Sapfo Lignou

The National Health Service operates under significant resource constraints, both financially and in terms of staffing, leading to challenges in providing comprehensive healthcare for all. This poses a problem for commissioners: how do we prioritise treatment allocation? Chris Newdick’s influential work in ethics and law has shaped discourse in this area for over three decades. However, we critique a specific aspect of Newdick’s work concerning individual funding requests (IFRs) within the healthcare resource allocation system. The allocation problem involves balancing population-wide healthcare needs with the ethical imperative to treat individuals. Decision-making frameworks like the ‘Accountability for Reasonableness’ (A4R) framework aim to address this by fostering fair processes. In the United Kingdom, local priority forums, guided by ethical frameworks, play a crucial role in resource allocation decisions. While these processes strive to be fair, they are not flawless. These processes cannot consider every potential patient perspective, circumstance or reason for needing treatment. To address this, A4R frameworks include mechanisms for revision and appeals. IFRs form an important part of this picture by providing a recourse for patients whose cases may not have been adequately considered because they are in some sense unusual or ‘exceptional’. However, current processes often rely on a problematic interpretation of ‘exceptionality’ which fails to align with A4R principles. This interpretation sometimes excludes those who ought to be included, and includes those who ought to be excluded. We argue for a revised understanding of exceptionality to ensure fairness and effectiveness in resource allocation processes informed by Newdick’s work.

The UK government has recently committed to adopting a new policy—dubbed ‘Martha’s Rule’—which has been characterised as providing patients the right to rapidly access a second clinical opinion in urgent or contested cases. Support for the rule emerged following the death of Martha Mills in 2021, after doctors failed to admit her to intensive care despite concerns raised by her parents. We argue that framing this issue in terms of patient rights is not productive, and should be avoided. Insofar as the ultimate goal of Martha’s Rule is the provision of a clinical service that protects patient safety, an approach that focuses on the obligations of the health system—rather than the individual rights of patients—will better serve this goal. We outline an alternative approach that situates rapid clinical review as part of a suite of services aimed at enhancing and protecting patient care. This approach would make greater progress towards addressing the difficult systemic issues that Martha’s Rule does not, while also better engaging with the constraints of clinical practice.

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.

Recent literature has drawn attention to the complex relationship between health care and the environmental crisis. Healthcare systems are significant contributors to climate change and environmental degradation, and the environmental crisis is making our health worse and thus putting more pressure on healthcare systems; our health and the environment are intricately linked. In light of this relationship, we might think that there are no trade‐offs between health and the environment; that healthcare decision‐makers have special responsibilities to the environment; and that environmental values should be included in healthcare resource‐allocation decisions. However, we argue that these claims are mistaken. The environmental crisis involves a wider range of considerations than just health. There is a plurality of reasons to act on the environment; we might do so to protect the natural world, to prevent catastrophes in other parts of the world, or to avert climate war and displacement. Trading‐off between health care and environmental sustainability is thus unavoidable and requires sensitivity to all these reasons. Healthcare decision‐makers are not well placed to be sensitive to these reasons, nor do they have the democratic authority to make such value judgements. Therefore, decisions about environmental sustainability interventions should be made at a ‘higher level’ of resource allocation. Importantly, hospitals have environmental duties but not environmental responsibilities; their job is to provide the best healthcare possible within the constraints given to them, not to choose between health care and other goods.

In his article, Johannes Kneiss, argues convincingly that a generational ban of smoking need not necessarily disadvantage, or treat as moral unequals, future generations. While a ban need not be inegalitarian in these particular ways, we argue that this is insufficient to establish a ban to be appropriately relationally egalitarian. In what follows, we raise a couple of other issues that we would like to see addressed before we can be confident in such a law. First, it remains underexplored, whether current generations would be disadvantaged or treated as moral unequals by a ban. Plausibly, being excluded from the ban could show insufficient concern for current generations. By not acting paternalistically towards them, current generations miss out on the health benefits afforded to the young, which might display a greater valuing of younger lives than older lives. Kneiss briefly considers this objection, but quickly dismisses it: “given that some existing smokers strongly wish to retain the option to smoke, […] a ban across the board cannot be said to advance their interests, as conceived by these smokers themselves”.1 However, in our view, this is too quick. Appealing to the smokers’ own conceptions of their interests to establish their interests presumes that the smokers know what is in their …

