High-dose chemotherapy and autologous stem cell transplantation is used to treat some advanced malignancies. It is a traumatic procedure, with a high complication rate and significant mortality. ASCT patients and their carers draw on many sources of information as they seek to understand the procedure and its consequences. Some seek information from beyond orthodox medicine. Alternative beliefs and practices may conflict with conventional understanding of the theory and practice of ASCT, and ‘contested understandings’ might interfere with patient adherence to the (...) strict and demanding protocols required for successful ASCT.The present study, conducted in Sydney, Australia, examines narrative-style interviews with 10 sequentially recruited ASCT patients and nine of their carers conducted at the time of transplant and three months later. Transcripts were read for instances of mention of alternative advice, and for instances of contested understanding of information relevant to the transplant.Patients and carer pairs expressed closely concordant views about alternative advice. Five pairs were consulting alternative practitioners. Contested understanding was expressed in four domains—understandings of the transplant itself and its underlying theory, of the relationship between the components of the ‘transplant’, of the nature and role of stem cells, and of beliefs about bodily function and life-style. Contested understandings of the transplant treatment were expressed as predominantly personal interpretations of orthodox informationPatients and carers seemed to recognise that alternative and conventional systems were discordant, yet they were able to separate the two, and adhere to each practice without prejudicing their medical treatment. A single case of late, post-transplant repudiation of Western medicine is discussed to emphasise some of the possible determinants of dissonance when it does occur. (shrink)

Scheinerman (2023) proposes that at the Human Genome Editing Initiative international summit (held in March 2023) there should have been a parallel, separate Citizens’ Jury, and that the Human Geno...

Overdiagnosis is an emerging problem in health policy and practice: we address its definition and ethical implications. We argue that the definition of overdiagnosis should be expressed at the level of populations. Consider a condition prevalent in a population, customarily labelled with diagnosis A. We propose that overdiagnosis is occurring in respect of that condition in that population when the condition is being identified and labelled with diagnosis A in that population ; this identification and labelling would be accepted as (...) correct in a relevant professional community; but the resulting label and/or intervention carries an unfavourable balance between benefits and harms. We identify challenges in determining and weighting relevant harms, then propose three central ethical considerations in overdiagnosis: the extent of harm done, whether harm is avoidable and whether the primary goal of the actor/s concerned is to benefit themselves or the patient, citizen or society. This distinguishes predatory, misdirected and tragic overdiagnosis; the degree of harm moderates the justifiability of each type. We end with four normative challenges: methods for adjudicating between professional standards and identifying relevant harms and benefits should be procedurally just; individuals, organisations and states are differently responsible for addressing overdiagnosis; overdiagnosis is a matter for distributive justice: the burdens of both overdiagnosis and its prevention could fall on the least-well-off; and communicating about overdiagnosis risks harming those unaware that they may have been overdiagnosed. These challenges will need to be addressed as the field develops. (shrink)

The empirical turn in bioethics and the deliberative turn in democracy theory occurred at around the same time, one at the intersection of bioethics and social science,1 2 the other at the intersection of political philosophy and political science.3–5 Empirical bioethics and deliberative democratic approaches both engage with immediate problems in policy and practice with normative intent, so it was perhaps inevitable that they would eventually find one another,6–8 and that deliberative research would become more common in bioethics.9 This commentary (...) responds to a paper by Ford et al, who ran a single jury of 18 people in Brighton in the UK in June 2018.10 The jury were asked to consider whether secondary research use of non-structured, free-text data from medical records should be permitted. I will consider three issues: the effort required in deliberative work, the challenge of sampling and selection of jurors and the basis for drawing normative conclusions from deliberative research. First: this report makes clear the effort involved in running a jury. These researchers contracted an external agency experienced in the method, established an oversight committee of policy-makers with power to act, developed expert witness briefs, selected witnesses and coordinated their testimony, and created a questionnaire to measure participants’ views, activities to support their understanding, and a scenario for consideration. …. (shrink)

Bioethics, Volume 35, Issue 7, Page 623-633, September 2021.

