sen’s capability approach is both valuable and compatible with our proposed model. Finally, the practical use of our model requires consideration of what constitutes a reasonable person. Our model is explicitly intended to help develop a healthcare system which is just to all its users. With this in mind, we suggest that those involved in decision-making should meet Scanlon’s definition of reasonable: they should be motivated to justify their actions to, and seek agreement with, others. (shrink)

On 7 April 2022 – coinciding with World Health Day – the British Medical Association launched its new report, Health and human rights in the new world order.1 Written during the global upheaval triggered by the COVID-19 pandemic, and published just weeks after the Russian invasion of Ukraine, the report responds to a range of emerging and intensifying threats to health-related human rights globally. As the report establishes, human rights in health and healthcare matter because human suffering, and its relief, (...) are fundamental moral issues. As relief of human suffering is the primary purpose of medicine, it follows that doctors and other health professionals are often active in times of human challenge and extremity. During conflict, humanitarian crises, and, as we have so recently seen, global public health emergencies, health professionals are essential to the response. But these crises – and the response to them – can put fundamental human rights and interests under pressure. The Russian invasion of Ukraine has seen sustained indiscriminate shelling of civilian infrastructure. Whether health facilities were directly targeted is moot – the indiscriminate nature of the assault means they will inevitably be hit. Not only is this a violation of the Geneva Conventions, it undermines fundamental human rights, not least of which the right to health. Destroying health infrastructure drives further suffering and delays post-conflict recovery. Public heath emergencies can rightly require draconian measures – social distancing, enforced isolation, location tracking, economic shutdown. Although we saw their necessity during the COVID-19 outbreak, concerns were raised about disproportionate restrictions on basic rights, including rights to privacy and liberty. Human Rights Watch drew attention to the way governments unlawfully exploited COVID-19 to crack down on fundamental rights.2 Although conflicts and public health emergencies are not new, the report also tracks a number of …. (shrink)

Recently, Petersen provided in this journal a critical discussion of individualisation arguments in the context of social egg freezing. This argument underlines the idea that it is morally problematic to use individual technological solutions to solve societal challenges that women face. So far, however, there is a lack of empirical data to contextualise his central normative claim that individualisation arguments are implausible. This article discusses an empirical study that supports a contextualised reading of the normative work of Petersen. Based on (...) a qualitative interview study, we found that most women could make sense of this argument but addressed other concerns that are overlooked in the premises of moral individualisation arguments, for instance, the influence of relationship formation on the demand of egg freezing. Furthermore, women did not experience social egg freezing as morally problematic. Nonetheless, the interviewees pointed to a need of more societal solutions and even actively advocated for efforts to increase accessibility such as a partial reimbursement and better quality of information. The implications of these findings for empirical bioethics are discussed. While more research is needed, we argue that, in order to better address individualisation arguments and related ethical concerns, we need to contextualise normative evaluations within women’s moral reasoning. (shrink)

According to G E Moore,1 we commit the naturalistic fallacy when we infer ‘x is good’ from non-evaluative premises involving x such as ‘ x is pleasant’ or ‘ x is desired’. On Moore’s view, the mistake is to think that we can reduce moral goodness to anything else or explain it in any other terms. We cannot analyse ‘good’, Moore thought, because goodness is simple, non-natural and sui generis. If Moore were alive today, and if he were to ask (...) contemporary bioethicists the right questions, he would probably find that many of them commit the naturalistic fallacy when they move from empirical premises to normative conclusions or when they articulate complex notions of the good. Pugh et al 2 might commit the naturalistic fallacy themselves when they conclude that people with natural immunity to COVID-19 should be exempt from vaccine mandates because such exemptions would achieve desired public health benefits. Moore would probably find me guilty of committing the naturalistic fallacy if I were to present my arguments against such exemptions. A reanimated Moore would find that the naturalistic fallacy pervades bioethics and public health. In contrast, as I shall argue, the un naturalistic fallacy is probably nowhere to be found. In this commentary, I explain what the so-called unnaturalistic fallacy really is and raise doubts about whether anyone really commits it. Decades after Moore published Principia Ethica, Bernard Williams observed that the naturalistic fallacy is unfortunately named since it is neither a fallacy nor an argumentative tendency unique to ethical naturalists.3 Ethical non-naturalists make the same mistake—if it is a mistake—when they move from, say, ‘x is commanded by the gods’ to ‘x is good’. Just as Moore’s ‘naturalistic fallacy’ misnames, Pugh et al ’s ‘unnaturalistic fallacy’ misleads. To be …. (shrink)

Evaluation of clinical ethical case consultations has been discussed as an important research task in recent decades. A rigid framework of evaluation is essential to improve quality of consultations and, thus, quality of patient care. Different approaches to evaluate those services appropriately and to determine adequate empirical endpoints have been proposed. A key challenge is to provide an answer to the question as to which empirical endpoints—and for what reasons—should be considered when evaluating the quality of a service. In this (...) paper, we argue for an approach that adopts the role of ethics consultants as its point of departure. In a first step, we describe empirical and ethical characteristics of evaluating clinical ethical case. We show that the mode of action and the explicit normative character of the interventions constitute two characteristics which pose challenges to the selection of appropriate quality criteria and require special attention. In a second step, we outline the way in which an analysis of the role of ethics consultants in the context of a clinical ethical case consultation services can account for the existing challenges by linking empirically measurable endpoints with normative theory. Finally, we discuss practical implications of our model for evaluation research. (shrink)

This paper considers the proposal to pay people to get vaccinated against the SARS-CoV-2 virus. The first section introduces arguments against the proposal, including less intrusive alternatives, unequal effects on populations and economic conditions that render payment more difficult to refuse. The second section considers arguments favouring payment, including arguments appealing to health equity, consistency, being worth the cost, respect for autonomy, good citizenship, the ends justifying the means and the threat of mutant strains. The third section spotlights long-term and (...) short-term best practices that can build trust and reduce ‘vaccine hesitancy’ better than payment. The paper concludes that people who, for a variety of reasons, are reluctant to vaccinate should be treated like adults, not children. Despite the urgency of getting shots into arms, we should set our sights on the long-term goals of strong relationships and healthy communities. (shrink)

I have two concerns about Pugh et al ’s case that vaccine requirements without a natural immunity exception are unjustified.1 First, the scientific question they suggest must be answered to justify the policy is in my view the wrong one, or at least not the only relevant one. Second, the authors set up a standard for public health regulation that will be often unattainable, risking paralysis of public health authorities. Pugh et al suggest two legitimate bases for vaccine mandates: ‘the (...) prevention of severe outcomes from COVID-19 and the reduction of viral transmission.’ Governments and employers have a legitimate interest in protecting the health of their citizens and workers, respectively. To maximally accomplish these goals, the relevant scientific question for whether people with prior infection should be subject to a vaccine mandate is: in persons who have been previously infected, does vaccination enhances protection against severe disease and/or infection and transmission? The relevant comparison, if one is trying to maximise protection in the population, is not vaccination vs prior infection, but vs prior infection alone. I am unaware of a systematic review of this question, but the answer in two recent studies appears to be that the combination is more protective.2,3 The comparison the authors propose, in contrast, seems to be one based on an unstated conception of fairness and adequacy: if vaccination alone provides some level of protection, and prior infection can’t be shown to provide an inferior level, then prior infection should be an acceptable alternative to vaccination to satisfy mandates. No argument is given to support the greater relevance of the comparison the authors emphasise. A second and independent concern is that the authors’ proposal …. (shrink)

While apparently helpful concepts such as ”best interests“ appear to have the virtue of simplicity, they are really place holders for the communication, time and listening that’s required to understand what truly matters to patients and others involved in healthcare. When we know what matters to a patient, we can have confidence that we have a “legitimate” view of what’s important to them. Two papers in this issue of the Journal of Medical Ethics explore different ways in which values can (...) be legitimised and applied consistently in healthcare. When a patient can no longer say what it is that matters to them and a significant decision needs to be made, the values that will inform what should happen next need to be legitimised in some way. Common ways of doing that include proxy decision makers or advanced directives. In this issue Jacob Appel calls for the ways in which “substituted judgments” are used for patients who have previously expressed a wish to die, to …. (shrink)

Many healthcare agencies are producing evidence-based guidance and policy that may determine the availability of particular healthcare products and procedures, effectively rationing aspects of healthcare. They claim legitimacy for their decisions through reference to evidence-based scientific method and the implementation of just decision-making procedures, often citing the criteria of ‘accountability for reasonableness’; publicity, relevance, challenge and revision, and regulation. Central to most decision methods are estimates of gains in quality-adjusted life-years, a measure that combines the length and quality of survival. (...) However, all agree that the QALY alone is not a sufficient measure of all relevant aspects of potential healthcare benefits, and a number of value assessment frameworks have been suggested. I argue that the practical implementation of these procedures has the potential to lead to a distorted assessment of value. Undue weight may be ascribed to certain attributes, particularly those that favour commercial or political interests, while other attributes that are highly valued by society, particularly those related to care processes, may be omitted or undervalued. This may be compounded by a lack of transparency to relevant stakeholders, resulting in an inability for them to participate in, or challenge, the decisions. The makes it likely that costly new technologies, for which inflated prices can be justified by the current value frameworks, are displacing aspects of healthcare that are highly valued by society. (shrink)

Judith Jarvis Thomson famously argued that abortion is permissible even if we accept that a fetus qualifies as a person and possesses a right to life. The current paper presents two arguments that undermine Thomson’s position. First, the paper sketches a contractarian argument that explores Thomson’s violinist thought experiment from behind a veil of ignorance, which suggests that if we had an equal likelihood of being an unwanted fetus and a pregnant woman, it would be rational for us to oppose (...) abortion. Second, the paper discusses the hypothetical self-aborting fetus, a thought experiment that reverses the dependence relationship between a woman and a fetus. It is argued that in this scenario, where fetuses have agency of their own, Thomson’s position would counterintuitively prohibit a woman from temporarily curtailing the freedom of her fetus even to save her own life. (shrink)

COVID-19 vaccine requirements have generated significant debate. Here, we argue that, on the evidence available, such policies should have recognised proof of natural immunity as a sufficient basis for exemption to vaccination requirements. We begin by distinguishing our argument from two implausible claims about natural immunity: natural immunity is superior to ‘artificial’ vaccine-induced immunity simply because it is ‘natural’ and it is better to acquire immunity through natural infection than via vaccination. We then briefly survey the evidence base for the (...) comparison between naturally acquired immunity and vaccine-induced immunity. While we clearly cannot settle the scientific debates on this point, we suggest that we lack clear and convincing scientific evidence that vaccine-induced immunity has a significantly higher protective effect than natural immunity. Since vaccine requirements represent a substantial infringement of individual liberty, as well as imposing other significant costs, they can only be justified if they are necessary for achieving a proportionate public health benefit. Without compelling evidence for the superiority of vaccine-induced immunity, it cannot be deemed necessary to require vaccination for those with natural immunity. Subjecting them to vaccine mandates is therefore not justified. We conclude by defending the standard of proof that this argument from necessity invokes, and address other pragmatic and practical considerations that may speak against natural immunity exemptions. There are no data in this work. (shrink)

In a recent JME paper, Matthew John Minehan applies John Rawls’ veil of ignorance against Judith Thomson’s famous violinist argument for the permissibility of abortion. Minehan asks readers to ‘imagine that one morning you are back to back in bed with another person. One of you is conscious and the other unconscious. You do not know which one you are’. Since from this position of ignorance, you have an equal chance of being the unconscious violinist and the conscious person attached (...) to him, it would be rational to oppose a right for detachment. Likewise, behind the veil of ignorance, it is rational to oppose abortions since you could be the fetus, Minehan claims. This paper provides a plausible reply to this argument. (shrink)

While COVID-19 has generated a massive burden of illness worldwide, healthcare workers have been disproportionately exposed to SARS-CoV-2 coronavirus infection. During the so-called ‘first wave’, infection rates among this population group have ranged between 10% and 20%, raising as high as one in every four COVID-19 patients in Spain at the peak of the crisis. Now that many countries are already dealing with new waves of COVID-19 cases, a potential competition between HCW and non-HCW patients for scarce resources can still (...) be a likely clinical scenario. In this paper, we address the question of whether HCW who become ill with COVID-19 should be prioritised in diagnostic, treatment or resource allocation protocols. We will evaluate some of the proposed arguments both in favour and against the prioritisation of HCW and also consider which clinical circumstances might warrant prioritising HCW and why could it be ethically appropriate to do so. We conclude that prioritising HCW’s access to protective equipment, diagnostic tests or even prophylactic or therapeutic drug regimes and vaccines might be ethically defensible. However, prioritising HCWs to receive intensive care unit beds or ventilators is a much more nuanced decision, in which arguments such as instrumental value or reciprocity might not be enough, and economic and systemic values will need to be considered. (shrink)

