Developments in medical big data analytics may bring societal benefits but are also challenging privacy and other ethical values. At the same time, an overly restrictive data protection regime can form a serious threat to valuable observational studies. Discussions about whether data privacy or data solidarity should be the foundational value of research policies, have remained unresolved. We add to this debate with an empirically informed ethical analysis. First, experiences with the implementation of the General Data Protection Regulation (GDPR) within (...) a European research consortium demonstrate a gap between the aims of the regulation and its effects in practice. Namely, strictly formalised data protection requirements may cause routinisation among researchers instead of substantive ethical reflection, and may crowd out trust between actors in the health data research ecosystem; while harmonisation across Europe and data sharing between countries is hampered by different interpretations of the law, which partly stem from different views about ethical values. Then, building on these observations, we use theory to argue that the concept of trust provides an escape from the privacy-solidarity debate. Lastly, the paper details three aspects of trust that can help to create a responsible research environment and to mitigate the encountered challenges: trust as multi-agent concept; trust as a rational and democratic value; and trust as method for priority setting. Mutual cooperation in research—among researchers and with data subjects—is grounded in trust, which should be more explicitly recognised in the governance of health data research. (shrink)

New technologies create new complexities. Since non-invasive prenatal tests (NIPTs) were first introduced, keeping pace with complexity constitutes an ongoing task for medical societies, politics, and practice. NIPTs analyse the chromosomes of the fetus from a small blood sample. Initially, NIPTs were targeted at detecting trisomy 21 (Down syndrome): meanwhile there are sequencing techniques capable of analysing the entire genome of the unborn child. These yield findings of unclear relevance for the child’s future life, resulting in new responsibility structures and (...) dilemmas for the parents-to-be.The industry’s marketing strategies overemphasize the benefits of the tests while disregarding their consequences. This paper chooses the opposite path: starting with the underestimated consequences, it focuses on adverse developments and downsides. Disparities, paradoxes, and risks associated with NIPTs are illustrated, ethical conflicts described. Indications that new technologies developed to solve problems create new ones are examined. In the sense of critical thinking, seemingly robust knowledge is scrutinized for uncertainties and ambiguities. It analyses how the interplay between genetic knowledge and social discourse results in new dimensions of responsibility not only for parents-to-be, but also for decision-makers, authorities, and professional societies, illustrated by a review of different national policies and implementation programmes. As shown by the new NIPT policy in Norway, the consequences can be startling. Finally, a lawsuit in the United States illustrates how an agency can risk forfeiting its legitimation in connection with the inaccuracy of NIPTs. (shrink)

The dominant idea in debates on social inclusion of people with intellectual disabilities is that social inclusion requires recognition of their ‘sameness’. As a result, most care providers try to enable people with intellectual disabilities to live and participate in ‘normal’ society, ‘in the community’. In this paper, we draw on (Pols, Medicine Health Care and Philosophy 18:81–90, 2015) empirical ethics of care approach to give an in-depth picture of places that have a radically different take on what social inclusion (...) for people with intellectual disabilities looks like: places known as ‘sheltered living institutions’. We argue these places can be seen as ‘communities of difference’ catered to the specific needs and capacities of the residents. We then contend that these communities raise questions about what a good life for people with intellectual disabilities looks like and where and how it ought to be realised; questions not posed very often, as they get muzzled by the dominant rhetoric of normalisation and the emphasis on sameness. (shrink)

Moral injury is the trauma caused by violations of deeply held values and beliefs. This paper draws on relational philosophical anthropologies to develop the connection between moral injury and moral identity and to offer implications for moral repair, focusing particularly on healthcare professionals. We expound on the notion of moral identity as the relational and narrative constitution of the self. Moral identity is formed and forged in the context of communities and narrative and is necessary for providing a moral horizon (...) against which to act. We then explore the relationship between moral injury and damaged moral identities. We describe how moral injury ruptures one’s sense of self leading to moral disorientation. The article concludes with implications for moral repair. Since moral identity is relationally formed, moral repair is not primarily an individual task but requires the involvement of others to heal one’s identity. The repair of moral injury requires the transformation of a moral identity in community. (shrink)

