Despite the increased prevalence of bioethics research that seeks to use empirical data to answer normative research questions, there is no consensus as to what an appropriate methodology for this would be. This review aims to search the literature, present and critically discuss published Empirical Bioethics methodologies.

This paper responds to the commentaries from Stacy Carter and Alan Cribb. We pick up on two main themes in our response. First, we reflect on how the process of setting standards for empirical bioethics research entails drawing boundaries around what research counts as empirical bioethics research, and we discuss whether the standards agreed in the consensus process draw these boundaries correctly. Second, we expand on the discussion in the original paper of the role and significance of the concept of (...) ‘integrating’ empirical methods and ethical argument as a standard for research practice within empirical bioethics. (shrink)

Realizing the benefits of translating psychiatric genomics research into mental health care is not straightforward. The translation process gives rise to ethical challenges that are distinctive from challenges posed within psychiatric genomics research itself, or that form part of the delivery of clinical psychiatric genetics services. This article outlines and considers three distinct ethical concerns posed by the process of translating genomic research into frontline psychiatric practice and policy making. First, the genetic essentialism that is commonly associated with the genomics (...) revolution in health care might inadvertently exacerbate stigma towards people with mental disorders. Secondly, the promises of genomic medicine advance a narrative of individual empowerment. This narrative could promote a fatalism towards patients' biology in ways that function in practice to undermine patients' agency and autonomy, or, alternatively, a heightened sense of subjective genetic responsibility could become embedded within mental health services that leads to psychosocial therapeutic approaches and the clinician-patient therapeutic alliance being undermined. Finally, adopting a genomics-focused approach to public mental health risks shifting attention away from the complex causal relationships between inequitable socio-economic, political, and cultural structures and negative mental health outcomes. The article concludes by outlining a number of potential pathways for future ethics research that emphasizes the importance of examining appropriate translation mechanisms, the complementarity between genetic and psychosocial models of mental disorder, the implications of genomic information for the clinician-patient relationship, and funding priorities and resource allocation decision making in mental health. (shrink)

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

As the COVID-19 pandemic impacts on health service delivery, health providers are modifying care pathways and staffing models in ways that require health professionals to be reallocated to work in critical care settings. Many of the roles that staff are being allocated to in the intensive care unit and emergency department pose additional risks to themselves, and new policies for staff reallocation are causing distress and uncertainty to the professionals concerned. In this paper, we analyse a range of ethical issues (...) associated with changes to staff allocation processes in the face of COVID-19. In line with a dominant view in the medical ethics literature, we claim, first, that no individual health professional has a specific, positive obligation to treat a patient when doing so places that professional at risk of harm, and so there is a clear ethical tension in any reallocation process in this context. Next, we argue that the changing asymmetries of health needs in hospitals means that careful consideration needs to be given to a stepwise process for deallocating staff from their usual duties. We conclude by considering how a justifiable process of reallocating professionals to high-risk clinical roles should be configured once those who are ‘fit for reallocation’ have been identified. We claim that this process needs to attend to three questions that we consider in detail: how the choice to make reallocation decisions is made, what justifiable models for reallocation might look like and what is owed to those who are reallocated. (shrink)

In this paper we set forth what we believe to be a relatively controversial argument, claiming that 'bioethics' needs to undergo a fundamental change in the way it is practised. This change, we argue, requires philosophical bioethicists to adopt reflexive practices when applying their analyses in public forums, acknowledging openly that bioethics is an embedded socio-cultural practice, shaped by the ever-changing intuitions of individual philosophers, which cannot be viewed as a detached intellectual endeavour. This said, we argue that in order (...) to manage the personal, social and cultural embeddedness of bioethics, philosophical bioethicists should openly acknowledge how their practices are constructed and should, in their writing, explicitly deal with issues of bias and conflict of interest, just as empirical scientists are required to do. (shrink)

There is a growing body of literature that has sought to undermine systems of ethical regulation, and governance more generally, within the social sciences. In this paper, we argue that any general claim for a system of research ethics governance in social research depends on clarifying the nature of the stake that society has in research. We show that certain accounts of this stake—protecting researchers’ freedoms; ensuring accountability for resources; safeguarding welfare; and supporting democracy—raise relevant ethical considerations that are reasonably (...) contested. However, these accounts cannot underpin a general claim in favour of, or against, a system of research ethics governance. Instead, we defend governance in social research on the grounds that research, as an institutionalised form of enquiry, is a constitutive element of human flourishing, and that society ought to be concerned with the flourishing of its members. We conclude by considering the governance arrangements that follow from, and are justified by, our arguments. (shrink)

