Wendy A. Rogers

Many healthcare practices expose people to risks of harmful outcomes. However, the major theories of moral philosophy struggle to assess whether, when and why it is ethically justifiable to expose individuals to risks, as opposed to actually harming them. Sven Ove Hansson has proposed an approach to the ethical assessment of risk imposition that encourages attention to factors including questions of justice in the distribution of advantage and risk, people’s acceptance or otherwise of risks, and the scope individuals have to influence the practices that generate risk. This paper investigates the ethical justifiability of preventive healthcare practices that expose people to risks including overdiagnosis. We applied Hansson’s framework to three such practices: an ‘ideal’ breast screening service, a commercial personal genome testing service, and a guideline that lowers the diagnostic threshold for hypertension. The framework was challenging to apply, not least because healthcare has unclear boundaries and involves highly complex practices. Nonetheless, the framework encouraged attention to issues that would be widely recognised as morally pertinent. Our assessment supports the view that at least some preventive healthcare practices that impose risks including that of overdiagnosis are not ethically justifiable. Further work is however needed to develop and/or test refined assessment criteria and guidance for applying them.

BackgroundThere is a growing concern about artificial intelligence (AI) applications in healthcare that can disadvantage already under-represented and marginalised groups (eg, based on gender or race).ObjectivesOur objectives are to canvas the range of strategies stakeholders endorse in attempting to mitigate algorithmic bias, and to consider the ethical question of responsibility for algorithmic bias.MethodologyThe study involves in-depth, semistructured interviews with healthcare workers, screening programme managers, consumer health representatives, regulators, data scientists and developers.ResultsFindings reveal considerable divergent views on three key issues. First, views on whether bias is a problem in healthcare AI varied, with most participants agreeing bias is a problem (which we call the bias-critical view), a small number believing the opposite (the bias-denial view), and some arguing that the benefits of AI outweigh any harms or wrongs arising from the bias problem (the bias-apologist view). Second, there was a disagreement on the strategies to mitigate bias, and who is responsible for such strategies. Finally, there were divergent views on whether to include or exclude sociocultural identifiers (eg, race, ethnicity or gender-diverse identities) in the development of AI as a way to mitigate bias.Conclusion/significanceBased on the views of participants, we set out responses that stakeholders might pursue, including greater interdisciplinary collaboration, tailored stakeholder engagement activities, empirical studies to understand algorithmic bias and strategies to modify dominant approaches in AI development such as the use of participatory methods, and increased diversity and inclusion in research teams and research participant recruitment and selection.

An increasing number of patients receive diagnoses of disease without having any symptoms. These include diseases detected through screening programs, as incidental findings from unrelated investigations, or via routine checks of various biological variables like blood pressure or cholesterol. In this article, we draw on narrative identity theory to examine how the process of making sense of being diagnosed with asymptomatic disease can trigger certain overlooked forms of harm for patients. We show that the experience of asymptomatic disease can involve ‘mismatches’ between one’s beliefs about one’s health status on the one hand, and bodily sensations or past experience on the other. Patients’ attempts to integrate these diagnoses into their self-narratives often involve either forming inaccurate beliefs about bodily sensations and/or past experience, or coming to believe that feelings and experience do not necessarily track or predict health status, leading to an ongoing sense of vulnerability to ill health. These resulting alterations in self-understanding can sometimes be considered harmful, in view of their implications for ascriptions of responsibility and ongoing anxiety.

Patient or public involvement in health research is increasingly expected as a matter of policy. In theory, PPI can contribute both to the epistemic aims intrinsic to research, and to extrinsically valued features of research such as social inclusion and transparency. In practice, the aims of PPI have not always been clear, although there has been a tendency to encourage the involvement of so-called ordinary people who are regarded as representative of an assumed patient perspective. In this paper we focus on the epistemic potential of PPI, using theoretical work in epistemology to develop a nuanced account of patients’ experiential knowledge and how this might contribute directly to conceptual development, hypothesis generation and data interpretation. We also consider how some features of health research pose barriers to this kind of epistemic contribution. Drawing on Miranda Fricker’s idea of testimonial injustice, we explore how disciplinary indicators of credibility in clinical and academic health research contexts might be wrongly applied to those involved in PPI, undermining their potential to contribute. Finally we argue for a range of strategies to maximize opportunities for patients to engage with research teams and make epistemologically significant contributions to research.