In their thoughtful, nuanced and interesting discussion, Jonathan Pugh, Julian Savulescu, Rebecca Brown and Dom Wilkinson argued that officials should recognise proof of prior infection as a valid exemption from vaccination requirements.1 This commentary agrees with parts of their analysis, but argues that the case for the exemption is less clear than the authors suggest, and the better approach is to allow officials flexibility: an exemption for natural immunity may be appropriate or may not. In part, the disagreements may stem (...) from different experiences in different societies. The authors are in the UK, and their experience may differ from the USA in multiple ways, three very glaring. First, the UK broadly used the AstraZeneca vaccine, which has higher risks than the mRNA vaccines, so our assessment of vaccine risks differs. Second, the UK has universal health insurance, so some of the access to testing issues that I raise concerns about may not apply there. And third, the risk of fraud or misrepresentation may be less in the UK—and other countries—than in the USA, where real concerns about, for example, fake vaccine cards have led to multiple arrests.2 Another issue is that information about COVID-19 changes fast—what was known when the authors wrote may no longer fit the current picture. In their article, the authors argue that it is ethically imperative that COVID-19 mandates exempt those with natural immunity. The authors argue that those who have become immune through infection are ‘potentially equivalent’ to those who were vaccinated, and refusing them an exemption is ethically unjustified—they call this the ‘unnaturalistic fallacy’. The authors convincingly conclude that existing data suggest that previous infection leads to durable immunity for at least several months and protects against reinfection. The …. (shrink)

Cox and Fritz state the central problem as the absence of a framework for healthcare policy decisions; but, they overlook the theoretical underpinnings of public law. In response, they propose a two-step procedure to guide fair decision-making. The first step relies on Thomas Scanlon’s ‘contractualism’ for stakeholders to consider whether, or not, they could reasonably reject policy proposals made by others; then in the second step, John Rawls’s principles of justice are applied to these proposals; a fair policy requires to (...) pass both steps. I argue that Cox and Fritz misinterpret Rawls. His theory has two stages: first, public reason is used to generate principles of justice; second, public reason is used to interpret and apply these principles. The second stage requires that proposals are based on the principles of justice from the first stage, and these proposals have to be acceptable to reasonable persons. Thus, Rawls’s theory does not need Scanlonian supplementation. Moreover, the application of Rawls’s theory in Cox and Fritz’s model is confusing. In any case, the problems with applying Rawlsian justice to healthcare can be located elsewhere. First, Rawls’s theory would treat healthcare simply as a ‘primary good’ or resource. Social justice ought to, instead, consider healthcare as an opportunity, in the manner conceived by Amartya Sen. Second, Rawlsian justice rests, ultimately, on the conception of a reasonable person; until and unless the characteristics of reasonable stakeholders are clarified, any model of health justice will remain hostage to the unreasonable. (shrink)

This is the account of an ongoing appeal initiated in 2009 by 725 doctors from 43 countries concerning medical complicity with torture in Israel. It has been underpinned by a voluminous and still accumulating evidence base from reputable international and regional human rights organisations, quoted below, and has spanned the terms of office of four World Medical Association presidencies and two UN special rapporteurs on torture. This campaign has been a litmus test of whether international medical codes regarding doctors and (...) torture actually matter, and are applied rigorously and even-handededly, particularly when compelling evidence incriminates a WMA member association. Our findings in the case of Israel suggest that this is not true, and that impunity largely operates. The WMA seems in partisan violation of its mandate to be the official international watchdog on the ethical behaviour of doctors. And as the IMA case demonstrates, by their inaction national medical associations or other regulatory bodies appear to function at base as buttresses and shields of the state. All data relevant to the study are included in the article. (shrink)

Health research ethics training programmes are being developed and implemented globally, often with a goal of increasing local capacity to assure ethical conduct in health-related research. Yet what it means for there to be sufficient HRE capacity is not well-defined, and there is currently no consensus on outcomes that HRE training programmes should collectively intend to achieve. Without defining the expected outcomes, meaningful evaluation of individual participants and programmes is challenging. In this article, we briefly describe the evolution of formal (...) education in HRE, articulate the need for a framework to define outcomes for HRE training programmes, and provide guidance for developing HRE competency frameworks that define outcomes suited to their contexts. We detail critical questions for developing HRE competency frameworks using a six-step process: define the purposes, intended uses and scope of the framework; describe the context in which practice occurs; gather data using a variety of methods to inform the competency framework; translate the data into competencies that can be used in educational programmes; report on the competency development process and results and evaluate and update the competency framework. We suggest that competency frameworks should be feasible to develop using this process, and such efforts promise to contribute to programmatic advancement. (shrink)

The rapid development and roll-out of COVID-19 vaccines has been a surprising success of the pandemic and has likely saved hundreds of thousands of lives. Although most people were eager to receive a vaccine, many jurisdictions introduced mandates to ensure rapid uptake in the population, especially among key workers including healthcare workers. In some instances, individuals who can prove they have recovered from COVID-19 have been exempt from vaccine mandates, but in other cases such exemptions have not been made. Pugh (...) et al argue that such exemptions for those already immune ought to be included in COVID-19 vaccine mandates.1 They review the evidence on infection-induced and vaccine-induced immunity and show that that there is not evidence that vaccines offer better protection against severe COVID-19 or of SARS-CoV-2 infection. They argue that to treat people differently based on the source of their COVID-19 immunity is wrongful discrimination, with this discrimination bringing harms in the form of unjust restriction of liberty and negative consequences such as lost employment. I agree with Pugh et al ’s view that, given the available evidence, infection-induced immunity to SARS-CoV-2 ought to be treated as equivalent to vaccine-induced immunity for the purposes of most COVID-19 vaccine mandates. However, their article highlights the need for clarity in the rationale for mandates. This clarity is necessary to be able to identify when exemptions are appropriate. It may be the case that in some instances infection-induced immunity ought not to be grounds for exemption. Pugh et al ’s argument also suggests that collection of data on infection-induced immunity may be a requirement for ethical vaccine mandates. To be confident in such exemptions, we need evidence that infection-induced immunity is comparable to vaccine-induced immunity in the …. (shrink)

Significant advancements towards a future of big data genomic medicine, associated with large-scale public dataset repositories, intensify dilemmas of genomic privacy. To resolve dilemmas adequately, we need to understand the relative force of the competing considerations that make them up. Attitudes towards genomic privacy are complex and not well understood; understanding is further complicated by the vague claim of ‘genetic exceptionalism’. In this paper, we distinguish between consequentialist and non-consequentialist privacy interests: while the former are concerned with harms secondary to (...) exposure, the latter represent the interest in a private sphere for its own sake, as an essential component of human dignity. Empirical studies of attitudes towards genomic privacy have almost never targeted specifically this important dignitary component of the privacy interest. In this paper we first articulate the question of a non-consequentialist genomic privacy interest, and then present results of an empirical study that probed people’s attitudes towards that interest. This was done via comparison to other non-consequentialist privacy interests, which are more tangible and can be more easily assessed. Our results indicate that the non-consequentialist genomic privacy interest is rather weak. This insight can assist in adjudicating dilemmas involving genomic privacy. Data are available in a public, open access repository. (shrink)

How shall we decide for others who cannot decide for themselves? And who—or what, in the case of artificial intelligence — should make the decision? The present issue of the journal tackles several interrelated topics, many of them having to do with surrogate decision making. For example, the feature article by Jardas et al 1 explores the potential use of artificial intelligence to predict incapacitated patients’ likely treatment preferences based on their sociodemographic characteristics, raising questions about the means by which (...) we come to decide for others. And a clinical ethics round table led by Wilkinson and Pillay2 examines the case of a premature baby on life support whose primary surrogate is herself incapacitated. Together, these examples force us to think more deeply about the meaning and significance of taken-for-granted concepts: respect for autonomy, substituted judgement, best interests. We’ll consider the baby first and then turn to AI. “Baby T” is a critically ill newborn delivered prematurely by emergency caesarean section. The mother had entered into a surrogacy arrangement with a same-sex male couple, the intended parents, who were to take over the baby’s care after birth—just as soon as a formal parental order could be obtained through the court. Until then, the birth mother, who had used her own eggs to conceive Baby T along with sperm from an unidentified donor, would have legal and ethical responsibility to decide about the baby’s care. Unfortunately, she too was in critical condition, having fallen unconscious prior to delivery due to a sudden brain haemorrhage. She remained unconscious, and thus incapacitated, during a crucial period in which time-sensitive decisions about Baby T’s care needed to be made, including whether to continue life support. Given the mother’s incapacity, who should …. (shrink)

The discussion around the use of the term ‘medical futility’ began in the late 1980s. The Polish Working Group on End-of-Life Ethics joined this discussion in 2008. They offered their own approach to the issues regarding medical futility based on the category of persistent therapy. According to the PWG, ‘persistent therapy is the use of medical procedures to maintain the life function of the terminally ill in a way that prolongs their dying, introducing excessive suffering or violating their dignity’. In (...) this paper I attempt to show that the term ‘persistent therapy’ is neither worse nor better than the term ‘medical futility’, but it captures different aspects and nuances. Additionally, the Polish social and religious background plays a significant role in shaping the category of persistent therapy. (shrink)

Defining quality of life is a difficult task as it is a subjective and personal experience. However, for the elderly, this definition is necessary for making complicated healthcare-related decisions. Commonly these decisions compare independence against safety or longevity against comfort. These choices are often not made in isolation, but with the help of a healthcare team. When the patient’s concept of quality of life is miscommunicated, there is a risk of harm to the patient whose best interests are not well (...) understood. In order to bridge this gap in understanding and unite seniors with their caretakers as a cohesive team, we need to establish a definition of quality of life. In this paper, my personal experiences with the elderly will be analysed along with five essays on the topic of ageing. These sources provide clear evidence that quality of life for seniors is majorly determined by the ability to preserve one’s lifelong identity. When making difficult decisions in geriatric healthcare, this greater understanding of the determinants of life quality will allow treatments to best serve the elderly. Defining quality of life allows healthcare providers to shift the focus from minimising disability toward maximising ability. I believe this shift would provide seniors with better health outcomes and properly enhance the quality of their years. Data sharing not applicable as no datasets generated and/or analysed for this study. (shrink)

The case states that a male same-sex couple entered into a surrogacy arrangement with an unrelated surrogate using donor sperm and the surrogate’s eggs. M is the legal mother pursuant to s33 of the Human Fertilisation and Embryology Act 2008. Though the facts tell us that there was no legally binding arrangement, this is in fact the position of the law: under s1A Surrogacy Arrangements Act, no surrogacy arrangements can ever be binding on the parties. It is not clear whether (...) the donor sperm is from one of the same-sex couple or not. If it was donor sperm and not from either intended father, this is not an arrangement that would be recognised in law, as one of the men must be genetically related to the child in order for them to obtain legal parenthood via a parental order, under s54 HFEA 2008. They could apply to adopt the child, although they may fall foul of adoption legislation1 if any money has moved between them and M and they do not fall within an exemption.2 In any event, an adoption cannot be achieved in time for them to obtain legal parenthood in a crisis situation. In the absence of a biological connection and the resulting legal parenthood, in order to obtain parental responsibility for the child to allow them to make decisions about Baby T’s care, the men would need to apply for leave to apply for a child arrangements order pursuant to s10 Children Act 1989. However, in the …. (shrink)

The patient preference predictor is a proposed computer-based algorithm that would predict the treatment preferences of decisionally incapacitated patients. Incorporation of a PPP into the decision-making process has the potential to improve implementation of the substituted judgement standard by providing more accurate predictions of patients’ treatment preferences than reliance on surrogates alone. Yet, critics argue that methods for making treatment decisions for incapacitated patients should be judged on a number of factors beyond simply providing them with the treatments they would (...) have chosen for themselves. These factors include the extent to which the decision-making process recognises patients’ freedom to choose and relies on evidence the patient themselves would take into account when making treatment decisions. These critics conclude that use of a PPP should be rejected on the grounds that it is inconsistent with these factors, especially as they relate to proper respect for patient autonomy. In this paper, we review and evaluate these criticisms. We argue that they do not provide reason to reject use of a PPP, thus supporting efforts to develop a full-scale PPP and to evaluate it in practice. There are no data in this work. (shrink)

The neonatal nurse forges a unique partnership with parents of a critically ill infant who are often, unexpectedly, exposed to the bewildering and complex environment that is neonatal intensive care, helping navigate them through this unchartered territory. Our role is multifaceted, with the primary focus of providing care in the best interests of our patients.1 This is realised through the provision of high-quality evidence-based care, advocating for the needs of the baby and family, and when required acting as a linchpin (...) bridging communication channels between medical and nursing teams, other allied health professionals, and the family.1 2 Ordinarily, the birth of an extremely preterm infant is a distressing, life-changing event for parents; this is further complicated by a number of additional factors in this complex scenario3. (shrink)

Animal ethics committees typically focus on the welfare of animals used in experiments, neglecting the potential welfare impact of that animal use on the animal laboratory personnel. Some of this work, particularly the killing of animals, can impose significant psychological burdens that can diminish the well-being of laboratory animal personnel, as well as their capacity to care for animals. We propose that AECs, which regulate animal research in part on the basis of reducing harm, can and ought to require that (...) these harms to researchers are reduced as well. The paper starts by presenting evidence of these burdens and their harm, giving some examples showing how they may be mitigated. We then argue that AECs are well placed to account for these harms to personnel and ought to use their power to reduce their occurrence. We conclude by responding to four potential objections: that this problem should be addressed through health and safety administration, not research ethics administration; that the proposal is unjustifiably paternalistic; that these harms to laboratory animal personnel ought to occur, given their treatment of animals; and that mitigating them may lead to worse treatment of research animals. All data relevant to the study are included in the article. (shrink)

New models of data governance for health data are a focus of growing interest in an era of challenge to the social licence. In this article, we reflect on what the data trust model, which is founded on principles of participatory governance, can learn from experiences of involving and engagement of members of the public and participants in the governance of large-scale biobanks. We distinguish between upstream and ongoing governance models, showing how they require careful design and operation if they (...) are to deliver on aspirations for deliberation and participation. Drawing on this learning, we identify a set of considerations important to future design for data trusts as they seek to ensure just, proportionate and fair governance. These considerations relate to the timing of involvement of participants, patterns of inclusion and exclusion, and responsiveness to stakeholder involvement and engagement. We emphasise that the evolution of governance models for data should be matched by a commitment to evaluation. There are no data in this work. (shrink)