The law of informed consent to medical treatment has recently been extensively overhauled in England. The 2015 Montgomery judgment has done away with the long-held position that the information to be disclosed by doctors when obtaining valid consent from patients should be determined on the basis of what a reasonable body of medical opinion agree ought to be disclosed in the circumstances. The UK Supreme Court concluded that the information that is material to a patient’s decision should instead be judged (...) by reference to a new two-limbed test founded on the notions of the ‘reasonable person’ and the ‘particular patient’. The rationale outlined in Montgomery for this new test of materiality, and academic comment on the ruling’s significance, has focused on the central ethical importance that the law now accords to respect for patient autonomy in the process of obtaining consent from patients. In this paper, we dispute the claim that the new test of materiality articulated in Montgomery equates with respect for autonomy being given primacy in re-shaping the development of the law in this area. We also defend this position, arguing that our revised interpretation of Montgomery’s significance does not equate with a failure by the courts to give due legal consideration to what is owed to patients as autonomous decision-makers in the consent process. Instead, Montgomery correctly implies that doctors are ethically obliged to attend to a number of relevant ethical considerations in framing decisions about consent to treatment, which include subtle interpretations of the values of autonomy and well-being. Doctors should give appropriate consideration to how these values are fleshed out and balanced in context in order to specify precisely what information ought to be disclosed to a patient as a requirement of obtaining consent, and as a core component of shared decision-making within medical encounters more generally. (shrink)

Population-level biomedical research offers new opportunities to improve population health, but also raises new challenges to traditional systems of research governance and ethical oversight. Partly in response to these challenges, various models of public involvement in research are being introduced. Yet, the ways in which public involvement should meet governance challenges are not well understood. We conducted a qualitative study with 36 experts and stakeholders using the World Café method to identify key governance challenges and explore how public involvement can (...) meet these challenges. This brief report discusses four cross-cutting themes from the study: the need to move beyond individual consent; issues in benefit and data sharing; the challenge of delineating and understanding publics; and the goal of clarifying justifications for public involvement. The report aims to provide a starting point for making sense of the relationship between public involvement and the governance of population-level biomedical research, showing connections, potential solutions and issues arising at their intersection. We suggest that, in population-level biomedical research, there is a pressing need for a shift away from conventional governance frameworks focused on the individual and towards a focus on collectives, as well as to foreground ethical issues around social justice and develop ways to address cultural diversity, value pluralism and competing stakeholder interests. There are many unresolved questions around how this shift could be realised, but these unresolved questions should form the basis for developing justificatory accounts and frameworks for suitable collective models of public involvement in population-level biomedical research governance. No data are available. (shrink)

Biomedical research funding bodies across Europe and North America increasingly encourage—and, in some cases, require—investigators to involve members of the public in funded research. Yet there remains a striking lack of clarity about what ‘good’ or ‘successful’ public involvement looks like. In an effort to provide guidance to investigators and research organisations, representatives of several key research funding bodies in the UK recently came together to develop the National Standards for Public Involvement in Research. The Standards have critical implications for (...) the future of biomedical research in the UK and in other countries as researchers and funders abroad look to the Standards as a model for their own policy development. We assess the Standards and find that despite offering useful suggestions for dealing with practical challenges associated with public involvement, the Standards fail to address fundamental questions about when, why and with whom public involvement should be undertaken in the first place. We show that presented without this justificatory context, many of the recommendations in the Standards are, at best, fragments that require substantial elaboration by those looking to apply the Standards in their own work and, at worst, subject to potentially harmful misapplication by well-meaning investigators. As funding bodies increasingly push for public involvement in research, the key lesson of our analysis is that future recommendations about how public involvement should be conducted cannot be coherently formulated without a clear sense of the underlying goals and rationales for public involvement. (shrink)

Population-level biomedical research has become crucial to the health system’s ability to improve the health of the population. This form of research raises a number of well-documented ethical concerns, perhaps the most significant of which is the inability of the researcher to obtain fully informed specific consent from participants. Two proposed technical solutions to this problem of consent in large-scale biomedical research that have become increasingly popular are meta-consent and dynamic consent. We critically examine the ethical and practical credentials of (...) these proposals and find them lacking. We suggest that the consent problem is not solved by adopting a technology driven approach grounded in a notion of ‘specific’ consent but by taking seriously the role of research governance in combination with broader conceptions of consent. In our view, these approaches misconstrue the rightful location of authority in the way in which population-level biomedical research activities are structured and organized. We conclude by showing how and why the authority for determining the nature and shape of choice making about participation ought not to lie with individual participants, but rather with the researchers and the research governance process, and that this necessarily leads to the endorsement of a fully articulated broad consent approach. (shrink)

