Withholding or withdrawing life-saving ventilators can become necessary when resources are insufficient. In the USA, such rationing has unique social justice dimensions. Structural elements of dominant allocation frameworks simultaneously advantage white communities, and disadvantage Black communities—who already experience a disproportionate burden of COVID-19-related job losses, hospitalisations and mortality. Using the example of New Jersey’s Crisis Standard of Care policy, we describe how dominant rationing guidance compounds for many Black patients prior unfair structural disadvantage, chiefly due to the way creatinine and (...) life expectancy are typically considered.We outline six possible policy options towards a more just approach: improving diversity in decision processes, adjusting creatinine scores, replacing creatinine, dropping creatinine, finding alternative measures, adding equity weights and rejecting the dominant model altogether. We also contrast these options with making no changes, which is not a neutral default, but in separate need of justification, despite a prominent claim that it is simply based on ‘objective medical knowledge’. In the regrettable absence of fair federal guidance, hospital and state-level policymakers should reflect on which of these, or further options, seem feasible and justifiable.Irrespective of which approach is taken, all guidance should be supplemented with a monitoring and reporting requirement on possible disparate impacts. The hope that we will be able to continue to avoid rationing ventilators must not stand in the way of revising guidance in a way that better promotes health equity and racial justice, both to be prepared, and given the significant expressive value of ventilator guidance. (shrink)

The Covid‐19 pandemic needs to be considered from two perspectives simultaneously. First, there are questions about which policies are most effective and fair in the here and now, as the pandemic unfolds. These polices concern, for example, who should receive priority in being tested, how to implement contact tracing, or how to decide who should get ventilators or vaccines when not all can. Second, it is imperative to anticipate the medium‐ and longer‐term consequences that these policies have. The case of (...) vaccine rationing is particularly instructive. Ethical, epidemiological, and economic reasons demand that rationing approaches give priority to groups who have been structurally and historically disadvantaged, even if this means that overall life years gained may be lower. (shrink)

Implementing equity principles in resource allocation is challenging. In one approach, some US states implemented race-based prioritisation of COVID-19 vaccines in response to vast racial inequities in COVID-19 outcomes, while others used place-based allocation. In a nationally representative survey of n=2067 US residents, fielded in mid-April 2021, we explored the public acceptability of race-based prioritisation compared with place-based prioritisation, by offering vaccines to harder hit zip codes before residents of other zip codes. We found that in general, a majority of (...) respondents supported the place-based approach, and a substantial proportion supported the race-based plan. Support was higher among Democrats compared with Republicans. All US residents became eligible for vaccines on 19 April 2021 but as of this writing, equitable uptake of vaccines remains urgent not only for first doses for adults but also for boosters and for children. Our findings also provide a benchmark for future pandemic planning that racial and social justice in vaccine allocation are salient considerations for the public. The findings may furthermore be of interest to policy makers designing vaccine allocation frameworks in countries with comparable health disparities across social, ethnic and racial groups, and more broadly, for those exploring ways of promoting equity in resource allocation outside of a pandemic setting. (shrink)

Although the responsibility for health debate has intensified in several ways between Norman Daniels’ 1985 Just healthcare and Just health: meeting health needs fairly of 2008, comparatively little space is dedicated to the issue in Just health, and Daniels notes repeatedly that his account “says nothing about personal responsibility for health”. Daniels considers health responsibility mainly in a particular luck-egalitarian version which he rejects because of its potentially unfeasible, penalising and inhumane character. But I show that he nonetheless acknowledges and (...) endorses explicitly other dimensions of health responsibility. I develop a wider, more nuanced and less punitive concept of health responsibility, which expands Daniels’ brief consideration and is compatible with the overall approach set out in Just health. In its application to preventative medicine and health promotion in particular, the concept is suited to support and complement the notion that “health is special”, which is central in Just health. The concept of health responsibility as co-responsibility specifies the subjects and objects of health responsibilities. It permits the attribution of responsibility without blame and disconnects the question of assigning responsibility from decisions about entitlement to treatment or different status in prioritisation decisions. This approach secures conceptual plausibility and clarity of the concept of health responsibility, is of use in policy making, and can help reduce political tensions. (shrink)