When a patient lacks sufficient capacity to make a certain treatment decision, whether because of deficits in their ability to make a judgement that reflects their values or to make a decision that reflects their judgement or both, the decision must be made by a surrogate. Often the best way to respect the patient’s autonomy, in such cases, is for the surrogate to make a ‘substituted’ judgement on behalf of the patient, which is the decision that best reflects the patient’s (...) values and identity-infused beliefs as they were when the patient last possessed capacity. It is by now well-known that there is troubling evidence that surrogates do only slightly better than chance at making accurate substituted judgements. The use of a patient preference predictor, an algorithm that predicts patient preferences based on characteristics like the patient’s age, gender, socioeconomic status and education level, could help. Rid and Wendler have done important work making a moral case for using the PPP.1 If it were shown to enhance accuracy, it is not at all obvious what objections there could be to its use. Yet several subtle criticisms of the PPP have emerged in the literature. In their feature article, Jardas, Wasserman and Wendler select six of the most prominent objections to the PPP in the literature and defend the PPP against them.2 Along the way they make significant contributions to broader issues concerning the proper uses of statistical evidence and limits on the kinds of preferences there can be reasons of autonomy to respect. Since I found the authors’ answers to the final two objections—that the PPP relies on naked statistical evidence and that it uses non-endorsed reasons—to be especially interesting and provocative, I will examine those answers and raise a few questions about …. (shrink)

Physicians anecdotally report inquiring about incarcerated patients’ crimes and their length of sentence, which has potential implications for the quality of care these patients receive. However, there is minimal research on how a physician’s awareness of their patient’s crimes/length of sentence impacts physician behaviours and attitudes. We performed regression modelling on a 27-question survey to analyse physician attitudes and behaviours towards incarcerated patients. We found that, although most physicians did not usually try to learn of their patients’ crimes, they often (...) became aware of them. We observed associations between awareness of a patient’s crime and poor physician disposition towards their patients and between physicians’ poor dispositions and lower reported quality of care. These associations suggest that awareness of a patient’s crime may reduce quality of care by negatively impacting physicians’ dispositions towards their patients. Future quantitative and qualitative studies, for example, involving physician interviews and direct patient outcome assessments, are needed to confirm these findings and further uncover and address hurdles incarcerated patients face in seeking medical care. Data are available upon request. (shrink)

As clinicians, this case1 raises both personal and professional challenges. A key issue is who carries legal parental responsibility for the difficult decisions that may be required around life-sustaining care in baby T. Medicolegally, we understand that the surrogate mother holds legal parental responsibility for baby T until this can be transferred to the intended parents.2 But this process can take many months to complete, after the birth of baby. As M is now critically ill and unable to engage in (...) any discussion around the care of her baby, who becomes the legal guardian of the baby, for complex decision making that involves either reorientation of care away from intensive care with the inevitable consequence of death in this extremely premature baby, or continuing this life-sustaining treatment with a high likelihood for major neonatal morbidity and longer term disability? Does it pass onto one of the IPs as the genetic father, or does this responsibility fall on the neonatal consultant managing the baby in intensive care? And if an antenatal surrogacy agreement had existed, is it legally binding for inclusion of the IPs perspectives in the decision-making, especially if our medical decision making turns out to be at discord with the beliefs and wishes of the IPs for baby T? Box 1 ### Current surrogacy proceedings in the UK.2 6–8 The Law Commission UK5 is currently reviewing the decision on whether legal parenthood to intended parents can be effected immediately at the time of birth of the baby. Parental orders. (shrink)

The UK government has put lateral flow antigen tests at the forefront of its strategy to scale-up testing in the coronavirus pandemic. However, evidence from a pilot trial using an LFAT to identify asymptomatic infections in the community suggested that the test missed over half of the positive cases in the tested population. This raises the question of whether it can be ethical to use an inaccurate test to guide public health measures. We begin by explicating different dimensions of test (...) accuracy, and why they matter morally, before highlighting key data from the Liverpool pilot. We argue that the poor sensitivity of the LFAT in this pilot trial suggests that there are important limitations to what we can expect these tests to achieve. A test with low sensitivity will provide false-negative results, and in doing so generate the risk of false assurance and its attendant moral costs. However, we also suggest that the deployment of an insensitive but specific test could identify many asymptomatic carriers of the virus who are currently being missed under existing arrangements. Having outlined ways in which the costs of false reassurance could potentially be mitigated, we conclude that the use of an insensitive LFAT in mass testing may be ethical if it is used predominantly to identify positive cases, it is a cost-effective method of achieving that goal and if other public health tools can effectively prevent widespread false reassurance. The data cited in this study are available in the cited publically available documents. (shrink)

The US healthcare industry emits an estimated 479 million tonnes of carbon dioxide each year; nearly 8% of the country’s total emissions. When assessed by sector, hospital care, clinical services, medical structures, and pharmaceuticals are the top emitters. For 15 years, research has been dedicated to the medical structures and equipment that contribute to carbon emissions. More recently, hospital care and clinical services have been examined. However, the carbon of pharmaceuticals is understudied. This article will focus on the carbon emissions (...) of pharmaceuticals since they are consistently calculated to be among the top contributors to healthcare carbon and assess the factors that contribute to pharmaceutical carbon emissions. Specifically, overprescription, pharmaceutical waste, antibiotic resistance, routine prescriptions, non-adherence, drug dependency, lifestyle prescriptions, and drugs given due to a lack of preventive healthcare will be identified. Prescribing practices have environmental ramifications. Carbon reduction, when focused on pharmaceuticals, can lead to cleaner, more sustainable healthcare. All data relevant to the study are included in the article. (shrink)

The question of how to treat an incapacitated patient is vexed, both normatively and practically—normatively, because it is not obvious what the relevant objectives are; practically, because even once the relevant objectives are set, it is often difficult to determine which treatment option is best given those objectives. But despite these complications, here is one consideration that is clearly relevant: what a patient prefers. And so any device that could reliably identify a patient’s preferences would be a promising tool for (...) guiding the treatment of incapacitated patients. The patient preference predictor is just such a tool—an algorithm that takes as inputs a patient’s sociodemographic characteristics, and outputs a reliable prediction about that patient’s treatment preferences.1 But some have worried that the use of such a tool would violate or fail to appropriately respect patients’ autonomy. There are, I think, two ways to understand this kind of criticism. First, globally—as a worry that any systematic implementation of the PPP would be problematic on the grounds that it would result in significant or pervasive autonomy violations. Second, locally—as a worry that in some important range of cases, certain uses of the PPP would be problematic on autonomy grounds. Jardas et al, as I read them, address global autonomy-based criticisms, arguing—convincingly, in my view—that there’s no reason to suspect the autonomy concerns raised by the PPP would be so significant and pervasive as to render any implementation of it generally problematic.1 But even with the global criticisms rebuffed, there remains work to be done. Any ethically acceptable implementation of the PPP must be sensitive to the more local autonomy-based criticisms, with restrictions and safeguards in place to ensure respect for autonomy in the kinds of cases in which the use of the PPP might otherwise threaten …. (shrink)

The patient preference predictor is a computer-based algorithm devised to predict the medical treatment that decisionally incapacitated patients would have preferred. The target paper argues against various criticisms to the effect that the use of a PPP is inconsistent with proper respect for patient autonomy.1 In this commentary, I aim to add some clarifications to the complex relationship between autonomy and the PPP. First, I highlight one way in which the decision of a surrogate designated by the patient realises respect (...) for patient autonomy in a way that PPP cannot realise by introducing the idea of shared agency. Second, I show how the attempt to predict someone’s hypothetical choice can be disrespectful to her autonomy. Following the treatment decision of a surrogate designated by the patient counts as a way of respecting the patient’s own autonomy. Designating someone as one’s surrogate is a case of entrusting her with the task of making important life decisions on one’s behalf. To entrust someone with a certain matter is to assign her the responsibility for that matter based on the trust that she will take a good care of it. When a patient entrusts a surrogate decision-maker, what is the matter that she is trusted to take a good care of? In many contexts, the surrogate is r egarded as an epistemic proxy, one who is likely to know the patient’s preferences the best. It is often thought that the point of practising surrogate decision making is to respect the patient’s autonomy by following what the patient most likely would have preferred. Using a PPP in the decision-making process has the same goal of making a more accurate prediction of the patient’s treatment preference. However, at least in some cases, designating the patient’s intimates or ones she loves and cares …. (shrink)

In the case that triggered this round-table discussion there are three separate factors that contribute to moral uncertainty.1 First, the infant, baby T, is extremely premature with suspected brain injury and potentially poor prognosis. Second, the gestational mother is critically unwell herself and her outlook is guarded. Third, as linked commentaries make clear, the legal status of the intended parents is complex and ambiguous.2 3 Any of these factors on their own would be enough to generate ethical complexity and distress (...) in the neonatal intensive care unit. The combination of the three is likely to be highly stressful for all concerned.4 Commentaries on the case emphasise the complex legal questions and the potential need to involve the court. One resource that is not mentioned is the potential value of clinical ethics input in such a case. This is complementary to the need for legal advice. Its aim would be to help think through the specifically ethical, rather than legal questions. There are several things that I would aim to clarify if chairing a clinical ethics discussion on the case. First, it may be useful to draw on the concept of the …. (shrink)

Care of the critically ill newborn includes support for the birth mother/parents with regular updates around the clinical condition of the baby, and involvement in discussions around complex decision-making issues. Discussions around continuation or discontinuation of life-sustaining are challenging even in the most straightforward of cases, but what happens when the birth mother is critically unwell? Such cases can lead to uncertainty around who should assume the parental role for these difficult discussions. In this round table discussion, we explore the (...) ethical, moral and legal uncertainties raised by coincident severe maternal and neonatal illness in the context of surrogacy. There are no data in this work. (shrink)

Unregulated patient treatments and approved clinical trials have been conducted with haematopoietic stem cells and mesenchymal stem cells for children with autism spectrum disorder. While the former direct-to-consumer practice is usually considered rogue and should be legally constrained, regulated clinical trials could also be ethically questionable. Here, we outline principal objections against these trials as they are currently conducted. Notably, these often lack a clear rationale for how transplanted cells may confer a therapeutic benefit in ASD, and thus, have ill-defined (...) therapeutic outcomes. We posit that ambiguous and unsubstantiated descriptions of outcome from such clinical trials may nonetheless appeal to the lay public as being based on authentic scientific findings. These may further fuel caregivers of patients with ASD to pursue unregulated direct-to-consumer treatments, thus exposing them to unnecessary risks. There is, therefore, a moral obligation on the part of those regulating and conducting clinical trials of stem cell-based therapeutic for ASD minors to incorporate clear therapeutic targets, scientific rigour and reporting accuracy in their work. Any further stem cell-based trials for ASD unsupported by significant preclinical advances and particularly sound scientific hypothesis and aims would be ethically indefensible. No data are available. (shrink)

BackgroundFinancial compensation of research participants has been standard practice for centuries, however, there is an ongoing debate among researchers and ethicists regarding the ethical nature of this practice. While these debates develop ethical arguments and theories, they fail to incorporate input from those most affected by financial compensation: potential research participants.MethodsTo identify attitudes surrounding clinical research, participants of a long-standing cohort completed a one-time interview. Open-ended questions stimulated a participant-driven discussion surrounding medical research. Following a grounded theory methodology, 58 semistructured (...) interview transcripts were coded, focusing on attitudes surrounding financial compensation of research participants.ResultsOf the interviews coded, the majority of participants identified as Black/African American and were women. Five major themes emerged. In support of financial compensation, participants felt that study participants should be compensated for time, effort and risk. However, participants were concerned that compensation may differentially impact low-income populations and entice them to hide potentially harmful side effects. Participants also mentioned that financial compensation may invalidate study results if participants knowingly provide false information to subvert inclusion/exclusion criteria.ConclusionThe emergence of both positive and negative themes reiterates the complicated issue of providing financial compensation for study participation. While compensation as a motivator for research participation raises ethical concerns, participants discussed weighing the benefits with the risks in order to make an informed decision. To avoid paternalistic behaviours, research staff must allow potential research participants to review the available information and make the decision that best reflects their wishes. (shrink)

With new technologies come new ethical challenges. Often, we can apply previously established principles, even though it may take some time to fully understand the detail of the new technology - or the questions that arise from it. The International Commission on Radiological Protection, for example, was founded in 1928 and has based its advice on balancing the radiation exposure associated with X-rays and CT scans with the diagnostic benefits of the new investigations. They have regularly updated their advice as (...) evidence has accumulated and technologies have changed,1 and have been able to extrapolate from well-established ethical principles. Other new technologies lend themselves less well to off-the-peg ethical solutions. In several articles in this edition the ethical challenges associated with the use of artificial intelligence in medicine are addressed. Although multiple ethical codes and guidelines have been written on the use and development of AI, Hagendorf noted that many of them reiterated a ‘ deontologically oriented, action-restricting ethic based on universal abidance of principles and rules’. 2 Applying pre-existing ethical frameworks to artificial intelligence is problematic for several reasons. In particular, AI has two characteristics which are very different from the current clinical practice on which traditional medical ethics are based: 1. The so called ‘black box’ of deep learning, whereby a deep neural network is trained to iteratively adapt to make …. (shrink)