Healthcare delivery and access, both in the United States and globally, were negatively affected during the entirety of the COVID-19 pandemic. This was particularly true during the first year when countries grappled with high rates of illness and implemented non-pharmaceutical interventions such as stay-at-home orders. Among children with special healthcare needs, research from the United Kingdom (U.K.) has shown that the pandemic response uniquely impacted various aspects of their care, including decreased access to care, delays in diagnosis, and poorer chronic disease control. In response to these findings, and to begin to comprehend whether the concerning findings from the nationalized system of healthcare in the U.K. extend to the highly dissimilar United States (U.S.) healthcare context, we reviewed the literature on alterations in access to and delivery of care during the early stages of the COVID-19 pandemic for children with special healthcare needs in the U.S. We then utilize these findings to consider the ethical and policy considerations of alterations in healthcare provision during pandemics and crisis events in the U.K. and U.S. and make recommendations regarding how the needs of CSHCN should be considered during future responses.

In their upcoming article, Henk Jasper van Gils-Schmidt and Sabine Salloch highlight the supposed responsibilities of healthcare professionals in addressing the global health challenges posed by climate change. They argue that healthcare professionals’ duties to future generations and their ‘climate-related obligations’ have been neglected, primarily due to potential conflicts with other responsibilities, such as providing optimal care to current patients and maintaining patient trust. The authors suggest that these competing obligations should be viewed as part of the multifaceted identities individuals hold, encompassing roles as both physicians and environmentalists, each with normative and competing commitments. They propose that a transformative shift in physicians’ professional ethos, expanding from the predominant focus on individual patients to include obligations towards climate protection, could pave the way for identifying effective mechanisms to address these challenges. While acknowledging the authors’ emphasis on sustainable healthcare practices, we argue that a duty to climate protection as part of healthcare professionals’ identity lacks ethical support. We identify serious concerns that stem from the transformative shift in physicians’ professional ethos, particularly in the authors’ presentation of reasons for action. First, envisaging a stable disposition that compels healthcare professionals to ensure optimal care conditions for both immediate and potential future encounters is unrealistic. Such a scenario would necessitate a nuanced and multifaceted evaluation, weighing …

Many research institutions and funders have recently stated their commitment to actively support and promote ‘Equality, Diversity and Inclusion’ (EDI) in various aspects of health research including Patient and Public Involvement (PPI). However, translating this commitment into specific research projects presents significant challenges that existing approaches, practical guidelines and initiatives have not adequately addressed. In this paper, we explore how the lack of clear justifications for the EDI commitment in existing guidelines inadvertently complicates the work of those involved with PPI and we stress the need for conceptual clarity for any EDI effort to yield meaningful results. Our focus centres on the first principle of the EDI discourse, ‘equality’, particularly in the form of ‘equality of opportunity’ as outlined in current guidance provided by the National Institute of Health Research in the United Kingdom. We examine challenges related to justifying and implementing a general, unspecified commitment to equality of opportunity and explain that this reflects a lack of consensus regarding the moral value of PPI in research – a profound problem that remains unaddressed. We then discuss how the presence of several opposing moral perspectives on PPI, makes determining the most appropriate way of addressing barriers to involvement complex and controversial, raising ethical implications for the work of health researchers, PPI specialists and coordinators. Finally we make suggestions on how future research can enrich the concept of ‘equality of opportunity’ in PPI and improve practice. While our primary focus is on the NIHR, a strong advocate of PPI in research, this analysis will point to normative and ethical considerations that may be relevant to other research institutions and funding organisations aiming to promote equality of opportunity in their public and patient involvement strategies.

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.

Research ethics is an integral part of research, especially that involving human subjects. However, concerns have been expressed that research ethics has come to be seen as a procedural concern focused on a few well-established ethical issues that researchers need to address to obtain ethical approval to begin their research. While such prospective review of research is important, we argue that it is not sufficient to address all aspects of research ethics. We propose retrospective review as an important complement to prospective review. We offer two arguments to support our claim that prospective review is insufficient. First, as currently practiced, research ethics has become for some a ‘tick box’ exercise to get over the ‘hurdle’ of ethics approval. This fails to capture much of what is important in ethics and does not promote careful reflection on the ethical issues involved. Second, the current approach tends to be rules-based and we argue that research ethics should go beyond this to develop people’s capacity to be sensitive to the relevant moral features of their research, their ethical decision-making skills and their integrity. Retrospective review of a project’s ethical issues, and how they were addressed, could help to achieve those aims better. We believe that a broad range of stakeholders should be involved in such retrospective review, including representatives of ethics committees, participating communities and those involved in the research. All stakeholders could then learn from others’ perspectives and experiences. An open and transparent assessment of research could help to promote trust and understanding between stakeholders, as well as identifying areas of agreement and disagreement and how these can be built upon or addressed. Retrospective review also has the potential to promote critical reflection on ethics and help to develop ethical sensitivity and integrity within the research team. Demonstrating this would take empirical evidence and we suggest that any such initiatives should be accompanied by research into their effectiveness. Our article concludes with a discussion of some possible objections to our proposal, and an invitation to further debate and discussion.