This article provides a critical comparative analysis of the substantive and procedural values and ethical concepts articulated in guidelines for allocating scarce resources in the COVID-19 pandemic. We identified 21 local and national guidelines written in English, Spanish, German and French; applicable to specific and identifiable jurisdictions; and providing guidance to clinicians for decision making when allocating critical care resources during the COVID-19 pandemic. US guidelines were not included, as these had recently been reviewed elsewhere. Information was extracted from each (...) guideline on: 1) the development process; 2) the presence and nature of ethical, medical and social criteria for allocating critical care resources; and 3) the membership of and decision-making procedure of any triage committees. Results of our analysis show the majority appealed primarily to consequentialist reasoning in making allocation decisions, tempered by a largely pluralistic approach to other substantive and procedural values and ethical concepts. Medical and social criteria included medical need, co-morbidities, prognosis, age, disability and other factors, with a focus on seemingly objective medical criteria. There was little or no guidance on how to reconcile competing criteria, and little attention to internal contradictions within individual guidelines. Our analysis reveals the challenges in developing sound ethical guidance for allocating scarce medical resources, highlighting problems in operationalising ethical concepts and principles, divergence between guidelines, unresolved contradictions within the same guideline, and use of naïve objectivism in employing widely used medical criteria for allocating ICU resources. (shrink)

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. (shrink)

Background Outbreaks of infectious disease cause serious and costly health and social problems. Two new technologies – pathogen whole genome sequencing and Big Data analytics – promise to improve our capacity to detect and control outbreaks earlier, saving lives and resources. However, routinely using these technologies to capture more detailed and specific personal information could be perceived as intrusive and a threat to privacy. Method Four community juries were convened in two demographically different Sydney municipalities and two regional cities in (...) New South Wales, Australia to elicit the views of well-informed community members on the acceptability and legitimacy of: making pathogen WGS and linked administrative data available for public health researchusing this information in concert with data linkage and machine learning to enhance communicable disease surveillance systems Fifty participants of diverse backgrounds, mixed genders and ages were recruited by random-digit-dialling and topic-blinded social-media advertising. Each jury was presented with balanced factual evidence supporting different expert perspectives on the potential benefits and costs of technologically enhanced public health research and communicable disease surveillance and given the opportunity to question experts. Results Almost all jurors supported data linkage and WGS on routinely collected patient isolates for the purposes of public health research, provided standard de-identification practices were applied. However, allowing this information to be operationalised as a syndromic surveillance system was highly contentious with three juries voting in favour, and one against by narrow margins. For those in favour, support depended on several conditions related to system oversight and security being met. Those against were concerned about loss of privacy and did not trust Australian governments to run secure and effective systems. Conclusions Participants across all four events strongly supported the introduction of data linkage and pathogenomics to public health research under current research governance structures. Combining pathogen WGS with event-based data surveillance systems, however, is likely to be controversial because of a lack of public trust, even when the potential public health benefits are clear. Any suggestion of private sector involvement or commercialisation of WGS or surveillance data was unanimously rejected. (shrink)

This article draws on an empirical investigation of how Australia’s cervical screening program came to be the way it is. The study was carried out using grounded theory methodology and primarily uses interviews with experts involved in establishing, updating or administering the program. We found strong differences in experts’ normative evaluations of the program and beliefs about optimal ways of achieving the same basic outcome: a reduction in morbidity and mortality caused by invasive cervical cancer. Our analysis demonstrates how variations (...) in values and preferences associated with key concepts underpinning public health such as benefit, harm and burden led to different perspectives on the purpose of an organized cervical screening program. These variations were largely driven by different bases of professional experience. Differently conceived purposes in turn led to conflict over how the program should be operationalized. Following Frith’s model of empirical bioethics, the results of the study both draw on and inform the existing public health and screening ethics literature. (shrink)

I argue that greater attention to human agency and normativity in both researching and practicing service improvement may be one strategy for enhancing improvement science, illustrating with examples from cancer screening. Improvement science tends to deliberately avoid explicit normativity, for paradigmatically coherent reasons. But there are good reasons to consider including explicit normativity in thinking about improvement. Values and moral judgements are central to social life, so an adequate account of social life must include these elements. And improvement itself is (...) unavoidably normative: it assumes that things could and should be better than they are. I seek to show that normativity will always be implicated in the creation of evidence, the design of programs, the practice of healthcare, and in citizens’ judgements about that care, and to make a case that engaging with this normativity is worthwhile. (shrink)