Current practices of identifying and treating small indolent thyroid cancers constitute an important but in some ways unusual form of overdiagnosis. Overdiagnosis refers to diagnoses that generally harm rather than benefit patients, primarily because the diagnosed condition is not a harmful form of disease. Patients who are overdiagnosed with thyroid cancer are harmed by the psycho-social impact of a cancer diagnosis, as well as treatment interventions such partial or total thyroidectomy, lifelong thyroid replacement hormone, monitoring, surgical complications and other side effects. These harms seem to outweigh any putative benefit of knowing about a cancer that would not have caused problems if left undiscovered. In addition to harms to patients, thyroid cancer overdiagnosis leads to significant opportunity costs at a societal level, due to costs of diagnosis and treatment. Unlike many other overdiagnosed cancers, accurate risk stratification is possible with thyroid cancer. At the individual patient level, use of this risk information might support informed choice and/or shared decision-making, as mandated by clinical ethics frameworks. And this approach might, to some extent, help to reduce rates of diagnosis and intervention. In practice, however, it is unlikely to stem the rising incidence and associated harms and costs of overdiagnosed thyroid cancer, especially in situations where health professionals have conflicts of interest. We argue in this article that thyroid cancer overdiagnosis may be usefully understood as a public health problem, and that some public health approaches will be readily justifiable and are more likely to be effective in minimising its harms.

The Routledge Handbook of Feminist Bioethics is an outstanding resource for anyone with an interest in feminist bioethics, with chapters covering topics from justice and power to the climate crisis. Comprising 42 chapters by emerging and established scholars, the volume is divided into six parts: Foundations of Feminist Bioethics Identity and Identifications Science, Technology and Research Health and Social Care Reproduction and Making Families Widening the Scope of Feminist Bioethics The volume is essential reading for anyone with an interest in bioethics or feminist philosophy, and will prove an invaluable resource for scholars, teachers, and advanced students.

This article examines the implicit promises of fairness in evidence based medicine , namely to avoid discrimination through objective processes, and to distribute effective treatments fairly. The relationship between EBM and vulnerable groups is examined. Several aspects of EBM are explored: the way evidence is created , and the way evidence is applied in clinical care and health policy. This analysis suggests that EBM turns our attention away from social and cultural factors that influence health and focuses on a narrow biomedical and individualistic model of health. Those with the greatest burden of ill health are left disenfranchised, as there is little research that is relevant to them, there is poor access to treatments, and attention is diverted away from activities that might have a much greater impact on their health

Bioethics is a practically oriented discipline that developed to address pressing ethical issues arising from developments in the life sciences. Given this inherent practical bent, some form of advocacy or activism seems inherent to the nature of bioethics. However, there are potential tensions between being a bioethics activist, and academic ideals. In academic bioethics, scholarship involves reflection, rigour and the embrace of complexity and uncertainty. These values of scholarship seem to be in tension with being an activist, which requires pragmatism, simplicity, certainty and, above all, action. In this paper I explore this apparent dichotomy, using the case example of my own involvement in international efforts to end forced organ harvesting from prisoners of conscience in China. I conclude that these tensions can be managed and that academic bioethics requires a willingness to be activist.

OBJECTIVES: To study and report the attitudes of patients and general practitioners (GPs) concerning the obligation of doctors to act for the good of their patients, and to provide a practical account of beneficence in general practice. DESIGN: Semi-structured interviews administered to GPs and patients. SETTING AND SAMPLE: Participants randomly recruited from an age and gender stratified list of GPs in a geographically defined region of South Australia. The sample comprised twenty-one general practitioners and seventeen patients recruited by participating GPs. RESULTS: In practice, acting for the good of the patient not only accommodates the views of patients and GPs on expertise and knowing best, but also responds to the particular details of the clinical situation. Patients had a complex understanding of the expertise necessary for medical practice, describing a contextual domain in which they were expert, and which complemented the scientific expertise of their GPs. General practitioners identified multiple sources for their expertise, of which experience was the most significant. The role of the GP included responding to individual patients and particular clinical problems and ranged from the assumption of responsibility through to the proffering of medical advice. CONCLUSION: This study found that GPs acting for the good of their patients covered a variety of GP actions and patient preferences. Beneficence was not justified by presumed patient vulnerability or the inability of patients to understand medical problems, but furthered through a recognition of the different areas of expertise contributed by both parties to the consultation