Background and aimsFew Polish hospitals have Hospital Ethics Committee and the services are not always adequate. In this situation, the role of HECs, in providing, among others, ethical advice on the discontinuation of persistent therapies, may be taken over by other entities. The aim of our research was to investigate, how often and on what issues hospital chaplains are asked for ethical advice in reaching difficult medical decisions.MethodsA survey of 100 Roman Catholic chaplains was conducted, that is, at least 10% (...) of all chaplains currently working in Polish hospitals.ResultsOf the participants, 29% confirmed receiving requests for advice in making a morally difficult medical decision. Receiving this type of request was not conditional on the place of their service, duration of their pastoral mission or HEC membership. The largest group of chaplains encounter questions concerning the ethical dilemmas associated with discontinuing persistent therapy. Patients and their families most often raise issues related to the methods of birth control, and the medical staff raise the issue of termination of pregnancy—as reported by 9% and 15% of chaplains, respectively. Most of the chaplains asked for help experience a deficit of specialist knowledge in the area of medicine or ethics.ConclusionsIn order to improve the quality of ethical consultations in Polish hospitals, in addition to further development of HECs, it is postulated to develop a system for bioethical education of chaplains. (shrink)

In their paper ‘Responsibility, second opinions and peer-disagreement: ethical and epistemological challenges of using AI in clinical diagnostic contexts’, Kempt and Nagel discuss the use of medical AI systems and the resulting need for second opinions by human physicians, when physicians and AI disagree, which they call the rule of disagreement.1 The authors defend RoD based on three premises: First, they argue that in cases of disagreement in medical practice, there is an increased burden of proof for the physician in (...) charge, to defend why the opposing view is adopted or overridden. This burden for justification can be understood as an increased responsibility. In contrast, such burden does allegedly not arise, when physicians agree in their judgement. Second, in those medical contexts where humans collaborate with humans such justification can be provided, since human experts can discuss the evidence and reasons that have led them to their judgement, through which the sources of disagreement can be found and a justified decision can be made by the physician in charge. Third, unlike human-to-human collaboration, such communicative exchange is not possible with an AI system. Due to AI’s opacity, the physician in charge has no means of illuminating why the AI disagrees. Conclusively, the authors propose RoD as a solution. RoD suggests that a second human expert should be consulted for advise in cases of human–AI disagreement. Once AI systems become more widespread in clinical practice, it can be expected that such type of disagreement occurs more frequently. AI, after all, is being implemented, because it promises, among others, higher accuracy, which implies that some abnormalities will be detected that the physician would have missed.2 Hence, it is laudable to discuss the moral implications of …. (shrink)

BackgroundThe quality of ethics consults is notoriously difficult to measure. Survey-based assessments cannot capture nuances of consultations. To address this gap, we conducted interviews with health professionals who requested ethics consults during the initial phase of the COVID-19 pandemic.MethodHealthcare professionals requesting ethics consultation between March 2020 and May 2020 at a tertiary academic medical centre were eligible to participate. We asked participants to comment on the consults they called and thematically analysed responses to identify features associated with optimal quality consultations.ResultsOf (...) 14 healthcare providers, 8 were women and professions were as follows: 11 medical doctors, 1 social worker, 1 physician assistant and 1 nurse practitioner. Two aspects of quality emerged: satisfaction and value. Themes within the domain of satisfaction included: responsiveness of the ethics consultant, willingness to consult, institutional role of the ethics service and identifying areas for improvement. When describing value, respondents spoke of the intrapersonal and interpersonal worth of consultation.ConclusionParticipants were generally satisfied with ethics consultation services, similar to opinions of those found in pre-COVID-19 survey studies. Our qualitative approach allowed for a richer exploration of the value of ethics consultation during the pandemic and has implications for ethics consultation services more broadly. Ethics consultation—emphasising both the process and outcome—created valuable moral spaces, promoting thoughtful and ethical responses to dilemmas in patient care. Future assessments should incorporate patient and family/surrogate perspectives and explore the domain of education as an additional quality measure. (shrink)

In this paper, we first classify different types of second opinions and evaluate the ethical and epistemological implications of providing those in a clinical context. Second, we discuss the issue of how artificial intelligent could replace the human cognitive labour of providing such second opinion and find that several AI reach the levels of accuracy and efficiency needed to clarify their use an urgent ethical issue. Third, we outline the normative conditions of how AI may be used as second opinion (...) in clinical processes, weighing the benefits of its efficiency against concerns of responsibility attribution. Fourth, we provide a ‘rule of disagreement’ that fulfils these conditions while retaining some of the benefits of expanding the use of AI-based decision support systems in clinical contexts. This is because the rule of disagreement proposes to use AI as much as possible, but retain the ability to use human second opinions to resolve disagreements between AI and physician-in-charge. Fifth, we discuss some counterarguments. (shrink)

In their article, ‘Responsibility, Second Opinions, and Peer-Disagreement—Ethical and Epistemological Challenges of Using AI in Clinical Diagnostic Contexts,’ Kempt and Nagel argue for a ‘rule of disagreement’ for the integration of diagnostic AI in healthcare contexts. The type of AI in question is a ‘decision support system’, the purpose of which is to augment human judgement and decision-making in the clinical context by automating or supplementing parts of the cognitive labor. Under the authors’ proposal, artificial decision support systems which produce (...) automated diagnoses should serve chiefly as confirmatory tools; so long as the physician and AI agree, the matter is settled, and the physician’s initial judgement is considered epistemically justified. If, however, the AI-DSS and physician disagree, then a second physician’s opinion is called on to resolve the dispute. While the cognitive labour of the decision is shared between the physicians and AI, the final decision remains at the discretion of the first physician, and with it the moral and legal culpability. The putative benefits of this approach are twofold: healthcare administration can improve diagnostic performance by introducing AI-DSS without the unintended byproduct of a responsibility gap, and assuming the physician and AI disagree less than the general rate of requested second opinions, and the AI’s diagnostic accuracy supersedes or at least …. (shrink)

In ‘The Complex Case of Ellie Anderson’, Joona Rasanen and Anna Smajdor raise several ethical questions about the case. One question asks, but does not answer, whether Ellie faced discrimination for being transgender when her mother was not allowed access to Ellie’s sperm following her death. In raising the question, the authors imply anti-trans bias may have influenced this determination. However, this inference is not supported by current ethical and legal guidance for posthumous use of gametes, with which Ellie’s case (...) is consistent. We consider the authors’ responses to their other ethical queries, and how their suggestions for what options might have been available to Ellie and her family are instructive for addressing attempts in the USA and UK to restrict minors’ access to gender-affirming medical treatment, including puberty-blocking therapy. (shrink)

The UK Government’s Code of Conduct for data-driven health and care technologies, specifically artificial intelligence -driven technologies, comprises 10 principles that outline a gold-standard of ethical conduct for AI developers and implementers within the National Health Service. Considering the importance of trust in medicine, in this essay I aim to evaluate the conceptualisation of trust within this piece of ethical governance. I examine the Code of Conduct, specifically Principle 7, and extract two positions: a principle of rationally justified trust that (...) posits trust should be made on sound epistemological bases and a principle of value-based trust that views trust in an all-things-considered manner. I argue rationally justified trust is largely infeasible in trusting AI due to AI’s complexity and inexplicability. Contrarily, I show how value-based trust is more feasible as it is intuitively used by individuals. Furthermore, it better complies with Principle 1. I therefore conclude this essay by suggesting the Code of Conduct to hold the principle of value-based trust more explicitly. (shrink)

Physicians and other healthcare professionals are increasingly finding ways to use artificial intelligent decision support systems in their work. IBM Watson Health, for example, is a commercially available technology that is providing AI-DDS services in genomics, oncology, healthcare management and more.1 AI’s ability to scan massive amounts of data, detect patterns, and derive solutions from data is vastly more superior than that of humans. AI technology is undeniably integral to the future of healthcare and public health, and thoughtful consideration of (...) the legal, ethical and moral issues surrounding this technology is a must. The authors of the article, Responsibility, Second Opinions, and Peer-Disagreement—Ethical and Epistemological Challenges of Using AI in Clinical Diagnostic Contexts, provide an informed discussion of how AI-DSS may be used, both practically and ethically, to assist healthcare professionals in cooperative diagnostic processes2. The authors propose a process, whereby AI-DSS would provide a physician a second opinion, and when there is a mismatch between opinions, another physician would provide a third opinion. This approach maintains a ‘physician-in-charge’ perspective, and suggests that decision-making must ultimately be made by a person. This approach is also consistent with the ‘physician in-the-loop’ concept, such that even when increasingly autonomous AI-DSSs are put to use, physicians will still be providing checks and overseeing clinical decisions. The authors conceptualise AI as a replacement of human cognitive labour. That is, AI is used to supplant a human professional in particular functions …. (shrink)

Prioritarianism pertains to the generic idea that it matters more to benefit people, the worse off they are, and while prioritarianism is not uncontroversial, it is considered a generally plausible and widely shared distributive principle often applied to healthcare prioritisation. In this paper, I identify social justice prioritarianism, severity prioritarianism and age-weighted prioritarianism as three different interpretations of the general prioritarian idea and discuss them in light of the effect of pandemic consequences on healthcare priority setting. On this analysis, the (...) paper arrives at the following three conclusions: that we have strong prioritarian reasons for special concern about the vulnerable and socially disadvantaged in reference to pandemic effects, that severity of illness is an important factor in identifying the worse off in priority setting but that this must not over-ride the special priority to the socially disadvantaged and that the maximisation rationale of the age-weighted view runs against the core prioritarian idea, and the age-weighted prioritarianism is thus unfitting as a prioritarian response to the COVID-19 case. (shrink)

In a recent article, ‘Why lockdown of the elderly is not ageist and why levelling down equality is wrong’, Savulescu and Cameron argue that a selective lockdown of older people is not ageist because it would treat people unequally based on morally relevant differences. This response argues that a selective lockdown of older people living in long-term care homes would be unjust because it would allow the expansive liberties of the general public to undermine the basic liberties of older people, (...) and because it would discriminate on the basis of extrinsic disadvantages. (shrink)

In parts of the world, discussion regarding COVID-19 has shifted towards endemicity, and questions of living with, rather than directly battling, the virus. As a result, ethical questions are being refocussed. The imperative is beginning to shift towards what we can learn from the pandemic, and how we can better prepare for future global outbreaks. Among the questions that need to be addressed is what Covid-29 has taught us about how research can be conducted ethically during major global public health (...) emergencies. It is widely accepted that research has an essential role to play in improving the effectiveness of health interventions in major public health crises.1 Even before COVID-19, a special series published in The Lancet highlighted the critical role of research in humanitarian crises, and lamented the paucity of good data on the effectiveness of health interventions in these particularly demanding contexts.2 The impact of expedited vaccine research on the mortality, morbidity and global disruption of the COVID-19 pandemic would be difficult to exaggerate. But it is clear that one important driver of vaccine hesitancy was public concern about the speed with which research into the vaccines was undertaken and hence the reliability of the data concerning their safety.3 Although for understandable reasons, the focus of attention on ethical research during the COVID-19 pandemic has been on vaccines and anti-virals, research in public health emergencies involves a wide range of activities designed to generate evidence, including social science research – which can be particularly critical in understanding barriers to vaccine uptake for example – along with epidemiological studies and health systems research. One widely acknowledged area of ethical tension concerning research in public health emergencies is between the need for rapid ethical review, and the strong moral requirement …. (shrink)

Postmortem sperm donation implies the acceptance of a very low sperm quality threshold. This threshold has two important consequences: recipients will have to submit to burdensome and expensive in vitro fertilisation/intracytoplasmic sperm injection, and many more living donors will be accepted, thus making postmortem donors largely superfluous. Given these strong arguments against the use of postmortem collected sperm, a good alternative to enlarge the donor pool would be men who stored sperm for self-use and no longer have the intention to (...) use it. (shrink)

Ellie Anderson had always known that she wanted to have children. Her mother, Louise, was aware of this wish. Ellie was designated male at birth, but according to news sources, identified as a girl from the age of three. She was hoping to undergo gender reassignment surgery at 18, but died unexpectedly at only 16, leaving Louise grappling not only with the grief of losing her daughter, but with a complex legal problem. Ellie had had her sperm frozen before starting (...) hormone treatment, specifically so that she would retain the chance of becoming a parent after her gender reassignment. Ellie had considered what might happen to the sperm if she died and was adamant that her children should be brought into the world. She made her mother promise to ensure that this would happen. But according to UK law, Ellie’s mother has no legal right to retain her sperm, or to use it to fulfil Ellie’s wishes. In this paper, we raise several key ethical questions on this case, namely: does a refusal to bring Ellie’s children into the world wrong her posthumously? Is Ellie’s mother morally entitled to use her daughter’s sperm as Ellie wished? Should the fact that Ellie was a minor at the time of her death or the fact that she was transgendered undermine her wish to have children? Can Ellie become a parent posthumously? We consider how these complex ethical questions could be approached. (shrink)

This paper explores ethical issues raised by whole slide image-based computational pathology. After briefly giving examples drawn from some recent literature of advances in this field, we consider some ethical problems it might be thought to pose. These arise from the tension between artificial intelligence research—with its hunger for more and more data—and the default preference in data ethics and data protection law for the minimisation of personal data collection and processing; the fact that computational pathology lends itself to kinds (...) of data fusion that go against data ethics norms and some norms of biobanking; the fact that AI methods are esoteric and produce results that are sometimes unexplainable and the fact that computational pathology is particularly dependent on scanning technology manufacturers with interests of their own in profit-making from data collection. We shall suggest that most of these issues are resolvable. (shrink)