Evidence-Based Medicine (EBM) has now been part of the dominant medical paradigm for 15 years, and has been frequently debated and progressively modified. One question about EBM that has not yet been considered systematically, and is now particularly timely, is the question of the novelty, or otherwise, of the principles and practices of EBM. We argue that answering this question, and the related question of whether EBM-type principles and practices are unique to medicine, sheds new light on EBM and has (...) practical implications for those involved in all EBM. This is because one's answer to the question (whether explicit or implicit) affects the amount and type of funding and attention received by EBM, the extent to which EBM, and the generation, judgment and use of evidence more generally, can be appropriated by certain groups and questioned by others, and the extent to which truly unique socio-political developments in evidence, and in medicine more generally, are recognized and harnessed. (shrink)

This article provides a commentary on Standards of practice in empirical bioethics research by Ives and colleagues. There is much to admire in the paper, and in the demanding consensus-building process on which it reports. I discuss the problems and limits of methodological standardisation, and a central conceptual tension that appears to have divided participants. I suggest that the finished product should be understood as a record of a methodological conversation, rather than being used as a disciplinary tool to limit (...) the evolution of empirical bioethics. (shrink)

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. (shrink)

The American Journal of Bioethics, Volume 11, Issue 7, Page 57-59, July 2011.

Peer review of manuscripts for biomedical journals has become a subject of intense ethical debate. One of the most contentious issues is whether or not peer review should be anonymous. This study aimed to generate a rich, empirically-grounded understanding of the values held by journal editors and peer reviewers with a view to informing journal policy. Qualitative methods were used to carry out an inductive analysis of biomedical reviewers’ and editors’ values. Data was derived from in-depth, open-ended interviews with journal (...) editors and peer reviewers. Data was “read for” themes relevant to reviewer anonymisation and interactions among editors, reviewers, and authors. Editors and peer reviewers provided three arguments that would support a more open and interactive peer-review process. First, a number of participants emphasised the importance of not only ensuring the scientific quality of published research but also nurturing their colleagues and supporting their communities. Second, many spoke about the ongoing moral responsibilities that reviewers and editors felt toward authors. Finally, participants spoke at length about their enjoyment of social interactions and of the value of collective, rather than isolated, reasoning processes. Whether or not journal editors decide to allow anonymous review , the values of editors and reviewers need to be seriously addressed in codes of publication ethics, in the management of biomedical journals, and in the establishment of journal policies. (shrink)

It is not clear whether breast cancer screening is a public health intervention or an individual clinical service. The question is important because the concepts best suited for ethical reasoning in public health might be different to the concepts commonly employed in biomedical ethics. We consider it likely that breast screening has elements of a public health intervention and used an empirical ethics approach to explore this further. If breast screening has public health characteristics, it is probable that policy and (...) practice experts will employ socially embedded concepts when reasoning about it. We gathered data on whether and how these concepts existed in the discussion and reasoning of Australian breast screening experts. We found that experts employed these concepts when talking about the purpose and practices of breast screening, and the behaviour of breast screening professionals and consumers. Experts gave varied judgements about breast screening based on reasoning with these concepts, considering it to be more or less successful in contributing to the public interest and in incorporating socially embedded concepts into its operational agenda. Our findings are compatible with breast screening having public health characteristics. We advocate for the incorporation of socially embedded concepts in breast screening policy and practice. (shrink)

Background Parental refusal of routine childhood vaccination remains an ethically contested area. This systematic review sought to explore and characterise the normative arguments made about parental refusal of routine vaccination, with the aim of providing researchers, practitioners, and policymakers with a synthesis of current normative literature. Methods Nine databases covering health and ethics research were searched, and 121 publications identified for the period Jan 1998 to Mar 2022. For articles, source journals were categorised according to Australian Standard Field of Research (...) codes, and normative content was analysed using a framework analytical approach. Results Most of the articles were published in biomedical journals (34%), bioethics journals (21%), and journals that carry both classifications (20%). Two central questions dominated the literature: (1) Whether vaccine refusal is justifiable (which we labelled ‘refusal arguments’); and (2) Whether strategies for dealing with those who reject vaccines are justifiable (‘response arguments’). Refusal arguments relied on principlism, religious frameworks, the rights and obligations of parents, the rights of children, the medico-legal best interests of the child standard, and the potential to cause harm to others. Response arguments were broadly divided into arguments about policy, arguments about how individual physicians should practice regarding vaccine rejectors, and both legal precedents and ethical arguments for vaccinating children against a parent’s will. Policy arguments considered the normative significance of coercion, non-medical or conscientious objections, and possible reciprocal social efforts to offset vaccine refusal. Individual physician practice arguments covered nudging and coercive practices, patient dismissal, and the ethical and professional obligations of physicians. Most of the legal precedents discussed were from the American setting, with some from the United Kingdom. Conclusions This review provides a comprehensive picture of the scope and substance of normative arguments about vaccine refusal and responses to vaccine refusal. It can serve as a platform for future research to extend the current normative literature, better understand the role of cultural context in normative judgements about vaccination, and more comprehensively translate the nuance of ethical arguments into practice and policy. (shrink)