Bonuses, as incentives or rewards for health -related behavior, feature prominently in German social health insurance. Their goal is centered around promoting personal responsibility, but reducing overall health -care expenditure and enabling competition between sickness funds also play a role. The central position of personal responsibility in German health -care policy is described, and a framework is offered for an analysis of the ethical issues raised by policies seeking to promote responsibility. The framework entails seven tests relating to: solidarity; equality (...) and equity; intrusiveness; attributability and opportunity of choice; evidence, rationale, and feasibility; affected third parties; and coherence. It is contended that a focus on tests, in particular from within contractualism, is the most appropriate way of addressing the question of health responsibility in pluralistic societies. However, taken by themselves, the tests also allow an identification of the key ethical issues by particular policies, which are illustrated by applying the framework to particular bonus polices. (shrink)

Rebecca Brown and Julian Savulescu1 focus on individuals’ responsibility regarding health-related behaviours. They rightly argue that paying attention to diachronic and dyadic aspects of responsibility can further illuminate the highly multifaceted concept of personal responsibility for health. Their point of departure is a pragmatic one. They note that personal responsibility ‘is highly intuitive, [that] responsibility practices are a commonplace feature of almost all areas of human life and interpersonal relationship [and that] the pervasiveness of this concept [suggest] the improbability of (...) banishing it entirely’. Indeed, despite—or perhaps even quite independent of—decades of mostly sceptical conceptual analysis of the concept of personal responsibility by philosophers and others, it endures, if not flourishes. These separate dynamics raise the question of how, in years ahead, the debate on responsibility can be furthered most effectively, and how nuanced conceptual distinctions can effectively inform policy and practice. The authors’ table 1 matrix illustrates how different levels of control and knowledge people had at different timepoints might be grouped in categories of low, moderate or high demandingness: for policy makers sympathetic to the authors’ proposal that high levels of demandingness should undermine responsibility attributions, or for advocacy groups seeking to lobby on their behalf, several questions likely arise, including: How should …. (shrink)

We respond to recent comments on our proposal to improve justice in ventilator triage, in which we used as an example New Jersey’s publicly available and legally binding Directive Number 2020-03. We agree with Bernard Lo and Doug White that equity implications of triage frameworks should be continually reassessed, which is why we offered six concrete options for improvement, and called for monitoring the consequences of adopted triage models. We disagree with their assessment that we mis-characterised their Model Guidance, as (...) included in the NJ Directive, in ways that undermine our conclusions. They suggest we erroneously described their model as a two-criterion allocation framework; that recognising other operant criterion reveals it ‘likely mitigate[s] rather than exacerbate[s] racial disparities during triage’, and allege that concerns about inequitable outcomes are ‘without evidence’. We highlight two major studies robustly demonstrating why concerns about disparate outcomes are justified. We also show that White and Lo seek to retrospectively—and counterfactually—correct the version of the Model Guideline included in the NJ Directive. However, as our facsimile reproductions show, neither the alleged four-criteria form, nor other key changes, such as dropping the Sequential Organ Failure Assessment score, are found in the Directive. These points matter because our conclusions hence stand, because the public version of the Model Guidance had not been updated to reduce the risk of inequitable outcomes until June 2021 and NJ’s Directive still does not reflect these revisions, and, hence, represents a less equitable version, as acknowledged by its authors. We comment on broader policy implications and call for ways of ensuring accurate, transparent and timely updates for users of high-stakes guidelines. (shrink)

So-called ‘anonymous’ tissue samples are widely used in research. Because they lack externally identifying information, they are viewed as useful in reconciling conflicts between the control, privacy and confidentiality interests of those from whom the samples originated and the public (or commercial) interest in carrying out research, as reflected in ‘consent or anonymise’ policies. High level guidance documents suggest that withdrawal of consent and samples and the provision of feedback are impossible in the case of anonymous samples. In view of (...) recent developments in science and consumer-driven genomics the authors argue that such statements are misleading and only muddle complex ethical questions about possible entitlements to control over samples. The authors therefore propose that terms such as ‘anonymised’, ‘anonymous’ or ‘non-identifiable’ be removed entirely from documents describing research samples, especially from those aimed at the public. This is necessary as a matter of conceptual clarity and because failure to do so may jeopardise public trust in the governance of large scale databases. As there is wide variation in the taxonomy for tissue samples and no uniform national or international standards, the authors propose that a numeral-based universal coding system be implemented that focuses on specifying incremental levels of identifiability, rather than use terms that imply that the reidentification of research samples and associated actions are categorically impossible. (shrink)