In contemporary paternalism literature, persuasion is commonly not considered paternalistic. Moreover, paternalism is typically understood to be problematic either because it is seen as coercive, or because of the insult of the paternalist considering herself superior. In this paper, I argue that doctors who persuade patients act paternalistically. Specifically, I argue that trying to persuade a patient (here understood as aiming for the patient to consent to a certain treatment, although he prefers not to) should be differentiated from trying to (...) convince him (here understood as aiming for the patient to want the treatment) and recommending (the doctor merely providing her professional opinion). These three forms of influence are illustrated by summaries of video-recorded hospital encounters. While convincing and recommending are generally not paternalistic, I argue that persuasion is what I call communicative paternalism and that it is problematic for two reasons. First, the patient’s preferences are dismissed as unimportant. Second, the patient might wind up undergoing treatment against his preferences. This does not mean that persuasion always should be avoided, but it should not be undertaken lightly, and doctors should be aware of the fine line between non-paternalism and paternalism. The fact that my analysis of paternalism differs from traditional accounts does not imply that I deem these to be wrong, but rather that paternalism should be considered as a more multi-faceted concept than previous accounts allow for. (shrink)

In contemporary paternalism literature, persuasion is commonly not considered paternalistic. Moreover, paternalism is typically understood to be problematic either because it is seen as coercive, or because of the insult of the paternalist considering herself superior. In this paper, I argue that doctors who persuade patients act paternalistically. Specifically, I argue that trying to persuade a patient (here understood as aiming for the patient to consent to a certain treatment, although he prefers not to) should be differentiated from trying to (...) convince him (here understood as aiming for the patient to want the treatment) and recommending (the doctor merely providing her professional opinion). These three forms of influence are illustrated by summaries of video-recorded hospital encounters. While convincing and recommending are generally not paternalistic, I argue that persuasion is what I call communicative paternalism and that it is problematic for two reasons. First, the patient’s preferences are dismissed as unimportant. Second, the patient might wind up undergoing treatment against his preferences. This does not mean that persuasion always should be avoided, but it should not be undertaken lightly, and doctors should be aware of the fine line between non-paternalism and paternalism. The fact that my analysis of paternalism differs from traditional accounts does not imply that I deem these to be wrong, but rather that paternalism should be considered as a more multi-faceted concept than previous accounts allow for. (shrink)

I argue here that the impairment principle requires clarification. It needs to explain what makes one impairment greater than another, otherwise we will be unable to make the comparisons it requires, the ones that enable us to determine whether b really is a greater impairment than a, and as a result, whether causing b is immoral because causing a is. I then develop two of what I think are the most natural accounts of what might make one impairment greater than (...) another. The quantitative understanding of greater impairment is problematic because it leaves the impairment principle vulnerable to counterexamples; just because impairment b impairs a larger number of abilities or the same number of abilities but for a longer period or to a higher degree does not mean that b is a greater impairment than a. The qualitative understanding of greater impairment is problematic because it does not explain examples of greater impairment used in the literature, means that an abortion is always a qualitatively more severe impairment than causing fetal alcohol syndrome regardless of how the organism is affected, and/or entails that lethal impairment is always greater than nonlethal impairment. (shrink)

There is a long-standing debate concerning the eligibility of patients suffering from alcohol-related end-stage liver disease (ARESLD) for deceased donor liver transplantation. The question of retrospective and/or prospective responsibility has been at the center of the ethical discussion. Several authors argue that these patients should at least be regarded as partly responsible for their ARESLD. At the same time, the arguments for retrospective and/or prospective responsibility have been strongly criticized, such that no consensus has been reached. A third option was (...) proposed as a form of compromise, namely that responsibility should only be used as a tiebreaker in liver allocation. The present study provides an ethical investigation of this third option. First, we will provide an overview of the main arguments that have been offered for and against the use of responsibility as an allocation criterion. Second, we will explore the concept of responsibility as a tiebreaker in detail and discuss several types of situations, in which responsibility could be used as a tiebreaker, as well as the main ethical challenges associated with them. As we will show, an ethical justified use of responsibility as a tiebreaker is limited to a very restricted number of cases and is associated with a number of ethical concerns. For this reason, waiting time should be preferred as a tiebreaker in liver allocation, even though the criterion of waiting time, too, raises a number of equity-related concerns. (shrink)