The purpose of this paper is to propose an alternative account by which the ethical threshold of acceptable risk in paediatric research can be assessed. Three popular interpretations of the minimal risk threshold and the problems they raise when applied in the research context are presented. First, the “risks of daily life” standard and the “routine examinations” standard are addressed. It is argued here that neither of them can provide a satisfactory morally justified framework within which risks during paediatric non-therapeutic research should be assessed. The alternative view of the “charitable participation” standard is then discussed and the argument advanced that despite its advantages, it generates unavoidable difficulties when considered in the context of medical research. Finally, the author argues that consideration of the risk to which parents are willing to expose their children in a vaccination programme in the case of an infectious disease, which does not constitute a significant threat to them, can facilitate the definition of this threshold. Although the proposed account shares some of its strong points with those already existing, it does not lead to inconsistencies when applied in research context

BACKGROUND: There is growing interest in the ethics of cluster trials, but no literature on the uncertainties in defining communities in relation to the scientific notion of the cluster in collaborative biomedical research. METHODS: The views of participants in a community-based cluster randomised trial (CRT) in Mumbai, India, were solicited regarding their understanding and views on community. We conducted two focus group discussions with local residents and 20 semi-structured interviews with different respondent groups. On average, ten participants took part in each focus group, most of them women aged 18-55. We conducted semi-structured interviews with ten residents (nine women and one man) lasting approximately an hour each and seven individuals (five men and two women) identified by residents as local leaders or decision-makers. In addition, we interviewed two Municipal Corporators (locally elected government officials involved in urban planning and development) and one representative of a political party located in a slum community. RESULTS: Residents' sense of community largely matched the scientific notion of the cluster, defined by the investigators as a geographic area, but their perceived needs were not entirely met by the trial. CONCLUSION: We examined whether the possibility of a conceptual mismatch between 'clusters' and 'communities' is likely to have methodological implications for a study or to lead to potential social disharmony because of the research interventions, arguing that it is important to take social factors into account as well as statistical efficiency when choosing the size and type of clusters and designing a trial. One method of informing such a design would be to use existing forums for community engagement to explore individuals' primary sense of community or social group and, where possible, to fit clusters around them.

Cluster randomised trials are an increasingly important methodological tool in health research but they present challenges to the informed consent requirement. In the relatively limited literature on the ethics of cluster research there is not much clarity about the reasons for which seeking informed consent in cluster randomised trials may be morally challenging. In this paper, I distinguish between the cases where informed consent in cluster trials may be problematic due to the distinct features of ‘population-based’ interventions, which have not been adequately discussed in the research ethics literature, and the cases where informed consent may be problematic for reasons that investigators also encounter in other research designs. I claim that informed consent requirements in cluster trials should be adjusted to the level of risk involved, arguing for a more comprehensive notion of research risk than that currently found in the research ethics guidelines, and the amount of freedom to be sacrificed in relation to a particular research aim. I conclude that these two factors are the most important to consider when assessing whether a cluster study should proceed when informed consent is infeasible or difficult to obtain.

The aim of this article is to examine whether informational manipulation, used intentionally by the researcher to increase recruitment in the research study, can be morally acceptable. We argue that this question is better answered by following a non-normative account, according to which the ethical justifiability of informational manipulation should not be relevant to its definition. The most appropriate criterion by which informational manipulation should be considered as morally acceptable or not is the researcher’s special moral duties towards their subjects. We also propose that a broader definition of manipulation of information should be adopted (than that already existing in the literature) since informational manipulation can affect not only a person’s beliefs but also their desires in decision-making. We conclude that manipulation of information can either be used to protect the potential subject and facilitate the informed consent process or be used to exploit and merely use a person for scientific goals.