Much has been written in the last decade about how we should understand the value of the sociology of bioethics. Increasingly the value of the sociology of bioethics is interpreted by its advocates directly in terms of its relationship to bioethics. It is claimed that the sociology of bioethics (and related disciplinary approaches) should be seen as an important component of work in bioethics. In this paper we wish to examine whether, and how, the sociology of bioethics can be defended (...) as a valid and justified research activity, in the context of debates about the nature of bioethics. We begin by presenting and arguing for an account of bioethics that does justice to the content of the field, the range of questions that belong within this field, and the justificatory standards (and methodological orientations) that can provide convincing answers to these questions. We then consider the role of sociology in bioethics and show how and under what conditions it can contribute to answering questions within bioethics. In the final section, we return to the sociology of bioethics to show that it can make only a limited contribution to the field. (shrink)

Discussion of real cases encountered by medical students has been advocated as a component of medical ethics education. Suggested benefits include: a focus on the actual problems that medical students confront; active learner involvement; and facilitation of an exploration of the meaning of their own values in relation to professional behaviour. However, the approach may also carry risks: students may focus too narrowly on particular clinical topics or show a preference for discussing legal problems that may appear to have clearer (...) solutions. Teaching may therefore omit areas generally considered to be important components of the curriculum. In this paper, the authors present an analysis of the moral problems raised by medical students in response to a request to describe ethically problematic cases they had encountered during two clinical attachments, for the purpose of educational discussion at case-based seminars. We discuss the problems raised and compare the content of the cases to the UK Consensus Statement on core content of learning. The authors also describe the approaches that the students used to undertake an initial analysis of the problems raised, and consider possible implications for the development of medical ethics education. (shrink)

The COVID-19 pandemic crisis has necessitated widespread adaptation of revised treatment regimens for both urgent and routine medical problems in patients with and without COVID-19. Some of these alternative treatments maybe second-best. Treatments that are known to be superior might not be appropriate to deliver during a pandemic when consideration must be given to distributive justice and protection of patients and their medical teams as well the importance given to individual benefit and autonomy. What is required of the doctor discussing (...) these alternative, potentially inferior treatments and seeking consent to proceed? Should doctors share information about unavailable but standard treatment alternatives when seeking consent? There are arguments in defence of non-disclosure; information about unavailable treatments may not aid a patient to weigh up options that are available to them. There might be justified concern about distress for patients who are informed that they are receiving second-best therapies. However, we argue that doctors should tailor information according to the needs of the individual patient. For most patients that will include a nuanced discussion about treatments that would be considered in other times but currently unavailable. That will sometimes be a difficult conversation, and require clinicians to be frank about limited resources and necessary rationing. However, transparency and honesty will usually be the best policy. (shrink)

In the UK, current policies and services for people with mental disorders, including those with intellectual disabilities (ID), presume that these men and women can, do, and should, make decisions for themselves. The new Mental Capacity Act (England and Wales) 2005 (MCA) sets this presumption into statute, and codifies how decisions relating to health and welfare should be made for those adults judged unable to make one or more such decisions autonomously. The MCA uses a procedural checklist to guide this (...) process of substitute decision-making. The personal experiences of providing direct support to seven men and women with ID living in residential care, however, showed that substitute decision-making took two forms, depending on the type of decision to be made. The first process, ‘strategic substitute decision-making’, paralleled the MCA’s legal and ethical framework, whilst the second process, ‘relational substitute decision-making’, was markedly different from these statutory procedures. In this setting, ‘relational substitute decision-making’ underpinned everyday personal and social interventions connected with residents’ daily living, and was situated within a framework of interpersonal and interdependent care relationships. The implications of these findings for residential services and the implementation of the MCA are discussed. (shrink)

This paper responds to the commentaries from Stacy Carter and Alan Cribb. We pick up on two main themes in our response. First, we reflect on how the process of setting standards for empirical bioethics research entails drawing boundaries around what research counts as empirical bioethics research, and we discuss whether the standards agreed in the consensus process draw these boundaries correctly. Second, we expand on the discussion in the original paper of the role and significance of the concept of (...) ‘integrating’ empirical methods and ethical argument as a standard for research practice within empirical bioethics. (shrink)