Being a medically qualified patient can be an unpleasant experience for a person who is used to making decisions. For the most part, this applies to the vast majority of doctors and other healthcare professionals. Becoming passive and surrendering the decision-making process to others is alien to the medical culture we were taught. However, when as a hospitalised medically qualified patient, one sees fellow patients in difficulty, or deteriorating clinically, unnoticed by medical staff, the question of whether it is ethical (...) to intervene arises. I report my views on this as a largely passive, but still actively thinking patient. (shrink)

Lack of vaccine confidence can contribute to drops in vaccination coverage and subsequent outbreaks of diseases like measles and polio. Low trust in vaccines is attributed to a combination of factors, including lack of understanding, vaccine scares, flawed policies, social media and mistrust of vaccine manufacturers, scientists and decision-makers. The COVID-19 crisis has laid bare societies’ vulnerability to new pathogens and the critical role of vaccines in containing this and future pandemics. It has also put science at the forefront of (...) the response, with several governments relying on academics to help shape policy and communicate with the public. Against this backdrop, protecting public trust in scientists and scientific output is arguably more important than ever. Yet, conflicts of interest in biomedical research remain ubiquitous and harmful, and measures to curb them have had limited success. There is also evidence of bias in industry-sponsored vaccine studies and academics are voicing concerns about the risks of working in a CoI prevalent research area. Here, we set out to challenge established thinking with regard to vaccine confidence, by shifting the gaze from a deficit in public understanding towards probity in research relationships and suggesting an alternative and perhaps complementary strategy for addressing vaccine mistrust. We argue that a concerted effort needs to be made to revisit the norms that undergird contemporary vaccine research, coupled with a willingness of all stakeholders to reimagine those relationships with an emphasis on demonstrating trustworthiness and probity. (shrink)

Artificial intelligence systems are increasingly being used in healthcare, thanks to the high level of performance that these systems have proven to deliver. So far, clinical applications have focused on diagnosis and on prediction of outcomes. It is less clear in what way AI can or should support complex clinical decisions that crucially depend on patient preferences. In this paper, we focus on the ethical questions arising from the design, development and deployment of AI systems to support decision-making around cardiopulmonary (...) resuscitation and the determination of a patient’s Do Not Attempt to Resuscitate status. The COVID-19 pandemic has made us keenly aware of the difficulties physicians encounter when they have to act quickly in stressful situations without knowing what their patient would have wanted. We discuss the results of an interview study conducted with healthcare professionals in a university hospital aimed at understanding the status quo of resuscitation decision processes while exploring a potential role for AI systems in decision-making around code status. Our data suggest that current practices are fraught with challenges such as insufficient knowledge regarding patient preferences, time pressure and personal bias guiding care considerations and there is considerable openness among clinicians to consider the use of AI-based decision support. We suggest a model for how AI can contribute to improve decision-making around resuscitation and propose a set of ethically relevant preconditions—conceptual, methodological and procedural—that need to be considered in further development and implementation efforts. (shrink)

In this article, we want to reply to the recent article by Buturovic, to be able to correct some statements and allegations about this combined procedure. Organ donation after euthanasia is an extremely difficult procedure from an ethical point of view. On the one hand, we see a suffering patient who wants to die but who also wants to make an altruistic effort to donate his organs. On the other hand, we visualise a patient in need of an organ but (...) who is wary of the fact that someone else needs to die in order to potentially receive a transplant organ. Healthcare professionals seem to walk a tightrope when balancing between the interests of the patients at these two extremes: while facilitating the dying patient’s last wish on the one hand and abiding by all regulations regarding donation and transplantation on the other. Yet, these physicians, nurses and transplant coordinators do their utmost best to keep a strict line between euthanasia and organ donation, to avoid any external pressure on the patient, and to respect his autonomy. They really make an utmost attempt to make the process bearable for the donating patient. However, undeniably the patient who is about to undergo organ donation after euthanasia is nevertheless confronted with dozens of feelings and thoughts. However, this does not imply that procedural safeguards are failing to disentangle organ donation from euthanasia. (shrink)

As donor trust legitimises research, trust is vital for research in the fields of biomedicine, genetics, translational medicine and personalised medicine. For parts of the donor community, the consent signature is a sign of trust in research. Many consent processes in biomedical research ask donors to provide their data for an unspecified future use, which introduces uncertainty of the unknown. This uncertainty can jeopardise donor trust or demand blind trust. But which donor wants to trust blindly? To reduce this uncertainty, (...) we explore first, which future-proof actors donors could trust when signing a consent form. Second, we discuss the question Can we know if donor trust expires? and what prevents donor trust from expiring. Finally, we present possible measures that can help to nurture trust in the far future. In this article, we draw on our previous research on trust in biomedical research, on trust in the broader healthcare system and Niklas Luhmann’s and Anthony Giddens’ trust theories. Our findings suggest that, in the far future, researchers will need to consider donor autonomy, as well as societal norms and values of the time period in which the data were donated. They will need to find mechanisms where possible to publicly announce the use of old data sets. However, foremost researchers will need to treat the data respectfully. It remains vital that professionals and the society continue to elaborate on the norms and values that shape the common understanding of what is morally right and wrong when researching data. (shrink)

In Gustavsson et al,1 we discussed the ethical issues that arise when identifying the relevant population for disease-modifying drugs targeting Alzheimer disease. More specifically, we focused on novel immunotherapies aimed at amyloid β and tau, two relevant biomarkers. The commentaries to our paper2 3 acknowledge our conclusion: screening for AD involve ethical costs that cannot be justified unless a drug with clinically relevant effect becomes available. Since Aduhelm is the only immunotherapy targeting AD currently approved by the Food and Drug (...) Administration, we use that as a …. (shrink)

Duty of candour legislation was introduced in Scotland in 2018. However, literature and experience of duty of candour when applied to infection control incidents/outbreaks is scarce. We describe clinician and parental perspectives with regard to duty of candour and communication during a significant infection control incident in a haemato-oncology ward of a children’s hospital. Based on the learning from this incident, we make recommendations for duty of candour and communication to patients and families during future infection control incidents. These include (...) the need to consider a crisis management approach, the importance of not underestimating psychological harm in incidents of a prolonged duration and embedding the existing legislation pertaining to the rights of the child. (shrink)

Since the World Health Organization first declared the novel coronavirus a pandemic, diverse strategies have emerged to address it. This paper focuses on two leading strategies, elimination and mitigation, and examines their ethical basis. Elimination or ‘Zero-COVID’ dominates policies in Pacific Rim societies. It sets as a goal zero deaths and seeks to contain transmission using stringent short-term lockdowns, followed by strict find, test, trace and isolate methods. Mitigation, which dominates in the US and most European nations, sets targets for (...) community transmission and lifts restrictions once targets are met. This approach takes calculated risks and regards a certain amount of disease and death as ethically justified. Section I examines different societal responses to risk that underlie these different policy approaches. Section II focuses on ethical arguments favouring Zero-COVID and raises health equity objections. Section III proposes a long-term strategy that balances the twin goals of promoting population health and health equity. There are no data available for this work. (shrink)

The purpose of this article is to offer an alternative, more nuanced analysis of the labelling of frontline workers as heroes than originally proposed. Here, we argue that the hero narrative in itself need not be problematic, but highlight a number of wider factors that have led to the initial rise in support for labelling frontline workers as heroes. Through our related work, we have gathered similar stories from frontline workers where they feel betrayed, let down or otherwise short-changed by (...) the hero label, and we have sought to make sense of this through understanding more about how the hero label is used rather than what it means. In this article, we propose a way forward where there is greater discussion around the hero label in this context where individuals can be heroes but still struggle, still fail and still feel vulnerable, and where heroism is viewed as a state of interdependence between heroic actor and the wider group. It is true that heroes can inspire, lead, guide and build morale and camaraderie, but collective responsibility is held with us all. We can draw hope and energy from our heroes, but we must dig deep and be proactive, particularly in the face of adversity. In doing so, we support the heroes to lead from the front and ensure that even though we cannot physically help; we are not making their situation worse. (shrink)

Jecker and Au’s paper raises important issues concerning health equity in pandemic responses, and the importance of considering the long-term effects of pandemic strategy on population health and well-being.1 We welcome their focus on the experience of Asian countries, including Japan. However, we have some concerns with both the distinction which they draw between elimination and mitigation, and their account of the nature and origins of the Japanese response to the COVID-19 pandemic. First, we believe that the distinction between elimination (...) and mitigation is not fine grained enough to capture the various strategies which countries have taken towards the pandemic. Many of Jecker and Au’s criticisms of the elimination strategy relate to specific policies such as lockdowns, travel restrictions and restrictions on businesses, which have been employed by numerous countries irrespective of their end goal. By contrast to the simple elimination/mitigation dichotomy with which Jecker and Au work, Baker et al have identified five separate COVID-19 strategies, namely: exclusion, elimination, suppression, mitigation and no substantive strategy.2 Baker et al define an elimination strategy as ‘maximum action to exclude disease and eliminate community transmission’ with the goal of reaching ‘zero [disease] transmission in the community’. On this account, Japan’s strategy does …. (shrink)

Madison Kilbride recently argued that insurance ) should cover in vitro fertilisation with preimplantation genetic testing services for couples at high risk of having a child affected with a genetic condition. She argues that IVF-PGT meets CMS’s definition of ‘medically necessary care’, where such care includes ‘services or supplies needed to diagnose or treat an illness, injury, condition, disease or its symptoms’. Kilbride argues that IVF-PGT satisfies this definition in two ways: as a diagnostic tool and as a treatment. Contradicting (...) Kilbride, however, I argue that IVF-PGT provides neither diagnosis nor treatment under CMS’s definition. Thus, as long as we accept CMS’s definition of medically necessary care—which Kilbride does, explicitly—it follows that IVF-PGT does not count as medically necessary care. Still, there may be other reasons to conclude that IVF-Preimplantation genetic testing should be covered, and so, it would be a mistake to reject Kilbride’s conclusion altogether. The problem is simply that Kilbride’s argument—that the procedure should be covered because it is medically necessary per CMS’s definition—is not sound. I conclude by discussing a number of other genetic services that are not currently being covered despite the fact that they do seem to satisfy CMS’s definition of ‘medically necessary diagnosis or treatment’. These services, I argue, should be provided under CMS before we consider expanding coverage to include elective procedures such as IVF-PGT. (shrink)

There will always be debates in medical ethics about whether any particular value can be considered foundational, but there are reasons for thinking that ‘trust’ is the ground upon which many other important values is built. Sisela Bok remarks: > If there is no confidence in the truthfulness of others, is there any way to assess their fairness, their intentions to help or to harm? How, then, can they be trusted? Whatever matters to human beings, trust is the atmosphere in (...) which it thrives.1 p31 The idea that trust in what others tell us is the bedrock on which human relationships and other values are built seems plausible, but how trust is created, nurtured and sustained is perhaps the challenge for medical ethics. Annette Baier noted that trust occurs within the context of a relationship of some sort, be that with another person or an institution. > “Trust me!” is for most of us an invitation which we cannot accept at will—either we do already trust the one who says …. (shrink)

Public benefit corporations are National Health Service, that is, state, entities whose function to provide healthcare in discharge of public duties. If we regard value as the output of such organisations, it seems logical to connect the values of the organisation to the value produced by such organisations. But, on closer examination there are competing underlying logics in play: those based on promoting organisational efficiency and efficacy; and those based on the idea of building service provision around the clinician–patient relationship. (...) Underlying these logics are differing value sets. These clash. Because of the clashing of underlying moral frameworks the connection between values and value becomes hard, if not impossible. This paper argues that the clash in these moral frameworks must be addressed by the organisation rather than between individuals or groups of individuals within the organisation; alloying duties within hybrid professionals submerges but does not resolve these conflicts; one approach could be to impose on the organisation itself an ethical imperative to promote, enhance and protect from deterioration the welfare of the patients; a board ethics committee is a possible organisational structure that could transparently and fairly balance clashes within the competing moral frameworks in a way that could reconcile the competing logics and if such conflicts can be better resolved at the organisational level what the organisation must do to achieve its objectives will become clearer because what needs to be valued would naturally emerge connecting values, value and what is valued. (shrink)

The capacity to designate a surrogate is not simply another kind of medical decision-making capacity. A patient with DMC can express a preference, understand information relevant to that choice, appreciate the significance of that information for their clinical condition, and reason about their choice in light of their goals and values. In contrast, a patient can possess the CDS even if they cannot appreciate their condition or reason about the relative risks and benefits of their options. Patients who lack DMC (...) for many or most kinds of medical choices may nonetheless possess the CDS, particularly since the complex means-ends reasoning required by DMC is one of the first capacities to be lost in progressive cognitive diseases. That is, patients with significant cognitive decline or mental illness may still understand what a surrogate does, express a preference about a potential surrogate, and be able to provide some kind of justification for that selection. Moreover, there are many legitimate and relevant rationales for surrogate selection that are inconsistent with the reasoning criterion of DMC. Unfortunately, many patients are prevented from designating a surrogate if they are judged to lack DMC. When such patients possess the CDS, this practice is ethically wrong, legally dubious and imposes avoidable burdens on healthcare institutions. There are no data in this work. (shrink)