Nuffield Council on Bioethics, London * Corresponding author: Nuffield Council on Bioethics, 28 Bedford Square, London WC1B 3JS, UK. Email: hschmidt{at}nuffieldbioethics.org ' + u + '@' + d + ' '//--> Abstract In November 2007, the Nuffield Council on Bioethics published the report Public Health: Ethical Issues . While the report has been welcomed by a wide range of stakeholders, there has also been some criticism. First, it has been suggested that it is not clear why, in developing its ‘stewardship (...) model’, the Council felt the need to go beyond the liberal position developed by John Stuart Mill—what is it that the stewardship model adds? Second, it is suggested that the Report is confused about the concept of paternalism. Third, it is argued that the discussion of the concept of stewardship is lacking in detail and substance. We clarify the Working Party's thinking regarding these three areas, which demonstrates the robustness of the framework set out in the report. CiteULike Connotea Del.icio.us What's this? (shrink)

Incentive programs have been criticized due to concerns that extrinsic rewards can ‘crowd out’ intrinsic motivation, and also that such programs might exert a corrupting influence on those receiving the incentive. Jonathan Wolff has argued that while these worries are in some instances well grounded, incentives can also operate by liberating people from social pressures that stand in the way of their intrinsic motivations. We further develop Wolff's insight by articulating a framework for assessing such incentives and discussing several areas (...) of public health where incentives may play a positive role. In so doing, we describe the limitations of Wolff's thesis as well as the opportunities it presents. Finally, we suggest that there is an additional attractive feature of incentives that has been overlooked, which is their capacity to serve as ‘conversation makers’. By providing people an occasion to discuss reasons for and against various health behaviors, incentives have the potential not only to impact the health behavior of individuals but to affect cultural change at the population level. (shrink)

Withholding or withdrawing life-saving ventilators can become necessary when resources are insufficient. With rising cases in many countries, and likely further peaks in the coming colder seasons, ventilator triage guidance remains a central part of the COVID-19 policy response. The dominant model in ventilator triage guidelines prioritises the ethical principles of saving the most lives and saving the most life-years. We sought to ascertain to what extent this focus aligns, or conflicts, with the preferences of disadvantaged minority populations. We conducted (...) a bibliographical search of PubMed and Google Scholar and reviewed all ventilator rationing guidelines included in major recent systematic reviews, yielding 589 studies before screening. Post screening, we found six studies comprising a total of 10 591 participants, with 1247 from disadvantaged populations. Three studies reported findings stratified by race and age, two of which stratified by income. Studies included two to seven principles; all included ‘save the most lives’. Involvement of disadvantaged minority populations in eliciting preferences is very limited; few studies capture race and income. This is concerning, as despite relatively small numbers and framing effects there is an observable and plausible trend suggesting that disadvantaged groups worry that dominant principles reduce their chances of receiving a ventilator. To avoid compounding prior historical and structural disadvantage, policy makers need to engage more fully with these populations in designing and justifying ventilator rationing guidance and review their adequacy. Likewise, clinicians need to be aware that their implementation of dominant triage guidelines is viewed with higher levels of concern by minority populations. (shrink)

In October 2005, the United Nations Educational, Scientific and Cultural Organization adopted the Universal Declaration on Bioethics and Human Rights . A concept of central importance in the declaration is that of “human dignity”. However, there is lack of clarity about its scope, especially concerning the question of whether prenatal human life has the same dignity and rights as born human beings. This ambiguity has implications for the interpretation of important articles of the delcaration, including 2, 4, 8, 10 and (...) 11. The paper applies relevant provisions of the UDBHR to specific cases, addresses problems of internal consistency and considers attempts at clarifying the scope of “human dignity” by the negotiating parties. An analysis of the important relationship between the UDBHR and the Universal Declaration of Human Rights, to which the UDBHR refers in its title and elsewhere, shows that because of a crucial emphatic asymmetry, a broad reading according to which the UDBHR must be understood to ascribe human rights and dignity to prenatal life is untenable. However, the view that the UDBHR confers human rights and dignity on humans from the moment of birth onwards is robust and defensible. This conclusion is important for a proper understanding of the declaration and its use, as stated in Articles 1 and 22, the latter urging states “… to give effect to the principles … in this declaration”. Similarly, it has implications for the use of the declaration in the wider context of bioethics-related law and policy, as well as in academic and other discussions where increasing reference to the UDBHR is likely. (shrink)