Drug repurposing is a strategy of identifying new potential uses for already existing drugs. Many researchers adopted this method to identify treatment or prevention during the COVID-19 pandemic. However, despite the considerable number of repurposed drugs that were evaluated, only some of them were labeled for new indications. In this article, we present the case of amantadine, a drug commonly used in neurology that attracted new attention during the COVID-19 outbreak. This example illustrates some of the ethical challenges associated with (...) the launch of clinical trials to evaluate already approved drugs. In our discussion, we follow the ethics framework for prioritization of COVID-19 clinical trials proposed by Michelle N Meyer and colleagues (2021). We focus on four criteria: social value, scientific validity, feasibility, and consolidation/collaboration. We claim that launching amantadine trials was ethically justified. Although the scientific value was anticipated to be low, unusually, the social value was expected to be high. This was because of significant social interest in the drug. In our view, this strongly supports the need for evidence to justify why the drug should not be prescribed or privately accessed by interested parties. Otherwise, a lack of evidence-based argument could enhance its uncontrolled use. With this paper, we join the discussion on the lessons learned from the pandemic. Our findings will help to improve future efforts to decide on the launch of clinical trials on approved drugs when dealing with the widespread off-label use of the drug. (shrink)

In the initial phase of the COVID-19 pandemic, Sweden’s response stood out as an exception. For example, Sweden did not introduce any lockdowns, while many other countries did. In this paper I take the Swedish Corona Commission’s critique of the initial Swedish response as a point of departure for a general analysis of precaution in relation to pandemics. The Commission points out that in contrast to many other countries Sweden did not follow ‘the precautionary principle’. Based on this critique, the (...) Commission proposes that the precautionary principle should be included among Sweden’s guiding principles for crisis management. However, as the debate on this principle during the last 30 years indicates, the principle is loaded with problems. I discuss one of these problems, namely its lack of clarity. I argue, however, that this problem is not unsurmountable. A principle is lacking clarity precisely by being a principle and not a rule with a well-defined meaning. As a principle it indicates a direction but does not prescribe a specific action. However, to be action-guiding its content needs to be specified by rational deliberation. With this in mind, I propose a framework for specification of the precautionary principle as applied to pandemics. The framework focuses on the principle’s four key elements: threat, uncertainty, action and responsibility. I also suggest certain general ethical restrictions on specification. (shrink)

Researchers in applied ethics, and some areas of bioethics particularly, aim to develop concrete and appropriate recommendations for action in morally relevant real-world situations. When proceeding from more abstract levels of ethical reasoning to such concrete recommendations, however, even with regard to the very same normative principle or norm, it seems possible to develop divergent or even contradictory recommendations for action regarding a certain situation. This may give the impression that such recommendations would be arbitrary and, hence, not well justified. (...) Against this background, we, first, aim at showing that ethical recommendations for action, although being contingent in some sense, are not arbitrary if developed appropriately. For this purpose, we examine two types of contingencies arising in applied ethics reasoning based on recent examples of recommendations for action in the context of the COVID-19 pandemic. In doing so, we refer to a three-step model of ethical reasoning towards recommendations for actions. This, however, leaves open the question of how applied ethics may cope with contingent recommendations for action. Therefore, in a second step, we analyze the role of bridge principles for developing ethically appropriate recommendations for action, i.e., principles which connect normative claims with relevant empirical information to justify certain recommendations for action in a given morally relevant situation. Finally, we discuss some implications for reasoning and reporting in empirically informed ethics. (shrink)

