Ethical analysis examining the prioritisation of living donor transplantation in times of healthcare rationing.

The transplant community has faced unprecedented challenges balancing risks of performing living donor transplants during the COVID-19 pandemic with harms of temporarily suspending these procedures. Decisions regarding postponement of living donation stem from its designation as an elective procedure, this despite that the Centers for Medicare and Medicaid Services categorise transplant procedures as tier 3b (high medical urgency-do not postpone). In times of severe resource constraints, health systems may be operating under crisis or contingency standards of care. In this manuscript, the United Network for Organ Sharing Ethics Workgroup explores prioritisation of living donation where health systems operate under contingency standards of care and provide a framework with recommendations to the transplant community on how to approach living donation in these circumstances.To guide the transplant community in future decisions, this analysis suggests that: (1) living donor transplants represent an important option for individuals with end-stage liver and kidney disease and should not be suspended uniformly under contingency standards, (2) exposure risk to SARS-CoV-2 should be balanced with other risks, such as exposure risks at dialysis centres. Because many of these risks are not quantifiable, donors and recipients should be included in discussions on what constitutes acceptable risk, (3) transplant hospitals should strive to maintain a critical transplant workforce and avoid diverting expertise, which could negatively impact patient preparedness for transplant, (4) transplant hospitals should consider implementing protocols to ensure early detection of SARS-CoV-2 infections and discuss these measures with donors and recipients in a process of shared decision-making.

COVID-19 ventilator rationing protocols: why we need to know more about the views of those with most to lose.

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.

Ethical allocation of future COVID-19 vaccines.

The COVID-19 pandemic will likely recede only through development and distribution of an effective vaccine. Although there are many unknowns surrounding COVID-19 vaccine development, vaccine demand will likely outstrip early supply, making prospective planning for vaccine allocation critical for ensuring the ethical distribution of COVID-19 vaccines. Here, we propose three central goals for COVID-19 vaccination campaigns: to reduce morbidity and mortality, to minimise additional economic and societal burdens related to the pandemic and to narrow unjust health inequalities. We evaluate five prioritisation approaches, assess their likely impact on advancing the three goals of vaccine allocation and identify open scientific questions that may alter their outcomes. We argue that no single prioritisation approach will advance all three goals. Instead, we propose a multipronged approach that considers the risk of serious COVID-19 illness, instrumental value and the risk of transmission, and is guided by future research on COVID-19-specific clinical and vaccine characteristics. While we focus this assessment on the USA, our analysis can inform allocation in other contexts.

Sustained ethical analysis of global dilemmas and country-level decision making during and post the COVID-19 pandemic: A systematic review

The COVID-19 pandemic has highlighted the vulnerability of countries worldwide and their abilities to cope with the fast-paced demands of the research and medical community. A key to promoting ethical decision-making frameworks is by calibrating the sustainability at regional, national, and global levels to incorporate coordinated reforms. We performed a sustained ethical analysis and critically reviewed evidence addressing country-level responses to practices during the COVID-19 pandemic using PubMed (MEDLINE), Scopus, and CINAHL. The World Health Organization's ethical framework proposed for the entire population during the pandemic was applied to thematically delineate findings under equality, best outcomes (utility), prioritizing the worst off, and prioritizing those tasked with helping others. The findings demarcate ethical concerns about the validity of drug and vaccine trials in developing and developed countries, hints of unjust healthcare organizational policies, lack of equal allocation of pertinent resources, miscalculated allocation of resources to essential workers and stratified populations.

Promoting equity with a multi-principle framework to allocate scarce ICU resources.

We wholeheartedly agree with Schmidt and colleagues' efforts to promote equity in intensive care unit (ICU) triage. We also take issue with their characterisation of the New Jersey (NJ) allocation framework for ICU beds and ventilators, which is modelled after the multi-principle allocation framework we developed early in the pandemic. They characterise it as a two-criterion allocation framework and claim-without evidence-that it will 'compound disadvantage for black patients'. However, the NJ triage framework-like the model allocation policy we developed-actually contains four allocation criteria: the two criteria that the authors mentioned (chances for survival and near-term prognosis) and two criteria that they failed to mention which we included to promote equity: giving priority to frontline essential workers and giving priority to younger patients. These omissions are problematic both for reasons of factual accuracy and because the two criteria they failed to acknowledge would likely mitigate rather than exacerbate racial disparities during triage.

Operating room time as a limited resource: ethical considerations for allocation.

Scheduling surgical procedures among operating rooms (ORs) is mistakenly regarded as merely a tedious administrative task. However, the growing demand for surgical care and finite hours in a day qualify OR time as a limited resource. Accordingly, the objective of this manuscript is to reframe the process of OR scheduling as an ethical dilemma of allocating scarce medical resources. Recommendations for ethical allocation of OR time-based on both familiar and novel ethical values-are provided for healthcare institutions and individual surgeons.

Relational ethical approaches to the COVID-19 pandemic.

Key ethical challenges for healthcare workers arising from the COVID-19 pandemic are identified: isolation and social distancing, duty of care and fair access to treatment. The paper argues for a relational approach to ethics which includes solidarity, relational autonomy, duty, equity, trust and reciprocity as core values. The needs of the poor and socially disadvantaged are highlighted. Relational autonomy and solidarity are explored in relation to isolation and social distancing. Reciprocity is discussed with reference to healthcare workers' duty of care and its limits. Priority setting and access to treatment raise ethical issues of utility and equity. Difficult ethical dilemmas around triage, do not resuscitate decisions, and withholding and withdrawing treatment are discussed in the light of recently published guidelines. The paper concludes with the hope for a wider discussion of relational ethics and a glimpse of a future after the pandemic has subsided.

The draw of the few: the challenge of crisis guidelines for extremely scarce resources.