The World Medical Association's Declaration of Helsinki is one of the most important and influential international research ethics documents. Launched in 1964, when ethical guidance for research was scarce, the Declaration comprised eleven basic principles and provisions on clinical research. The document has since evolved to a complex set of principles, norms, and directions for action of varying degrees of specificity, ranging from specific rules to broad aspirational statements. It has been revised six times in an effort to maintain its (...) influence. While all revisions were the result of vigorous debate, the 2000 revision and two subsequent notes of clarification spurred particular controversy surrounding the use of placebo in clinical research and the standard of care and post-trial obligations in research in developing countries. Several institutions opted to cite earlier versions of the Declaration, and the U.S. Food and Drug Administration recently removed all reference to the Declaration in its approval requirements for drugs and biological products that are studied outside the United States. (shrink)

The theory stating that oxidative stress is at the root of several diseases is extremely popular. However, so far, no antioxidant is recommended or offered by healthcare systems neither approved as therapy by regulatory agencies that base their decisions on evidence-based medicine. This is simply because, so far, despite many preclinical and clinical studies indicating a beneficial effect of antioxidants in many disease conditions, randomised clinical trials have failed to provide the evidence of efficacy required for drug approval. In this (...) review, we discuss the levels of evidence required to claim causality in preclinical research on OS, the weakness of the oversimplification associated with OS theory of disease and the importance of the narrative in its popularity. Finally, from a more translational perspective, we discuss the reasons why antioxidants acting by scavenging reactive oxygen species might not only prevent their detrimental effects but also interfere with essential signalling roles. We propose that ROS have a complex metabolism and are generated by different enzymes at diverse sites and with different timing. Aggregating this plurality of systems in a single theory of disease may not be the best way to develop new drugs, and future research may need to focus on specific oxygen-toxifying pathways rather than on non-specific ROS scavengers. Finally, similarly to what is nowadays required for clinical trials, we recommend making unpublished data available in repositories, as this will allow big data approaches or meta-analyses without the blinders of the publication bias. (shrink)

A learning health system (LHS) seeks to establish a closer connection between clinical care and research and establishes new responsibilities for healthcare providers as well as patients. A new set of technological approaches in medication adherence monitoring can potentially yield valuable data within an LHS, and raises the question of the scope and limitations of patients’ responsibilities to use them. We argue here that, in principle, it is plausible to suggest that patients have a prima facie obligation to use novel (...) adherence monitors. However, the strength of the obligations depends considerably on the extent to which data that adherence monitors generate are, in fact, used to further the goals of LHSs. The way in which data ownership is structured in the USA poses a considerable challenge here, while the European Union framework offers a more promising alternative. (shrink)

One of six commentaries on “Obesity: Chasing an Elusive Epidemic,” by Daniel Callahan, from the January‐February 2013 issue.

The world appears causal in the sense that the result of a measurement may depend on the past history of the observed system, but not on what the experimenter will do with the system after the measurement. This raises the question whether noncausality at a macroscopic level would necessarily lead to an “unreasonable” world. The study of a model world with axiomatically well-specified properties shows that noncausal systems can be discussed in a logically consistent manner so that noncausality might well (...) exist in the real world as a weak, but so far overlooked, effect. (shrink)

Eugene Wigner and others have speculated that the “collapse of the state vector” during an observation might be a physically real process so that some modification of current quantum theory would be required to describe the interaction with a conscious observer appropriately.Experimental reports on the “psychokinetic effect” as a mental influence on the outcome of quantum jumps suggest that perhaps this effect might be vital for an understanding of the observer's role in quantum mechanics.Combining these two speculations we introduce a (...) reduction principle that provides for the gradual reduction of a macroscopically ambiguous state and allows simultaneously for the occurrence of some psychokinetic effect in the process of observation.The resulting model leads to many of the paradoxical, but logically consistent, features of the psychokinetic effect that have been reported, and makes further testable predictions.The model does not touch on the more profound questions of consciousness. But the model implies that the result of a conscious observation, the collapse of the state vector, becomes accessible to the experimenter, with the psychokinetic effect as probe: Whether Schrödinger's cat has not or has collapsed the state vector determines whether or not the later human observer can still exert a psychokinetic influence on the result. (shrink)