Age-based rationing remains highly controversial. This question has been paramount during the Covid-19 pandemic. Analyzing the practices, proposals, and guidelines applied or put forward during the current pandemic, three kinds of age-based rationing are identified: an age-based cut-off, age as a tiebreaker, and indirect age rationing, where age matters to the extent that it affects prognosis. Where age is allowed to play a role in terms of who gets treated, it is justified either because this is believed to maximize benefits (...) from scarce resources or because it is believed to be in accordance with the value of fairness understood as (a) fair innings, where less priority is given to those who have lived a full life or (b) an egalitarian concern for the worse off. By critically assessing prominent frameworks and practices for pandemic rationing, this article considers the balance the three kinds of age-based rationing strike between maximizing benefits and fairness. It evaluates whether elements in the proposals are, in fact, contrary to the justifications of these measures. Such shortcomings are highlighted, and it is proposed to adjust prominent proposals to care for the worse off more appropriately and better consider whether the acquired benefits befalls the young or the old. (shrink)

Throughout the Global North, policymakers invest in large-scale integration of health-data infrastructures to facilitate the reuse of clinical data for administration, research, and innovation. Debates about the ethical implications of data repurposing have focused extensively on issues of patient autonomy and privacy. We suggest that it is time to scrutinize also how the everyday work of healthcare staff is affected by political ambitions of data reuse for an increasing number of purposes, and how different purposes are prioritized. Our analysis builds (...) on ethnographic studies within the Danish healthcare system, which is internationally known for its high degree of digitalization and well-connected data infrastructures. Although data repurposing ought to be relatively seamless in this context, we demonstrate how it involves costs and trade-offs for those who produce and use health data. Even when IT systems and automation strategies are introduced to enhance efficiency and reduce data work, they can end up generating new forms of data work and fragmentation of clinically relevant information. We identify five types of data work related to the production, completion, validation, sorting, and recontextualization of health data. Each of these requires medical expertise and clinical resources. We propose that the implications for these forms of data work should be considered early in the planning stages of initiatives for large-scale data sharing and reuse, such as the European Health Data Space. We believe that political awareness of clinical costs and trade-offs related to such data work can provide better and more informed decisions about data repurposing. (shrink)

AAL encompasses smart home technologies that are installed in the personal living environment in order to support older, disabled, as well as chronically ill people with the goal of delaying or reducing their need for nursing care in a care facility. Artificial intelligence (AI) is seen as an important tool for assisting the target group in their daily lives. A literature search and qualitative content analysis of 255 articles from computer science and engineering was conducted to explore the usage of (...) ethical concepts. From an ethical point of view, the concept of independence and self-determination on the one hand and the possible loss of privacy on the other hand are widely discussed in the context of AAL. These concepts are adopted by the technical discourse in the sense that independence, self-determination and privacy are recognized as important values. Nevertheless, our research shows that these concepts have different usages and meanings in the ethical and the technical discourses. In the paper, we aim to map the different meanings of independence, self-determination and privacy as they can be found in the context of technological research on AI-based AAL systems. It investigates the interpretation of these ethical and social concepts which technicians try to build into AAL systems. In a second step, these interpretations are contextualized with concepts from the ethical discourse on AI-based assistive technologies. (shrink)

Hospital acquired infections (HAIs) are a major threat to patient safety. This paper addresses the following question: given what is known about the causes of and possible interventions on HAIs, to whom or what should the moral responsibility for preventing these infections be attributed? First, we show how generating robust evidence on the effectiveness of preventive hygiene measures is a complex endeavour and review the existing evidence on the causes of HAIs. Second, we demonstrate that the existing literature on the (...) ethical aspects of infection control has focused on responsibility at the individual-level. Thirdly, we argue that these accounts do not accommodate systemic factors relevant for HAI prevention. We show that the notion of collective responsibility is useful for making understandable how systemic factors, such as employment conditions in hospitals, are both causally and ethically relevant in infection control. (shrink)