Next SectionMaking threats and offers to patients is a strategy used in community mental healthcare to increase treatment adherence. In this paper, an ethical analysis of these types of proposal is presented. It is argued (1) that the primary ethical consideration is to identify the professional duties of care held by those working in community mental health because the nature of these duties will enable a threat to be differentiated from an offer, (2) that threatening to act in a way (...) that would equate with a failure to uphold the requirements of these duties is wrong, irrespective of the benefit accrued through treatment adherence and (3) that making offers to patients raises a number of secondary ethical considerations that need to be judged on their own merit in the context of individual patient care. The paper concludes by considering the implications of these arguments, setting out a pathway designed to assist community mental healthcare practitioners to determine whether making a specific proposal to a patient is right or wrong. (shrink)

In this response, we first tackle what we take to be the core disagreement between ourselves and Hammersley, namely the justification for our model of social research ethics governance. We then consider what follows from our defence of governance for ethics review and show how these claims attend to the specific concerns outlined by Hammersley.

Dyck and Allen claim that the current model for mandatory ethical review of research involving human participants is unethical once the harms that accrue from the review process are identified. However, the assumptions upon which the authors assert that this model of research ethics governance is justified are false. In this commentary, I aim to correct these assumptions, and provide the right justificatory account of the requirement for research ethics review. This account clarifies why the subsequent arguments that Dyck and (...) Allen make in the paper lack force, and why the ‘governance problem’ in research ethics that they allude to ought to be explained differently. (shrink)

It is now broadly accepted that disability is a concept infused with both descriptive and evaluative meaning, such that invoking the concept of disability necessarily involves making judgements of moral value as well as describing certain facts about individuals. This paper aims to map the complex terrain that shapes our current understandings of disability by outlining five distinct ‘discourses of disability’. It is shown how the similarities and differences between the discourses hinge on different ways of making sense of the (...) descriptive and evaluative dimensions of the concept, and the relationships between these dimensions. The paper concludes by considering the specific implications that these different ways of elucidating the concept of disability might have for the provision of clinical ethics support, both in terms of shaping ethical decision-making relating to people with disabilities and in terms of framing the process of providing clinical ethics support itself. (shrink)

Restraint has recently become an important legal and clinical issue in England and Wales with the introduction of the Mental Capacity Act 2005 and the Deprivation of Liberty Safeguards introduced by the Mental Health Act 2007. The requirements of these two new pieces of legislation are complex, and therefore pose major challenges to the provision of high quality and patient-centred care, support and treatment in a range of health and social care settings. In this paper, the legal and ethical aspects (...) of physical restraint in an acute medical care environment are considered, and practical guidance is provided to individuals adopting methods of restraint to care for general hospital patients. Aspects of the Introduction below are written in the first person to reflect the personal experiences of the lead author. (shrink)

Through the lens of the Health Belief Model and Protection Motivation Theory, we analyzed interviews of 36 agricultural advisors in Indiana and Nebraska to understand their appraisals of climate change risk, related decision making processes and subsequent risk management advice to producers. Most advisors interviewed accept that weather events are a risk for US Midwestern agriculture; however, they are more concerned about tangible threats such as crop prices. There is not much concern about climate change among agricultural advisors. Management practices (...) that could help producers adapt to climate change were more likely to be recommended by conservation and Extension advisors, while financial and crop advisors focused more upon season-to-season decision making. We contend that the agricultural community should integrate long-term thinking as part of farm decision making processes and that agricultural advisors are in a prime position to influence producers. In the face of increasing extreme weather events, climatologists and advisors should work more closely to reach a shared understanding of the risks posed to agriculture by climate change. (shrink)

Community treatment orders are a legal mechanism to extend powers of compulsion into outpatient mental health settings in certain circumstances. Previous ethical analyses of these powers have explored a perceived tension between a duty to respect personal freedoms and autonomy and a duty to ensure that patients with the most complex needs are able to receive beneficial care and support that maximises their welfare in the longer-term. This empirical ethics paper presents an analysis of 75 interviews with psychiatrists, patients and (...) family carers to show how these ethical considerations map onto the different ways that community treatment orders are used and experienced in practice. A complex and nuanced account of how the requirements to respect patients’ autonomy, to respect patients’ liberty and to act beneficently should be interpreted in order to make judgements about the ethics of community treatment orders is presented. The article argues that, due to such complexity, no general ethical justification for community treatment orders can be provided, but a justification on the basis of the promotion of patients’ autonomy could provide an ethical reason for community mental health practitioners to make use of a community treatment order in some limited circumstances. (shrink)