Throughout March and April 2020, debate raged about how best to allocate limited intensive care unit resources in the face of a growing COVID-19 pandemic. The debate was dominated by utility-based arguments for saving the most lives or life-years. These arguments were tempered by equity-based concerns that triage based solely on prognosis would exacerbate existing health inequities, leaving disadvantaged patients worse off. Central to this debate was the assumption that ICU admission is a valuable but scarce resource in the pandemic context.In this paper, we argue that the concern about achieving equity in ICU triage is problematic for two reasons. First, ICU can be futile and prolong or exacerbate suffering rather than ameliorate it. This may be especially true in patients with COVID-19 with emerging data showing that most who receive access to a ventilator will still die. There is no value in admitting patients with poor prognostic indicators to ICU to meet an equity target when intensive critical care is contrary to their best interests. Second, the focus on ICU admission shifts focus away from important aspects of COVID-19 care where there is greater opportunity for mitigating suffering and enhancing equitable care.We propose that the focus on equity concerns during the pandemic should broaden to include providing all people who need it with access to the highest possible standard of end-of-life care. This requires attention to culturally safe care in the following interlinked areas: palliative care, communication and decision support and advanced care planning.

Despite concerns about the relationships between health professionals and the medical device industry, the issue has received relatively little attention. Prevalence data are lacking; however, qualitative and survey research suggest device industry representatives, who are commonly present in clinical settings, play a key role in these relationships. Representatives, who are technical product specialists and not necessarily medically trained, may attend surgeries on a daily basis and be available to health professionals 24 hours a day, 7 days a week, to provide advice. However, device representatives have a dual role: functioning as commissioned sales representatives at the same time as providing advice on approaches to treatment. This duality raises the concern that clinical decision-making may be unduly influenced by commercial imperatives. In this paper, we identify three key ethical concerns raised by the relationship between device representatives and health professionals: impacts on healthcare costs, the outsourcing of expertise and issues of accountability and informed consent. These ethical concerns can be addressed in part through clarifying the boundary between the support and sales aspects of the roles of device representatives and developing clear guidelines for device representatives providing support in clinical spaces. We suggest several policy options including hospital provision of expert support, formalising clinician conduct to eschew receipt of meals and payments from industry and establishing device registries.

This paper draws attention to gendered dimensions of surgical device failure, focusing on two case studies—hernia repair mesh for pelvic organ prolapse, and metal-on-metal hip implants. We explore possible reasons for higher rates of harms to women, including systematic biases in health research and device regulation. Given that these factors are readily identifiable, we look to feminist scholarship to understand what might maintain them, including the role of cultural factors within surgery, such as gendered communication patterns and sexism. We then canvas potential measures to mitigate the increased risk of harms faced by women who use implanted devices.

In this paper we consider the use of cases in medical ethics research and teaching. To date, there has been little discussion about the consent or confidentiality requirements that ought to govern the use of cases in these areas. This is in marked contrast to the requirements for consent to publish cases in clinical journals, or to use personal information in research. There are a number of reasons why it might be difficult to obtain consent to use cases in ethics. Many cases concern people who are incompetent, and thus unable to give consent. Often the material is of a sensitive nature, it is not clear who should give consent, or the ethicist has no access to those involved. We argue that the use of cases in ethics research and teaching can be justified by appeal to the public interest argument, and suggest a number of areas for discussion and clarification

Placebo-controlled surgical trials can provide important information about the efficacy of surgical interventions. However, they are ethically contentious as placebo surgery entails the risk of harms to recipients, such as pain, scarring or anaesthetic misadventure. This has led to claims that placebo-controlled surgical trials are inherently unethical. On the other hand, without placebo-controlled surgical trials, it may be impossible to know whether an apparent benefit from surgery is due to the intervention itself or to the placebo effect

The development and deployment of medical devices, along with most areas of healthcare, has been significantly impacted by the COVID-19 pandemic. This has had variable ethical implications, two of which we will focus on here. First, medical device regulations have been rapidly amended to expedite approvals of devices ranging from face masks to ventilators. Although some regulators have issued cessation dates, there is inadequate discussion of triggers for exiting these crisis standards, and evidence that this may not be feasible. Given the relatively low evidence standards currently required for regulatory approval of devices, this further indefinite reduction in standards raises serious ethical issues. Second, the pandemic has disrupted the usual operations of device representatives in hospitals, providing an opportunity to examine and refine this potentially ethically problematic practice. In this paper we explain and critically analyse the ethical implications of these two pandemic-related impacts on medical devices and propose suggestions for their management. These include an endpoint for pandemic-related adjustments to device regulation or a mechanism for continued refinement over time, together with a review of device research conducted under crisis conditions, support for the removal and replacement of emergency approved devices, and a review of device representative credentialling.