Empowerment, an already central concept in public health, has gained additional relevance through the expansion of mobile health (mHealth). Especially direct-to-consumer self-testing app companies mobilise the term to advertise their products, which allow users to self-test for various medical conditions independent of healthcare professionals. This article first demonstrates the absence of empowerment conceptualisations in the context of self-testing apps by engaging with empowerment literature. It then contrasts the service these apps provide with two widely cited empowerment definitions by the WHO, (...) which describe the term as a process that, broadly, leads to knowledge and control of health decisions. We conclude that self-testing apps can only partly empower their users, as they, we argue, do not provide the type of knowledge and control the WHO definitions describe. More importantly, we observe that this shortcoming stems from the fact that in the literature on mHealth and in self-testing marketing, empowerment is understood as a goal rather than a process. This characterises a shift in the meaning of empowerment in the context of self-testing and mHealth, one that reveals a lack of awareness for relational and contextual factors that contribute to empowerment. We argue that returning to a process-understanding of empowerment helps to identify these apps’ deficits, and we conclude the article by briefly suggesting several strategies to increase self-testing apps’ empowerment function. (shrink)

Despite the diversity of ageing, society and academics often describe and label older persons as a vulnerable group. As the term vulnerability is frequently interchangeably used with frailty, dependence, or loss of autonomy, a connection between older age and deficits is promoted. Concerning this, the question arises to what extent it may be helpful to refer to older persons as vulnerable specifically in the context of health care. After analyzing different notions of vulnerability, I argue that it is illegitimate to (...) conclude that older age is related to increased vulnerability. Much more, identifying older adults as a vulnerable group is closely related to ageism and can be associated with paternalistic benevolence and a tendency to overprotection, especially within health care. Additionally, even though older adults are more often in situations of increased vulnerability due to their potentially higher need for health care, I argue further that older adults mainly become a vulnerable group due to ageism. In this way, it can be concluded that the vulnerability of older adults does not originate in certain attributes of the group, but arises from a characteristic of society and, in turn, health personnel, namely ageism. Labeling older adults as vulnerable therefore is only helpful, when it is used to raise awareness of the widespread ageism in society, in this context, especially in the setting of health care, and the negative consequences thereof for older adults. (shrink)

In this paper, we discuss the lack of consideration given to children in the COVID-19 health systems policy response to the pandemic. We do this by focusing on the case of children with complex medical needs. We argue that, in broad terms, health systems policies that were implemented during the pandemic failed adequately to meet our obligations to both children generally and those with complex medical needs by failing to consider those needs and so to give them fair protection against (...) harm and disadvantage. We argue that justice requires that the distinct needs and vulnerabilities of children with medical complexities are explicitly integrated and prioritised in decisions concerning healthcare and operational planning in the recovery phase and beyond. (shrink)

Physician empathy is considered essential for good clinical care. Empirical evidence shows that it correlates with better patient satisfaction, compliance, and clinical outcomes. These data have nevertheless been criticized because of a lack of consistency and reliability. In this paper, we claim that these issues partly stem from the widespread idealization of empathy: we mistakenly assume that physician empathy always contributes to good care. This has prevented us from agreeing on a definition of empathy, from understanding the effects of its (...) different components and from exploring its limits. This is problematic because physicians’ ignorance of the risks of empathy and of strategies to manage them can impact their work and wellbeing negatively. To address this problem, we explore the effects of the potential components of empathy and argue that it should be conceived as a purely descriptive and wide term. We end by discussing implications for medical education. (shrink)