Precision medicine is an emerging approach to treatment and disease prevention that relies on linkages between very large datasets of health information that is shared amongst researchers and health professionals. While studies suggest broad support for sharing precision medicine data with researchers at publicly funded institutions, there is reluctance to share health information with private industry for research and development. As the private sector is likely to play an important role in generating public benefits from precision medicine initiatives, it is (...) important to understand what the concerns are and how they might be mitigated. This study reports outcomes of a deliberative method of citizen engagement in Singapore that asked whether sharing precision medicine data with private industry would be permissible, and if so, under what circumstances. Findings from this citizens’ jury suggest sharing with industry would be permissible under certain conditions that are set out in nine recommendations. Implications of the recommendations and their underlying assumptions for policy decision makers are discussed. This study aligns with prior international studies which found conditional acceptance for data sharing with private industry, a public benefit requirement, specific reluctance to share with insurance companies and an emphasis on accountability and transparency to demonstrate trustworthiness. However, our results differ from prior studies in that opt-in consent did not dominate the deliberations as jurors were able to set it aside as an assumed prerequisite for participation in a precision medicine programme. (shrink)

In this commentary, I explore the ethically relevant dimensions of menu labelling. The evidence that menu labelling changes purchasing or consumption behaviour is contentious and inconclusive; there is some suggestion that menu labelling may preferentially influence the behaviour of healthier and wealthier citizens. Some suggest that menu labelling is unjust, as it fails to direct resources towards those who most need them. An alternative is to see menu labels as just one of a set of strategies that can increase people’s (...) real opportunities to be healthy. Complementing strategies will be necessary to ensure that all citizens can consider and value food choices, which may include becoming a more critical consumer in the food marketplace. Menu labels may also have the potential to shift our attention from people to food, reallocate responsibility in the food environment and facilitate structural change. It would be a mistake to expect too much of menu labels alone: rather, they should be integrated into a broader programme that supports health opportunities, especially for the least well off. (shrink)

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. (shrink)

Bioethics, Volume 36, Issue 6, Page 728-730, July 2022.

BackgroundCervical cancer disproportionately burdens disadvantaged women. Organised cervical screening aims to make cancer prevention available to all women in a population, yet screening uptake and cancer incidence and mortality are strongly correlated with socioeconomic status. Reaching underscreened populations is a stated priority in many screening programs, usually with an emphasis on something like ‘equity’. Equity is a poorly defined and understood concept. We aimed to explain experts’ perspectives on how cervical screening programs might justifiably respond to ‘the underscreened’.MethodsThis paper reports (...) on a grounded theory study of cervical screening experts involved in program organisation. Participants were 23 experts from several countries and a range of backgrounds: gynecology; epidemiology; public health; pathology; general practice; policy making. Data were gathered via semi-structured interview and concepts developed through transcript coding and memo writing.ResultsMost experts expressed an intuitive commitment to reducing systematic differences in screening participation or cancer outcomes. They took three different implicit positions, however, on what made organised programs justifiable with respect to underscreened populations. These were: 1) accepting that population screening is likely to miss certain disenfranchised groups for practical and cultural reasons, and focusing on maximising mainstream reach; 2) identifying and removing barriers to screening; and 3) providing parallel tailored screening services that attended to different cultural needs. Positions tended to fall along country of practice lines.ConclusionsExperts emphasised the provision of opportunity for underscreened populations to take up screening. A focus on opportunity appeared to rely on tacit premises not supported by evidence: that provision of meaningful opportunity leads to increased uptake, and that increased uptake of an initial screening test by disadvantaged populations would decrease cervical cancer incidence and mortality. There was little attention to anything other than the point of testing, or the difficulties disadvantaged women can have in accessing follow up care. The different approaches to ‘improving equity’ taken by participants are differently justified, and differently justifiable, but none attend directly to the broader conditions of disadvantage. (shrink)