Direct-to-consumer genetic testing is a growing phenomenon, fuelled by the notion that knowledge equals control. One ethical question that arises concerns the proband’s duty to share information indicating genetic risks in their relatives. However, such duties are unenforceable and may result in the realisation of anticipated harm to relatives. We argue for a shift in responsibility from proband to provider, placing a duty on test providers in the event of identified actionable risks to relatives. Starting from Parker and Lucassen’s 'joint (...) account model', we adapt Kilbride’s application of the rule of rescue and balance it against the relative’s right not to know, placing responsibility on the providers of direct-to-consumer genetic testing. Where the risk of disease to a relative is actionable, we argue providers ought to share results even in the face of the proband’s objections. Confidentiality issues are navigated by a pre-emptive consent model, whereby consumers agree to the sharing of certain information with their relatives ahead of testing and as a condition of testing. When a relative is informed, the proband’s privacy is protected by maximal deidentification, and the rights of the relative are met by a stepwise approach to informing that allows them to decide how much information they receive. (shrink)

COVID-19 has stolen millions of lives and devastated livelihoods around the world and led to the exacerbation of existing inequities within and between countries. This part of a tragic pattern in catastrophes, where the most vulnerable populations are typically the ones to bear the greatest burdens. Jecker and Au1 offer a keen observation of how one particular COVID-19 response—Zero COVID—appears particularly problematic from a health equity perspective. Under Zero COVID, countries enact stringent lockdowns and movement restrictions in order to keep (...) cases as low as possible. Yet such restrictive policies hurt disadvantaged populations the most, by severely curtailing their ability to earn a living and forcing them to remain in cramped living spaces for potentially extended periods of time. However, the link between Zero COVID and health inequity is more complex than it might at first appear. This is because Zero COVID is itself compatible with meaningful efforts to mitigate inequities, including those caused by Zero COVID policies themselves. Conversely, certain inequities seemingly characterised by Zero COVID may persist even when Zero COVID is abandoned, indicating their ultimate root and …. (shrink)

WHO in 2019 established the Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing, which has recently published a Draft Governance Framework on Human Genome Editing. Although the Draft Framework is a good point of departure, there are four areas of concern: first, it does not sufficiently address issues related to establishing safety and efficacy. Second, issues that are a source of tension between global standard setting and state sovereignty need to be addressed in a (...) more nuanced fashion. Third, it fails to meaningfully engage with the extent to which the conceptualisation of human dignity may justifiably vary between jurisdictions. Fourth, the meaning of harm to the interests of a future person requires clarity. Provided these four areas of concern can be addressed, the future of the global governance of human genome editing may hold promise. (shrink)

This paper is a response to a recent paper by Bobier and Omelianchuk in which they argue that the critics of Giubilini and Minerva’s defence of infanticide fail to adequately justify a moral difference at birth. They argue that such arguments would lead to an intuitively less plausible position: that late-term abortions are permissible, thus creating a dilemma for those who seek to argue that birth matters. I argue that the only way to resolve this dilemma, is to bite the (...) naturalist bullet and accept that the intuitively plausible idea that birth constitutes a morally relevant event is simply mistaken and biologically misinformed. (shrink)

The current SARS-CoV-2 pandemic has killed thousands across the world. SARS-CoV-2 is the latest but surely not the last such global pandemic we will face. The biomedical response to such pandemics includes treatment, vaccination, and so on. In this paper, though, we argue that it is time to consider an additional strategy: the somatic enhancement of human immunity. We argue for this approach and consider bioethics objections we believe can be overcome.

In his paper, ‘Twin pregnancy, fetal reduction and the ‘all or nothing problem’, Räsänen sets out to apply Horton’s ‘all or nothing’ problem to the ethics of multifetal pregnancy reduction from a twin to a singleton pregnancy. Horton’s problem involves the following scenario: imagine that two children are about to be crushed by a collapsing building. An observer would have three options: do nothing, save one child by allowing their arms to be crushed, or save both by allowing their arms (...) to be crushed. Horton offers two intuitively plausible claims: it is morally permissible not to save either child and it is morally impermissible to save only one of the children, which taken together lead to the problematic conclusion that if an observer does not save both children, then it is better to save neither than save only one. Räsänen applies this problem to the case of 2-to-1 MFPR, arguing ultimately that, in cases where there is no medical reason to reduce, the woman ought to bring both fetuses to term. We will argue that Räsänen does not provide adequate support for the claim, crucial to his argument, that aborting only one of the fetuses in a twin pregnancy is wrong, so the ‘all or nothing’ problem does not arise in this context. Furthermore, we argue that the scenario Räsänen presents is highly unrealistic because of the clinical realities of 2-to-1 MFPR, making his argument of limited use for real-life decision making in this area. (shrink)

The National Institute for Health and Care Excellence, the UK’s main healthcare priority-setting body, recently reaffirmed a longstanding claim that in recommending technologies to the National Health Service it cannot apply the ‘rule of rescue’. This paper explores this claim by identifying key characteristics of the rule and establishing to what extent these are also features of NICE’s approach to evaluating ultra-orphan drugs through its highly specialised technologies programme. It argues that although NICE in all likelihood does not act because (...) of the rule in prioritising these drugs, its actions in relation to HSTs are nevertheless in accordance with the rule and are not explained by the full articulation of any alternative set of rationales. That is, though NICE implies that its approach to HSTs is not motivated by the rule of rescue, it is not explicit about what else might justify this approach given NICE’s general concern with overall population need and value for money. As such, given NICE’s reliance on notions of procedural justice and its commitment to making the reasons for its priority-setting decisions public, the paper concludes that NICE’s claim to reject the rule is unhelpful and that NICE does not currently meet its own definition of a fair and transparent decision-maker. (shrink)

It is hard to argue with the proposition that value for money should guide health spending. However, even after decades of development, economic evaluation is still a work in progress. As applied, it deals poorly with issues of social justice, ageing and end of life issues; cases involving small numbers—such as decisions about orphan drugs—are also contested. Unfortunately, differences in incremental cost-effectiveness ratios are presented with a degree of precision which contributes to an ‘illusion of validity’.1 Nobel Laureate Amartya Sen (...) has suggested that ‘when all the requirements of ubiquitous market-centred evaluation have been incorporated into the procedures of cost–benefit analysis, it is not so much a discipline as a daydream’.2 As with any approach to public decision making, the use of economic evaluation rests on an implicit social licence, including that the decision making is fair and reasonable. Many countries have developed special policies for rare, ‘ultrarare’ or ‘orphan’ diseases to moderate the effect of a ubiquitous application of economic evaluation. The threshold for defining ‘small’ or rare is a matter of judgement and ranges between 2 and 80 per 100 000 population.3 Magalhaes challenges the ethical basis of special programmes for low incidence conditions and argues against such provisions. In this commentary, I will argue the contrary: that there are good reasons …. (shrink)

In June 2021, an 1856 British Guiana 1c magenta stamp sold for US$8.3m. It is the only known specimen of its kind in existence and on a gram-for-gram basis the most valuable item in the world. Clearly, in some spheres of human engagement, rarity carries a premium. Should this logic be applied in healthcare? Magalhaes thinks not.1 They explore the topic of whether pricing and reimbursement systems should give a premium to orphan drugs for rare diseases. They argue that rarity (...) is irrelevant to pharmaceutical policy on ethical grounds, and instead drug incentives should be prioritised by disease severity. At a time when incentives for orphan medicines are being revisited globally, Magalhaes is provoking an important discussion. The author seeks to disentangle the interwoven concepts of rarity, severity and unmet need that factor into decisions on orphan drug policy. They perhaps overstate the emphasis on rarity within existing regulatory and P&R frameworks. Yes, this is one of the criteria for orphan drug designation, but in payer systems rarity is seldom explicitly referenced. For example, of the five largest European countries, only the United Kingdom formally adjusts willingness-to-pay thresholds by prevalence. In contrast, concepts of severity and unmet need feature widely in global regulatory processes (eg, Breakthrough Therapy designation from …. (shrink)

Many high-risk medical devices earn US marketing approval based on limited premarket clinical evaluation that leaves important questions unanswered. Rigorous postmarket surveillance includes registries that actively collect and maintain information defined by individual patient exposures to particular devices. Several prominent registries for cardiovascular devices require enrolment as a condition of reimbursement for the implant procedure, without informed consent. In this article, we focus on whether these registries, separate from their legal requirements, have an ethical obligation to obtain informed consent from (...) enrolees, what is lost in not doing so, and the ways in which seeking and obtaining consent might strengthen postmarket surveillance in the USA. (shrink)

Orphan drug policy often gives ‘special treatment’ to rare diseases, by giving additional priority or making exceptions to specific drugs, based on the rarity of the conditions they aim to treat. This essay argues that the goal of orphan drug policy should be to make prevalence irrelevant to funding decisions. It aims to demonstrate that it is severity, not prevalence, which drives our judgments that important claims are being overlooked when treatments for severe rare diseases are not funded. It shows (...) that prioritising severity avoids problems caused by prioritising rarity, and that it is compatible with a range of normative frameworks. The implications of a severity-based view for drug development are then derived. The severity-based view also accounts for what is wrong with how the current system of drug development unfairly neglects common diseases that burden the developing world. Lastly, the implications of a severity-based view for current orphan drug policies are discussed. There are no data in this work. (shrink)

I argue that Schmidt et al, while correctly diagnosing the serious racial inequity in current ventilator rationing procedures, misidentify a corresponding racial inequity issue in alternative ‘unweighted lottery’ procedures. Unweighted lottery procedures do not ‘compound’ prior structural injustices. However, Schmidt et al do gesture towards a real problem with unweighted lotteries that previous advocates of lottery-based allocation procedures, myself included, have previously overlooked. On the basis that there are independent reasons to prefer lottery-based allocation of scarce lifesaving healthcare resources, I (...) develop this idea, arguing that unweighted lottery procedures fail to satisfy healthcare providers’ duty to prevent unjust population-level health outcomes, and thus that lotteries weighted in favour of Black individuals are to be preferred. (shrink)

In a recent judgment1 the Court of Protection was highly critical of health professionals for continuing to provide clinically-assisted nutrition and hydration in the face of disagreement about the patient’s best interests, without seeking to resolve the issue. This hearing had been set up specifically to consider whether GU’s dignity had been properly protected, and if not why not, given concerns raised by the Official Solicitor about what she considered to be “a complete abrogation of responsibility to consider properly or (...) at all, and to determine whether it was in GU’s best interests and therefore lawful to continue to give him an invasive medical treatment, CANH.” In April 2014, at 63 years old and living in Thailand, GU sustained severe injuries after suffering from an electrocution accident. He sustained a cardiorespiratory arrest with a significant delay before cardiopulmonary resuscitation was started and was unconscious and unresponsive. In September 2014 he was transferred to the UK. In August 2018, GU’s brother made a request for a best interests decision concerning the continuation of CANH. The family met to discuss this and all except GU’s son, agreed that continuing CANH was not in GU’s best interests. In view of the fact that there was not unanimity among the family, a decision was made that CANH should continue. Commenting on this decision, Mr Justice Hayden said ‘the apparent assumption that in the face of family disagreement ‘ therefore will continue to be cared for by nursing staff ” is a troubling non sequitur’ and stressed that ‘family dissent to a medical consensus should never stand in the way of an incapacitated patients’ best interests being properly identified’. He also made clear that the responsibility for ensuring that a best interests assessment is undertaken rests with the …. (shrink)

There have been calls for mandatory vaccination legislation to be introduced into the UK in order to tackle the national and international rise of vaccine-preventable disease. While some countries have had some success associated with mandatory vaccination programmes, the Royal College of Paediatrics and Child Health insist this is not a suitable option for the UK, a country which has seen historical opposition to vaccine mandates. There is a lack of comprehensive data to demonstrate a direct link between mandatory vaccination (...) legislation and increased uptake. While there are examples whereby there has been an improvement, some studies suggest that comparable results can be obtained by strongly recommending vaccinations instead. The RCPCH insist that healthcare workers are ideally placed to engage and inform parents to make every interaction a ‘vaccine opportunity’. This paper calls for a principled, rational approach to interpretations of autonomy which underpin parental informed consent. MacLean’s concept of mutual persuasion could be a vehicle to ensuring parents are suitably informed of both the material risks associated with vaccine choices and to consider the rationality of their decisions, while ultimately upholding parental autonomy. It is argued that this, alongside infrastructural improvement, could create a more sustainable, long-term improvement in childhood vaccination rates in the UK than mandatory vaccination. (shrink)

In the article, Twin pregnancy, fetal reduction and the ‘all or nothing problem’, I argued that there is a moral problem in multifetal pregnancy reduction from a twin to a singleton pregnancy. Drawing on Horton’s original version of the ‘all or nothing problem’, I argued that there are two intuitively plausible claims in 2-to-1 MFPR: aborting both fetuses is morally permissible, aborting only one of the twin fetuses is morally wrong. Yet, with the assumption that one should select permissible choice (...) over impermissible choice, the two claims lead to a counter-intuitive conclusion: the woman ought to abort both fetuses rather than only one. It would be odd to promote such a pro-death view. Begović _et al_ discuss my article and offer insightful criticism, claiming, that there is no ‘all or nothing problem’ present in 2-to-1 MFPR. In this short reply, I respond to some of their criticism. (shrink)

Fetal reduction is the practice of reducing the number of fetuses in a multiple pregnancy, such as quadruplets, to a twin or singleton pregnancy. Use of assisted reproductive technologies increases the likelihood of multiple pregnancies, and many fetal reductions are done after in vitro fertilisation and embryo transfer, either because of social or health-related reasons. In this paper, I apply Joe Horton’s all or nothing problem to the ethics of fetal reduction in the case of a twin pregnancy. I argue (...) that in the case of a twin pregnancy, there are two intuitively plausible claims: abortion is morally permissible, and it is morally wrong to abort just one of the fetuses. But since we should choose morally permissible acts rather than impermissible ones, the two claims lead to another highly implausible claim: the woman ought to abort both fetuses rather than only one. Yet, this does not seem right. A plausible moral theory cannot advocate such a pro-death view. Or can it? I suggest ways to solve this problem and draw implications for each solution. There are no data in this work. (shrink)