Informed consent (IC) is a key patients’ right. It gives patients the opportunity to access relevant information/knowledge and to support their decision-making role in partnership with clinicians. Despite this promising account of IC, the relationship between ‘knowledge’, as derived from IC, and the role of clinicians is often misunderstood. I offer two examples of this: (1) the prenatal testing and screening for disabilities; (2) the consent process in the abortion context. In the first example, IC is often over-medicalized, that is (...) to say the disclosure of information appears to be strongly in the clinicians’ hands. In this context, knowledge has often been a curse on prospective parents. Framing information in a doctor-centred and often negative way has hindered upon prospective parents’ decision-making role and also portrayed wrong assumptions upon disabled people more widely. In the second context, information is more often than not dismissed and, in a de-medicalized scenario, medical contribution often underplayed. The latter leads to an understanding of the dialogue with clinicians as a mere hinderance to the timely access to an abortion. Ultimately, I claim that it is important that knowledge, as derived from IC, is neither altogether dismissed via a process of de-medicalization, nor used as a curse on patients via a process of over-medicalization. None of the two gives justice to IC. Only when a better balance between medical and patients’ contribution is sought, knowledge can aspire to be a blessing (i.e. an opportunity for them), not a curse on patients in the IC context. (shrink)

In this paper, I explore the nature of medical interventions like neuromodulation on the complex human experience of love. Love is built upon two fundamental natures, viz: the biological and the psychosocial. As a result of this distinction, scientists, and bioethicists have been exploring the possible ways this complex human experience can be biologically tampered with to produce some supposed higher-order ends like well-being and human flourishing. At the forefront in this quest are Earp, Sandberg and Savulescu whose research works (...) over ten years has focused on the good that could stem from the medicalization of love. I acknowledge the various criticisms that have been made against this stance. However, most of these criticisms have been directed towards the mere side effects and sociocultural disservices that could result from the process of using drugs to influence human romantic relationships and in the end, critiques endorse the medicalization of love on the basis that its benefits outweigh the disadvantages. Consequently, I advance two strands of arguments against “medically-assisted love,” the ontological and the socio-ethical arguments. The former presupposes that beyond the possible side effects of medicalizing love there is something inherently mistaken about this effort and there is something intrinsically different about love that distinguishes it from its medically-engineered alternative. In the latter argument, I claim that drug interventions in romantic love contravene the very nature of medicine. Overall, I believe that critiques were still able to endorse medicalizing love despite their objections because they were only looking at one direction, the physical/cultural complications. (shrink)

Following the Second Summit on Human Gene Editing in Hong Kong in 2018, where the birth of two girls with germline genome editing was revealed, the need for a responsible pathway to the clinical application of human germline genome editing has been repeatedly emphasised. This paper aims to contribute to the ongoing discussion on research ethics issues in germline genome editing by exploring key issues related to the initial applications of CRISPR in reproductive medicine. Following an overview of the current (...) discussion on bringing germline genome editing into clinical practice, we outline the specific challenges associated with such interventions and the features that distinguish them from conventional clinical testing of new medical treatments. We then review proposed ethical requirements for initial heritable genome editing, such as the absence of reasonable alternatives, the existence of sufficient and reliable preclinical data, appropriate informed consent, requirements related to safety, and long-term follow-up. (shrink)

Casuistry, which involves analogical reasoning, is a popular methodological approach in bioethics. The method has its advantages and challenges, which are widely acknowledged. Meta-philosophical reflection on exactly how bioethical casuistry works and how the challenges can be addressed is limited. In this paper we propose a framework for structuring casuistry and analogical reasoning in bioethics. The framework is developed by incorporating theories and insights from the philosophy of science: Mary Hesse’s ideas on horizontal and vertical relations in analogical reasoning in (...) the sciences, Paul Bartha’s articulation model of analogical reasoning and Daniel Steel’s insights on mechanism-based extrapolation in biomedical research. Adopting our framework results in two practical benefits: it sets methodological standards for analogical reasoning and enables us to compare and evaluate diverging lines of analogical reasoning in a systematic way. Adopting the framework also has theoretical benefits: it helps to understand how analogical reasoning can have moral normativity; it pinpoints exactly where moral principles or theories enter analogical reasoning; and it helps to understand why casuistry is an attractive method in bioethics and in applied ethics more generally. (shrink)