Community treatment orders are a legal mechanism to extend powers of compulsion into outpatient mental health settings in certain circumstances. Previous ethical analyses of these powers have explored a perceived tension between a duty to respect personal freedoms and autonomy and a duty to ensure that patients with the most complex needs are able to receive beneficial care and support that maximises their welfare in the longer-term. This empirical ethics paper presents an analysis of 75 interviews with psychiatrists, patients and (...) family carers to show how these ethical considerations map onto the different ways that community treatment orders are used and experienced in practice. A complex and nuanced account of how the requirements to respect patients’ autonomy, to respect patients’ liberty and to act beneficently should be interpreted in order to make judgements about the ethics of community treatment orders is presented. The article argues that, due to such complexity, no general ethical justification for community treatment orders can be provided, but a justification on the basis of the promotion of patients’ autonomy could provide an ethical reason for community mental health practitioners to make use of a community treatment order in some limited circumstances. (shrink)

The relationship between a doctor and a patient is taken to be one of the most ethically significant dimensions of good medical care. After all, it is within the interactions that constitute this relationship that information is shared, that choices get determined, that reassurances are provided, that decisions are made and, ultimately, that care is given. Medical ethicists have devoted considerable effort to identifying different types of relationships, and in specifying their ideal components, most usually in general or abstract terms. (...) Indeed, I would suggest that medical ethicists are most comfortable when we are comparing different models of this relationship, or perhaps when advancing one account of this relationship that can provide the foundations for the most optimal approach to shared decision-making, for example by Sandman and Munthe.2 But, in truth, the doctor–patient relationship is most ethically interesting—and intellectually challenging—when scrutinised in its non-ideal forms. Ethicists who turn their attention to the front line of practice have demonstrated a tendency to see this relationship as one that is creaking at the seams, subject to manipulation or side-tracked entirely. So, is it the case that the doctor–patient relationship is under threat in contemporary medical practice? The answer to this question ought, I think, to be answered in the affirmative, though tentatively so. The role of medical ethicists is to identify precisely how such threats are materialising and to capture these in rich, detailed accounts of everyday medical encounters. Medical ethicists then also have a vital role to play in identifying and responding to these changes in a carefully reasoned way. Sometimes this is likely to involve pushing back and protecting those elements of the doctor–patient relationship that have fundamental value, regardless of context, changing social values, …. (shrink)

-/- Following the Mental Capacity Act (MCA) becoming law in 2005, and prior to its coming into force in 2007, there was a sustained effort to train support staff in the many social care settings where this new law was applicable. This training drive was necessary because, prior to the MCA, mental capacity law had evolved in the courts through consideration of a small number of cases that concerned serious medical treatments. These included the withdrawal of artificial nutrition and hydration (...) (Airedale NHS Trust v. Bland [1993]), blood transfusion (Re T [1993]), tissue donation (Re Y [1997]) and the provision of experimental medication for terminal illness (Simms v. Simms and another (2003)). In line with the Law Commission’s recommendations, the MCA extended the application of the law to ‘all acts in connection with care or treatment’ (MCA, Section 5), meaning that, overnight, social care settings and informal family care environments immediately fell within the scope of the legislation. (shrink)

Few topics in medical ethics stimulate as much heated debate as the question of the proper place of religious beliefs in medical practice. Typically, this debate is orientated towards questions about the religious beliefs held by medical practitioners, and in particular the appropriate limits that ought to be placed on these beliefs shaping care in ways that might impact negatively on patients’ interests. In this issue, however, it is the religious beliefs of patients themselves, and how these beliefs ought to (...) be responded to by clinicians, that is the focus of analysis. In their Feature Article, Greenblum and Hubbard articulate a strong position in response to this issue. Their fundamental claim is that clinicians should not deliberate about religious commitments with religious patients when these patients are drawing on these commitments in the medical decision-making process. They present two main arguments in support of this claim: the public reason argument and the fiduciary argument, and they contend that the discussion of religious considerations should be compartmentalised and farmed out to another appropriately placed person, such as a member of the clergy. Stimulating six commentaries that interrogate aspects of both arguments and the authors’ practical proposal, Greenblum and Hubbard’s paper gets to the heart of the challenge of reconciling the public role of medical practitioners with the private encounters that substantiate the performance of this role. Greenblum and Hubbard’s first argument is that clinicians ought to limit their deliberations in decisions made with patients to presenting ‘considerations that any reasonable person could recognise as counting in favour of something’. Drawing on the work of John Rawls and Robert Audi, the authors discount the place of religious reasons in …. (shrink)