As the 20th century began, few effective therapies existed. This soon changed with major therapeutic discoveries turning the century into what has been called the golden age of therapeutics.1 The emphasis of most of these developments was on medicines for common disorders as they presented the greatest need. However, it also allowed pharmaceutical manufacturers to produce blockbuster drugs that provided a large return on investment. Rare disorders were overlooked because most are genetic in origin and scientific knowledge was lacking, making (...) it difficult to find treatments. The first genetic disorder with a therapy was phenylketonuria. The biochemist who proposed the first successful treatment in the 1950s was actively discouraged as phenylketonuria was genetic and ‘incurable’.2 Another reason was an absence of incentives to invest in developing medicines for which the return was limited, given the small numbers of potential patients. This changed from 1983 as several countries began introducing orphan drug policies, with Canada being a notable exception. As the millennium changed, some drugs for rare disorders were available, but the sequencing of the human genome in the early 2000s provided scientific knowledge to develop many more. The new therapies are often costly because they require millions, even billions, of dollars and years to develop, test and satisfy regulatory standards. …. (shrink)

In the article Should rare diseases get special treatment? by Monica Q F de Magalhaes,1 it is argued that rarity is not a morally relevant feature to consider in prioritising treatment in healthcare, but severity is. A central conclusion in the article is that severity rather than prevalence should guide different cost-effectiveness thresholds. Hence, I take it, she answers no to the question in her own heading. I agree with all of this—and with most of her other arguments and conclusions (...) in the article—except for the clause ‘rather than prevalence’. For this reason, I find the article misses its’ mark. Let me explain by taking Sweden as an example. Sweden has a legally established ethics framework for priority setting in healthcare since 1997, comprising three principles: human-dignity principle, needs-solidarity principle and cost-effectiveness principle. The implication of these principles in practice is that the higher the severity—the higher the cost-effectiveness threshold acceptable.2 During the last 10 years or so, the highest accepted cost-effectiveness threshold for the most severe conditions have been in the order of €100 000/QALY. Until a few years ago rarity or prevalence was …. (shrink)

We respond to recent comments on our proposal to improve justice in ventilator triage, in which we used as an example New Jersey’s publicly available and legally binding Directive Number 2020-03. We agree with Bernard Lo and Doug White that equity implications of triage frameworks should be continually reassessed, which is why we offered six concrete options for improvement, and called for monitoring the consequences of adopted triage models. We disagree with their assessment that we mis-characterised their Model Guidance, as (...) included in the NJ Directive, in ways that undermine our conclusions. They suggest we erroneously described their model as a two-criterion allocation framework; that recognising other operant criterion reveals it ‘likely mitigate[s] rather than exacerbate[s] racial disparities during triage’, and allege that concerns about inequitable outcomes are ‘without evidence’. We highlight two major studies robustly demonstrating why concerns about disparate outcomes are justified. We also show that White and Lo seek to retrospectively—and counterfactually—correct the version of the Model Guideline included in the NJ Directive. However, as our facsimile reproductions show, neither the alleged four-criteria form, nor other key changes, such as dropping the Sequential Organ Failure Assessment score, are found in the Directive. These points matter because our conclusions hence stand, because the public version of the Model Guidance had not been updated to reduce the risk of inequitable outcomes until June 2021 and NJ’s Directive still does not reflect these revisions, and, hence, represents a less equitable version, as acknowledged by its authors. We comment on broader policy implications and call for ways of ensuring accurate, transparent and timely updates for users of high-stakes guidelines. (shrink)

Withholding or withdrawing life-saving ventilators can become necessary when resources are insufficient. In the USA, such rationing has unique social justice dimensions. Structural elements of dominant allocation frameworks simultaneously advantage white communities, and disadvantage Black communities—who already experience a disproportionate burden of COVID-19-related job losses, hospitalisations and mortality. Using the example of New Jersey’s Crisis Standard of Care policy, we describe how dominant rationing guidance compounds for many Black patients prior unfair structural disadvantage, chiefly due to the way creatinine and (...) life expectancy are typically considered.We outline six possible policy options towards a more just approach: improving diversity in decision processes, adjusting creatinine scores, replacing creatinine, dropping creatinine, finding alternative measures, adding equity weights and rejecting the dominant model altogether. We also contrast these options with making no changes, which is not a neutral default, but in separate need of justification, despite a prominent claim that it is simply based on ‘objective medical knowledge’. In the regrettable absence of fair federal guidance, hospital and state-level policymakers should reflect on which of these, or further options, seem feasible and justifiable.Irrespective of which approach is taken, all guidance should be supplemented with a monitoring and reporting requirement on possible disparate impacts. The hope that we will be able to continue to avoid rationing ventilators must not stand in the way of revising guidance in a way that better promotes health equity and racial justice, both to be prepared, and given the significant expressive value of ventilator guidance. (shrink)

The fair distribution of health resources is critical to health justice. But distributing healthcare equitably requires careful attention to the existing distribution of other resources, and the economic system which produces these inequalities. Health is strongly determined by socioeconomic factors, such as the effects of racism on the health of communities of colour, as well as the broader market-oriented healthcare and pharmaceutical systems that put the pursuit of profit above the alleviation of suffering. Two papers in this issue confront health (...) injustices at different scales, and make far-reaching recommendations for more just healthcare allocation policies. Orphan drugs are those that pharmaceutical companies are unwilling to develop unless they are offered financial incentives to do so. When a target patient group is very small, or very poor, producing drugs is unprofitable. If patients are to benefit from these drugs in a marketised pharmaceutical regime, governments must step in to provide incentives for research and development. Yet government spending ought to prioritise value for money, and is generally guided by a utilitarian framework. In the case of neglected tropical diseases, there is no moral conflict: large numbers of people would benefit greatly from these treatments. However, there are practical limitations: the governments of affected populations are often unable to fund incentives for research and development, and solidarity from elsewhere is limited.1 2 In the case of rare diseases, Global North governments usually can afford to incentivise the development of treatments to serve their populations, but given the small numbers of beneficiaries, doing so seems a questionable use of resources. Many Global North governments make an exception to the general utilitarian heuristic to accommodate the moral intuition that the claims of a person with a rare …. (shrink)

Where a person is unable to make medical decisions for themselves, law and practice allows others to make decisions on their behalf. This is common at the end of a person’s life where decision-making capacity is often lost. A further, and separate, decision that is often considered at the time of death is whether the person wanted to act as an organ or tissue donor. However, in some jurisdictions, the lawful decision-maker for the donation decision is different from the person (...) who was granted decision-making authority for medical decisions during the person’s life. To date, little attention has been given in the literature to the ethical concerns and practical problems that arise where this shift in legal authority occurs. Such a change in decision-making authority is particularly problematic where premortem measures are suggested to maximise the chances of a successful organ donation. This paper examines this shift in decision-making authority and discusses the legal, ethical and practical implications of such frameworks. (shrink)

The field of clinical bioethics strongly advocates for the use of advance directives to promote patient autonomy, particularly at the end of life. This paper reports a study of clinical bioethicists’ perceptions of the professional consensus about advance directives, as well as their personal advance care planning practices. We find that clinical bioethicists are often sceptical about the value of advance directives, and their personal choices about advance directives often deviate from what clinical ethicists acknowledge to be their profession’s recommendations. (...) Moreover, our respondents identified a pluralistic set of justifications for completing treatment directives and designating surrogates, even while the consensus view focuses on patient autonomy. Our results suggest important revisions to academic discussion and public-facing advocacy about advance care planning. (shrink)

We wholeheartedly agree with Schmidt and colleagues’ efforts to promote equity in intensive care unit triage. We also take issue with their characterisation of the New Jersey allocation framework for ICU beds and ventilators, which is modelled after the multi-principle allocation framework we developed early in the pandemic. They characterise it as a two-criterion allocation framework and claim—without evidence—that it will ‘compound disadvantage for black patients’. However, the NJ triage framework—like the model allocation policy we developed—actually contains four allocation criteria: (...) the two criteria that the authors mentioned and two criteria that they failed to mention which we included to promote equity: giving priority to frontline essential workers and giving priority to younger patients. These omissions are problematic both for reasons of factual accuracy and because the two criteria they failed to acknowledge would likely mitigate rather than exacerbate racial disparities during triage. (shrink)

Gender dysphoria is a clinically significant incongruence between expressed gender and assigned gender, with rapidly growing prevalence among children. The UK High Court recently conducted a judicial review regarding the service provision at a youth-focussed gender identity clinic in Tavistock. The high court adjudged it ‘highly unlikely’ that under-13s, and ‘doubtful’ that 14–15 years old, can be competent to consent to puberty blocker therapy for GD. They based their reasoning on the limited evidence regarding efficacy, the likelihood of progressing to (...) cross-sex hormone therapy and the ‘life-changing consequences’ of puberty blockers. In this article, I offer two concurrent arguments to dispute their reasoning. First, I argue that minors can be competent to consent to puberty blockers for GD, because the decision to undergo puberty blocker therapy is no more complex or far-reaching than other medical decisions that we accept a child should be able to make. Second, I argue that—irrespective of competence—such legal restriction for all children fundamentally contradicts the central ethical tenet of child healthcare: best interests. For these two reasons, the high court should not restrict access to puberty blockers for competent GD children. All data relevant to the study are included in the article or uploaded as online supplemental information. This article uses no original data, thus, all data relevant to the study are available in the referenced studies. (shrink)

An increasing number of bioethicists are raising concerns that young childless women requesting sterilisation as means of birth control are facing unfair obstacles. It is argued that these obstacles are inconsistent, paternalistic, that they reflect pronatalist bias and that men seem to face fewer obstacles. It is commonly recommended that physicians should change their approach to this type of patient. In contrast, I argue that physicians’ reluctance to eagerly follow an unusual request is understandable and that whatever obstacles result from (...) this reluctance serve as a useful filter for women who are not seriously committed to their expressed requests for sterilisation. As women already disproportionally bear the birth control burden, less resistance that men might be getting in terms of voluntary sterilisation works to women’s advantage, providing a much needed balance. Societal attitudes towards women and motherhood should not be confused with individual physicians’ reasonable reluctance to jump at a serious elective procedure at fairly mild expression of interest. (shrink)

Medicine has historically been slow to adopt new technologies. Although telepsychiatry was already to some degree in use before the COVID-19 pandemic, the imposed limitations on person-to-person contacts accelerated its growth exponentially. Outcome studies have generally supported telepsychiatry’s use,1 but the breathtaking rapid shift from in-person to video visits across psychiatry has occurred prior to more in-depth examinations on the fundamental changes to the nature of the patient–physician interface. In their paper: “Can you hear me?”: communication, relationship and ethics in (...) video-based telepsychiatric consultations’, the authors aptly take this deep dive, carefully parsing out the potential areas of change from live visits to virtual sense by sense. The authors describe the sensory and spatial context of psychiatric consultation, where vision, hearing and even smell play a role in the assessment of the patient. Furthermore, they consider multiple aspects around telepsychiatric consultations, including technical and educational components for patients and clinicians, and highlight the ethical dimensions of a psychiatric consultation under this new model.2 How many clinical clues might a …. (shrink)

Childhood obesity is an increasing health problem. Prior empirical research suggests that, although discussing lifestyle behaviours with parents could help prevent childhood obesity and its health-related consequences, physicians are reluctant to address parental responsibility in the clinical setting. Therefore, this paper questions whether parents might be responsible for their children’s obesity, and if so, whether parental responsibility ought to be addressed in the physician–patient/parent encounter. We illustrate how different ideal-typical models of the physician–patient/parent interaction emphasise different understandings of patient autonomy (...) and parental responsibility and argue that these models advocate different responses to an appeal for discussing parents’ role in childhood obesity. We suggest that responsibility should be attributed to parents because of their parental roles in providing for their children’s welfare. We also argue that whether, and how, this responsibility gives rise to a requirement to act depends on the parents’ capacities. A deliberative-oriented physician–patient/parent interaction best captures the current ideals of antipaternalism, patient autonomy, and shared and evidence-informed decision-making, and might facilitate parental role development. We conclude that, while not discussing parental responsibility for childhood obesity in the clinical setting can be warranted in particular cases, this cannot be justified as a general rule. There are no data in this work. (shrink)

Choice is probably one of the most often discussed areas in bioethics, alongside the related concepts of informed consent and autonomy. It is generally, prima facie, portrayed as a good thing. In healthcare, the 2000s saw the UK Prime Minister Tony Blair pursue the ‘Choice Agenda’ where, ‘As capacity expands, so choice will grow. Choice will fundamentally change the balance of power in the NHS.’1 In a consumerist society giving consumers more choice is seen as desirable. However, choice is not (...) a good in itself, giving people more choice in certain situations can be problematic: i.e. consumerism drives economic growth and this has a detrimental effect on the environment; and increasing the range of choices a patient is offered is often not the best way to improve the quality of healthcare provision.2 The assumptions behind the valuing of choice need careful unpacking and this Issue of the Journal of Medical Ethics includes papers that explore choice in a number of areas. This Issue's Editor’s choice is Tom Walker’s ‘The Value of Choice’,3 which puts forward a suggestion for the importance of the symbolic value of choice. There are a number of ways of categorising the value of choice in healthcare. One account sees choice as valuable because it is by choosing that individuals make their life their own. Another account sees choice as valuable for instrumental reasons, people are generally, assuming they are sufficiently informed, the best judge of their own best interests. Walker argues for an additional third reason, the symbolic value of choice, originally proposed by Scanlon. This sees choice as valuable because being given the option to choose, whether or not one takes it up, not the act of choosing is what makes choice valuable. Being offered the option to choose has a …. (shrink)