Ethics advisory groups, in various forms, have existed for at least 50 years in the United States and other countries. In science and biomedicine, four principal types of committees can be distinguished: policy-making and/or advisory committees, health professional association committees, health care ethics committees, and research ethics committees. Overall, these bodies have been of use to governments, policy makers, health care professionals, and the public in considering ‘what is ethical’ and ‘what is unethical’ in areas such as research involving humans (...) or animals or environmental questions such as whether to use genetically modified crops. This paper concentrates on a particular and... (shrink)

This chapter explores two questions in detail: How should we determine the threshold for costs that individuals are asked to bear through insurance premiums or care-related out-of-pocket costs, including user fees and copayments? and What is an adequate relationship between costs and benefits? This chapter argues that preventing impoverishment is a morally more urgent priority than protecting households against income fluctuations, and that many health insurance plans may not adequately protect individuals from health care costs that threaten to drop their (...) financial status below a decent minimum. A design that places greater emphasis on preventing impoverishment and finances the achievement of that goal by reducing unnecessary subsidies to better-off households would better accord with a sufficientarian approach to health care. -/- . (shrink)

The World Health Organization (WHO) is currently in advanced stages of developing a ‘WHO convention, agreement, or other international instrument on pandemic prevention, preparedness and response’ (also known as WHO CA+, referred to below as: Pandemic Agreement). 1 Rightly, the instrument places equity at the centre. Yet, it currently also omits reference to an impactful tool to promote equity that has been adopted in an unprecedented manner during COVID-19—a set of measures known as disadvantage indices. Embedding disadvantage indices would provide (...) concrete constructive guidance; align the Pandemic Agreement with the use of indices by other United Nations (UN) agencies; help realise the Agreement’s goal of addressing social and other determinants of health within countries, and furthermore offer feasible ways improving equity in allocation across countries. WHO member states began work on a Pandemic Agreement in December 2021. The current timeline envisages a final version to be considered by... (shrink)

Traditional navigation visualization utilizes two-dimensional. maps for road guidance or arrow symbols for turn by turn information. While the advantage of map views is supposed to be the inherent understanding of the surroundings, often these schematic line-drawing bird's eye views are rather confusing than helpful because they cannot provide an overview and an appropriate level of detail in an area of interest at the same time, i.e. the user is forced to change between different resolutions. In this paper we describe (...) a 3D visualization system for vehicle navigation that overcomes these shortcomings by providing a realistic and perspective 3D view of the environment. (shrink)

An exact formulation of the frequency interpretation of probability is proposed on the basis of G. Ludwig's concept of physical theories. Starting from a short outline of this concept, a formal definition of weak approximate reduction is developed, which covers the reduction of probability to frequency as a special case.

Psychological time—as distinct from physical time—divides the past from the future by means of the experienced present and serves as a frame of reference for objects, events, actions, and persons. There are cases when our understanding of objects and events gains in depth with every additional time dimension, until we are able to arrange all the data in a meaningful sequence ranging from the past through the present to the future across time. A description of city traffic when confined to (...) the present is one step towards analysing special problems and understanding congestion in certain areas. The historical development of the city offers additional insight into the evolution of bottlenecks, while current changes, made by the municipal authorities, can only be understood in connection with a long-term development plan. A lecturer on town planning will, therefore, offer his audience a more profound understanding of the subject by combining a description of the visible present with a causal explanation of the past and a teleological account of future projects. (shrink)

Should financial incentives be offered to mothers for breastfeeding? Given the significant socioeconomic and sociodemographic differences in breastfeeding in the USA, researchers and policymakers are exploring the role of financial incentives for breastfeeding promotion with the objective of increasing uptake and reducing disparities. Despite positive outcomes in other health domains, the acceptability of financial incentives is mixed. Financial incentives in the context of infant feeding are particularly controversial given the complex obligations that characterize decisions to breastfeed. After situating the specific (...) ethical tensions related to personal responsibility, fairness, and intrusiveness, we argue that exploring carefully designed financial incentives can be ethically justified to support breastfeeding uptake particularly given established medical guidelines that support breastfeeding benefits, wide socioeconomic and racial/ethnic disparities and notable influences in the broader choice architecture of infant feeding in the USA. Additional empirical research is warranted to better understand effectiveness, cost and specific ethical concerns related to free and informed choice. (shrink)