Recent calls for retraction of a large body of Chinese transplant research and of Dr Jiankui He’s gene editing research has led to renewed interest in the question of publication, retraction and use of unethical biomedical research. In Part 1 of this paper, we briefly review the now well-established consequentialist and deontological arguments for and against the use of unethical research. We argue that, while there are potentially compelling justifications for use under some circumstances, these justifications fail when unethical practices are ongoing—as in the case of research involving transplantations in which organs have been procured unethically from executed prisoners. Use of such research displays a lack of respect and concern for the victims and undermines efforts to deter unethical practices. Such use also creates moral taint and renders those who use the research complicit in continuing harm. In Part 2, we distinguish three dimensions of ‘non-use’ of unethical research: non-use of published unethical research, non-publication, and retraction and argue that all three types of non-use should be upheld in the case of Chinese transplant research. Publishers have responsibilities to not publish contemporary unethical biomedical research, and where this has occurred, to retract publications. Failure to retract the papers implicitly condones the research, while uptake of the research through citations rewards researchers and ongoing circulation of the data in the literature facilitates subsequent use by researchers, policymakers and clinicians.

Our motivation for proposing a special issue of IJFAB on vulnerability is twofold. First, there is growing interest in the concept of vulnerability within both bioethics and feminist theory. Reflecting this interest, this special issue provides a forum for exploring the relevance for bioethics of feminist perspectives on vulnerability. Second, despite growing recognition within bioethics of the moral significance of vulnerability, the concept remains under-theorized in bioethical (and wider philosophical) discourse. Questions that are central to current debates but that require further theoretical analysis include the following: What is vulnerability and what are the sources of vulnerability? What duties are owed ..

Public health plays an important, albeit often unnoticed, role in protecting and promoting the health of populations. The activities of public health are complex, performed by multiple professionals, and range from the innocuous to the intrusive. Ethical analyses in public health reflect some of this complexity and fragmentation, with no one approach able to capture the full range of ethical considerations raised by public health activities. There are however, good reasons why we should pursue such analyses. Providing a robust ethical framework for public health may promote the identity and function of public health, address some of the shortcomings of utilitarianism, and help to combat the threat that public health faces through lack of political will in many parts of the world.In this paper I argue that Alasdair MacIntyre’s account of practices and virtues can make a valuable contribution to public health ethics. The first part of the paper argues that public health may properly be described as the type of practice that provides an arena for the exercise of virtues. This is followed by an analysis of the three virtues of honesty, courage and justice in public health practice. Using virtue theory captures morally important elements of public health and helps to maintain awareness of significant moral values in the practice of public health. Such awareness is crucial in maintaining and defending the integrity of public health.

We agree with Faunce’s proposal that academic legitimacy is important in ensuring that whistle-blowing is included in medical curricula. We disagree, however, with the assertion that this is best achieved by means of an over-arching theoretical foundation for health care whistle-blowing of the kind suggested by Faunce. We propose that systematic theoretical justification is neither the sole nor the main determinant of academic legitimacy when it comes to matters for inclusion in medical school curricula, and outline an alternative view, together with a practical example of a healthcare whistle-blowing topic.

Since the 1990s, glycated haemoglobin (HbA1C) has been the gold standard for monitoring glycaemic control in people diagnosed as having either type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM). Discussions are underway about diagnosing diabetes mellitus on the basis of HbA1C titres and using HbA1C tests to screen for T2DM. These discussions have focused on the relative benefits for individual patients, with some attention directed towards reduced costs to healthcare systems and benefits to society. We argue that there are strong ethical reasons for adopting HbA1C-based diagnosis and T2DM screening that have not yet been articulated. The rationale includes the differential impact of HbA1C-based diabetic testing on disadvantaged groups, and what we are beginning to learn about HbA1C vis-à-vis population health. Although it is arguable that screening must primarily benefit the individual, using HbA1C to diagnose and screen for T2DM may promote a more just distribution of health resources and lead to advances in investigating, monitoring and tackling the social determinants of health

Recently, concerns have been raised about the phenomenon of 'overdiagnosis', the diagnosis of a condition that is not causing harm, and will not come to cause harm. Along with practical, ethical, and scientific questions, overdiagnosis raises questions about our concept of disease. In this paper, we analyse overdiagnosis as an epistemic problem and show how it challenges many existing accounts of disease. In particular, it raises questions about conceptual links drawn between disease and dysfunction, harm, and risk. We argue that "disease" should be considered a vague concept with a nonclassical structure. On this view, overdiagnosed cases are 'borderline' cases of disease, falling in the zone between cases that are clearly disease, and cases that are clearly not disease. We then develop a précising definition of disease designed to provide practical help in preventing and limiting overdiagnosis. We argue that for this purpose, we can define disease as dysfunction that has a significant risk of causing severe harm to the patient.