Telepsychiatry has long been discussed as a supplement to or substitute for face-to-face therapeutic consultations. The current pandemic crisis has fueled the development in an unprecedented way. More and more psychiatric consultations are now carried out online as video-based consultations. Treatment results appear to be comparable with those of face-to-face care in terms of clinical outcome, acceptance, adherence and patient satisfaction. However, evidence on videoconferencing in a variety of different fields indicates that there are extensive changes in the communication behaviour (...) in online conversations. We hypothesise that this might impact ethically relevant aspects of the therapeutic relationship, which plays a prominent role in psychiatry. In this paper, we review effects of video-based consultations on communication between therapists and patients in psychiatry. Based on a common understanding of video-based consultations as changing the lived experience of communication, we categorise these effects according to sensory, spatial and technical aspects. Departing from a power-based model of therapeutic relationships, we then discuss the ethical significance of this changed communication situation, based on dimensions of respect for autonomy, lucidity, fidelity, justice and humanity. We conclude that there is evidence for ethically relevant changes of the therapeutic relationship in video-based telepsychiatric consultations. These changes need to be more carefully considered in psychiatric practice and future studies. (shrink)

Introduction International sharing of health data opens the door to the study of the so-called ‘Big Data’, which holds great promise for improving patient-centred care. Failure of recent data sharing initiatives indicates an urgent need to invest in societal trust in researchers and institutions. Key to an informed understanding of such a ‘social license’ is identifying the views patients and the public may hold with regard to data sharing for health research. Methods We performed a narrative review of the empirical (...) evidence addressing patients’ and public views and attitudes towards the use of health data for research purposes. The literature databases PubMed, Embase, Scopus and Google Scholar were searched in April 2019 to identify relevant publications. Patients’ and public attitudes were extracted from selected references and thematically categorised. Results Twenty-seven papers were included for review, including both qualitative and quantitative studies and systematic reviews. Results suggest widespread—though conditional—support among patients and the public for data sharing for health research. Despite the fact that participants recognise actual or potential benefits of data research, they expressed concerns about breaches of confidentiality and potential abuses of the data. Studies showed agreement on the following conditions: value, privacy, risk minimisation, data security, transparency, control, information, trust, responsibility and accountability. Conclusions Our results indicate that a social license for data-intensive health research cannot simply be presumed. To strengthen the social license, identified conditions ought to be operationalised in a governance framework that incorporates the diverse patient and public values, needs and interests. (shrink)

Scheduling surgical procedures among operating rooms is mistakenly regarded as merely a tedious administrative task. However, the growing demand for surgical care and finite hours in a day qualify OR time as a limited resource. Accordingly, the objective of this manuscript is to reframe the process of OR scheduling as an ethical dilemma of allocating scarce medical resources. Recommendations for ethical allocation of OR time—based on both familiar and novel ethical values—are provided for healthcare institutions and individual surgeons. All data (...) relevant to the study are included in the article. (shrink)

Although telepsychiatry consultations have been tried and tested for several years, at least in relatively limited numbers and settings, the current COVID-19 pandemic has caused an exponential increase in their application. Even as lockdown restrictions were lifted and a return to face-to-face consultations was possible, many practitioners and patients decided to uphold teleconsultations for some or a large part of their interactions. This was mostly driven by the exceptional circumstances of the pandemic, as ongoing safety concerns, the need for PPE (...) use and uncertainty around whether face-to-face meetings could go ahead continued to form barriers to usual care practices. Frittgen and Haltaufderheide aptly hypothesise that extensive changes in online communication behaviour will also impact ethical aspects of the therapeutic relationship.1 After considering how the use of technology may affect the therapeutic relationship in video-based consultations, they provide an ethical analysis of this impact along four dimensions: respect for autonomy, lucidity, fidelity and humanity.1 In this commentary I will have a look at the difference between crisis standards of care and usual care, the need to consider specific patient needs in teleconsultation use, the importance of justice understood as equity and access to technology, and a major challenge ahead. Throughout history, crisis situations have often been major catalysts of technological and other progress. Under challenging …. (shrink)

We proposed adding a sustainability principle to the operational ethical principles guiding public healthcare resources allocation decisions. All our commentators acknowledge our core message: healthcare needs to pay attention to the future. They also strengthen our proposal by offering support by luck egalitarian and Rawlsian arguments, and helpfully point out ambiguities and gaps requiring attention in the further development of the proposal, and its practical implementation.

We analysed all journals from two Journal Citation Reports categories: ‘Dentistry, Oral Surgery and Medicine’ and ‘Otorhinolaryngology’ published in 2018 for their policies on publishing facial photographs and actual practices of publishing these photographs in articles. We extracted the following data for each journal: JCR category, impact factor, volume, issue, instructions for authors regarding ethical issues, instructions for photograph deidentification, journals’ references to standard research and publishing policies, presence and type of published clinical images, separate informed consent for the publication (...) of patient photograph and methods of deidentification. The sample included 103 journals, which published 568 articles with 1404 clinical images. Around a half of the journals had a policy on clinical images, however, the only predictor of having a journal policy on clinical images was reference in the policy to International Committee of Medical Journal Editors Recommendations. Identifiable patient photographs were found in 13% of the articles, constituting 9% of the total sample of images. Only 16% of articles publishing recognisable patient facial images included a statement about consent for publication of the image. From the total sample of articles, 34% contained deidentified but recognisable patient photographs and only 22% of them had a statement about patient consent for photograph publication. The patients’ consent was more likely stated in the article in cases of recognisable facial images. Journals publishing clinical research involving the face and neck region need to establish and enforce policies on publishing clinical images. (shrink)

In this article, I describe and analyse the proposed new International Committee of Medical Journal Editors form for disclosing conflicts of interest and conclude that it has many flaws. The form does not mention ‘conflicts of interest’ even once in either its body or its title, it introduces a conceptually confused categorisation of different potential conflicts and it ignores future conflicts and intellectual biases. Finally, many of the authors of the new form have themselves failed to declare relevant potential conflicts (...) of interest. All data relevant to the study are included in the article. (shrink)

Purpose Scarce evidence exists regarding end-of-life decision in neurocritically ill patients. We investigated the factors associated with EOLD making, including the group and individual characteristics of involved healthcare professionals, in a multiprofessional neurointensive care unit setting. Materials and methods A prospective, observational pilot study was conducted between 2013 and 2014 in a 10-bed NICU. Factors associated with EOLD in long-term neurocritically ill patients were evaluated using an anonymised survey based on a standardised questionnaire. Results 8 physicians and 24 nurses participated (...) in the study by providing their ‘treatment decisions’ for 14 patients at several time points. EOLD was ‘made’ 44 times, while maintenance of life support 98 times. EOLD patterns were not significantly different between professional groups. The individual characteristics of the professionals had no significant impact on decisions to forgo or maintain life-sustaining therapy. EOLD was patient-specific, with the presence of acute life-threatening disease : 18.199, p=0.038) and low expected patient quality of life : 9.276, p=0.016) being significant and independent determinants for withholding or withdrawing life-sustaining treatment. Conclusions Our findings suggest that EOLD in NICU relies mainly on patient prognosis and not on the characteristics of the healthcare professionals. (shrink)

There is robust scientific evidence from meta-analyses in psychotherapy research that common factors such as the alliance between patients and therapists, empathy, goal consensus/collaboration, positive regard/affirmation and genuineness have a much greater effect on the overall psychotherapy outcome than the so-called specific factors like particular treatment methods or ingredients of therapy.1 The current evidence base also suggests that the effects of telepsychiatric treatment are comparable with those of face-to-face treatment, not only regarding clinical outcome parameters but also with respect to (...) patient satisfaction, acceptance and adherence—all common factors of psychotherapy.2 According to a comprehensive review of the main ethical arguments for and against different forms of online psychotherapy, the online setting provides several weighty advantages: for example, increased access, availability, flexibility, convenience, satisfaction, acceptance and increased demand.3 Among the arguments against online psychotherapy, privacy, confidentiality and data security issues, emergency issues, as well as communication issues have been mentioned.3 Frittgen and Haltaufderheide 4 are concerned that telepsychiatry could ‘impact ethically relevant aspects of the therapeutic relationship’. They conclude that ‘there is evidence for ethically relevant changes of the therapeutic relationship in video-based telepsychiatric consultations’,4 particularly pertaining to ‘respect for autonomy, lucidity, fidelity, justice and humanity towards each other’.4 Indeed, video-based consultations as technically mediated communication ‘do not only transmit but transform what can be perceived, …. (shrink)

Background The idea that individuals are responsible for their health has been the focus of debate in the theoretical literature and in its concrete application to healthcare policy in many countries. Controversies persist regarding the form, substance and fairness of allocating health responsibility to the individual, particularly in universal, need-based healthcare systems. Objective To examine how personal health responsibility has been framed and rationalised in Norwegian key policy documents on priority setting. Methods Documents issued or published by the Ministry of (...) Health and Care Services between 1987 and 2018 were thematically analysed. We developed a predefined conceptual framework that guided the analysis. The framework included: the subject and object of responsibility, the level of conceptual abstraction, temporality, normative justificatory arguments and objections to the application of personal health responsibility. Results As an additional criterion, personal health responsibility has been interpreted as relevant if: the patient’s harmful behaviour is repeated after receiving treatment, and if the success of the treatment is conditional on the patient’s behavioural change. When discussed as a retrospective criterion, considerations of reciprocal fairness have been dominant. When discussed as a prospective criterion, the expected benefit of treatment justified its relevance. Conclusion Personal health responsibility appears to challenge core values of equality, inclusion and solidarity in the Norwegian context and has been repeatedly rejected as a necessary criterion for priority setting. However, the responsibility criterion seems to have some relevance in particular priority setting decisions. (shrink)

The COVID-19 pandemic has had, and still has, the risk to have an enormous impact on how people socially interact with each other due to possible lockdowns, quarantine and isolation measures to reduce infection rates. Consequently, these measures hold great implications for those medical disciplines that inherently rely on social interaction, such as psychiatry. In their article, ‘Can you hear me?’— Communication, Relationship and Ethics in Video-based Telepsychiatric Consultations’, Frittgen and Haltaufderheide1 show that videoconferencing holds potential to ensure that this (...) social interaction is guaranteed, be it in a technology mediated manner. In this sense, videoconferencing needs to be conceived as a pharmakon, a medicine, having both curative and toxifying elements, depending on why and how it is used.2 For example, videoconferencing allows continuity of care when physical proximity is impossible. At the same time, it allows the patient to interrupt the therapy by muting the therapist or ending the call at his/her convenience. To guarantee the curative side of videoconferencing, and as such avoid the toxifying elements, an ethical prescription needs to be developed and used. Despite the fact that videoconferencing seems to have a similar clinical effectiveness as face-to-face interaction, Frittgen and Haltaufderheide rightly point out that there are ethical impacts to be addressed to avoid …. (shrink)

Accounts of the value of patient choice in contemporary medical ethics typically focus on the act of choosing. Being the one to choose, it is argued, can be valuable either because it enables one to bring about desired outcomes, or because it is a way of enacting one’s autonomy. This paper argues that all such accounts miss something important. In some circumstances, it is having the opportunity to choose, not the act of choosing, that is valuable. That is because in (...) many situations whether one has, or is denied, that opportunity conveys how one is seen. In particular, it conveys whether or not one is seen as an equal and competent member of society. Adequately recognising this fact has implications for what healthcare professionals should do, ones that require a move away from the current focus on autonomy. The paper draws out these implications by focusing on patients who may struggle to be recognised as competent and equal members of society, and whose autonomy may thus itself sometimes be in question. (shrink)

Proponents of vaccine mandates typically claim that everyone who can be vaccinated has a moral or ethical obligation to do so for the sake of those who cannot be vaccinated, or in the interest of public health. I evaluate several previously undertheorised premises implicit to the ‘obligation to vaccinate’ type of arguments and show that the general conclusion is false: there is neither a moral obligation to vaccinate nor a sound ethical basis to mandate vaccination under any circumstances, even for (...) hypothetical vaccines that are medically risk-free. Agent autonomy with respect to self-constitution has absolute normative priority over reduction or elimination of the associated risks to life. In practical terms, mandatory vaccination amounts to discrimination against healthy, innate biological characteristics, which goes against the established ethical norms and is also defeasible a priori. (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)

This article discusses the triage response to the COVID-19 delta variant surge of 2021. One issue that distinguishes the delta wave from earlier surges is that by the time it became the predominant strain in the USA in July 2021, safe and effective vaccines against COVID-19 had been available for all US adults for several months. We consider whether healthcare professionals and triage committees would have been justified in prioritising patients with COVID-19 who are vaccinated above those who are unvaccinated (...) in first-order or second-order triage. Given that lack of evidence for a correlation between short-term survival and vaccination, we argue that using vaccination status during first-order triage would be inconsistent with accepted triage standards. We then turn to notions of procedural fairness, equity and desert to argue that that there is also a lack of justification for using vaccination status in second-order triage. In planning for future surges, we recommend that medical institutions base their triage decisions on principles meant to save the most lives, minimise inequity and protect the public’s trust, which for the time being would not be served by the inclusion of vaccination status. (shrink)