The COVID-19 pandemic has focused considerable attention on crisis standards of care (CSCs). Most public CSCs at present are effective tools for allocating scarce but not uncommon resources (like ventilators and dialysis machines). However, a different set of challenges arise with regard to extremely scarce resources (ESRs), where the number of patients in need may exceed the availability of the intervention by magnitudes of hundreds or thousands. Using the allocation of extracorporeal membrane oxygenation machines as a case study, this paper argues for a different set of CSCs specifically for ESRs and explores four principles (transparency, uniformity, equity and impact) that should shape such guidelines.

What's yours is ours: waiving intellectual property protections for COVID-19 vaccines.

This paper gives an ethical argument for temporarily waiving intellectual property (IP) protections for COVID-19 vaccines. It examines two proposals under discussion at the World Trade Organization (WTO): the India/South Africa proposal and the WTO Director General proposal. Section I explains the background leading up to the WTO debate. Section II rebuts ethical arguments for retaining current IP protections, which appeal to benefiting society by spurring innovation and protecting rightful ownership. It sets forth positive ethical arguments for a temporary waiver that appeal to standing in solidarity and holding companies accountable. After examining built-in exceptions to existing agreements and finding them inadequate, the paper replies to objections to a temporary waiver and concludes, in section III, that the ethical argument for temporarily waiving IP protection for COVID-19 vaccines is strong.

Who will receive the last ventilator: why COVID-19 policies should not prioritise healthcare workers.

Policies promoted and adopted for allocating ventilators during the COVID-19 pandemic have often prioritised healthcare workers or other essential workers. While the need for such policies has so far been largely averted, renewed stress on health systems from continuing surges, as well as the experience of allocating another scarce resource-vaccination-counsel revisiting the justifications for such prioritisation. Prioritising healthcare workers may have intuitive appeal, but the ethical justifications for doing so and the potential harms that could follow require careful analysis. Ethical justifications commonly offered for healthcare worker prioritisation for ventilators rest on two social value criteria: (1) instrumental value, also known as the 'multiplier effect', which may preserve the ability of healthcare workers to help others, and (2) reciprocity, which rewards past usefulness or sacrifice. We argue that these justifications are insufficient to over-ride the common moral commitment to value each person's life equally. Institutional policies prioritising healthcare workers over other patients also violate other ethical norms of the healthcare professions, including the commitment to put patients first. Furthermore, policy decisions to prioritise healthcare workers for ventilators could engender or deepen existing distrust of the clinicians, hospitals and health systems where those policies exist, even if they are never invoked.

Fallacy of the last bed dilemma.

The COVID-19 pandemic highlights the relevance of adequate decision making at both public health and healthcare levels. A bioethical response to the demand for medical care, supplies and access to critical care is needed. Ethically sound strategies are required for the allocation of increasingly scarce resources, such as rationing critical care beds. In this regard, it is worth mentioning the so-called 'last bed dilemma'. In this paper, we examine this dilemma, pointing out the main criteria used to solve it and argue that we cannot face these ethical issues as though they are only a dilemma. A more complex ethical view regarding the care of COVID-19 patients that is focused on proportional and ordinary treatments is required. Furthermore, discussions and forward planning are essential because deliberation becomes extremely complex during an emergency and the physicians' sense of responsibility may be increased if it is faced only as a moral dilemma.

Ethical decision making during a healthcare crisis: a resource allocation framework and tool.

The COVID-19 pandemic has strained healthcare resources the world over, requiring healthcare providers to make resource allocation decisions under extraordinary pressures. A year later, our understanding of COVID-19 has advanced, but our process for making ethical decisions surrounding resource allocation has not. During the first wave of the pandemic, our institution uniformly ramped-down clinical activity to accommodate the anticipated demands of COVID-19, resulting in resource waste and inefficiency. In preparation for the second wave, we sought to make such ramp down decisions more prudently and ethically. We report the development of a tool that can be used to make fair and ethical decisions in times of resource scarcity. We formed an interprofessional team to develop and use this tool to ensure that a diverse range of stakeholder perspectives were represented in this development process. This team, called the clinical activity recovery team, established institutional objectives that were combined with well-established procedural values, substantive ethical principles and decision-making criteria by using a variation on the well-known accountability for reasonableness ethical framework. The result of this is a stepwise, semiquantitative, ethical decision tool that can be applied to resource allocation challenges in order to reach fair and ethically defensible decisions. This ethical decision tool can be applied in various contexts and may prove useful at both the institutional and the departmental level; indeed this is how it is applied at our centre. As the second wave of COVID-19 strains healthcare resources, this tool can help clinical leaders to make fair decisions.

What is common and what is different: recommendations from European scientific societies for triage in the first outbreak of COVID-19.

A public health emergency, as the COVID-19 pandemic, may lead to shortages of potentially life-saving treatments. In this situation, it is necessary, justifiable and proportionate to have decision tools in place to enable healthcare professionals to triage and prioritise access to those resources. An ethically sound framework should consider the principles of beneficence and fair allocation. Scientific Societies across Europe were concerned with this problem early in the pandemic and published guidelines to support their professionals and institutions. This article aims to compare triage policies from medical bodies across Europe, to characterise the process of triage and the ethical values, principles and theories that were proposed in different countries during the first outbreak of COVID-19.

Unweighted lotteries and compounding injustice: reply to Schmidt et al.

I argue that Schmidt et al, while correctly diagnosing the serious racial inequity in current ventilator rationing procedures, misidentify a corresponding racial inequity issue in alternative 'unweighted lottery' procedures. Unweighted lottery procedures do not 'compound' (in the relevant sense) prior structural injustices. However, Schmidt et al do gesture towards a real problem with unweighted lotteries that previous advocates of lottery-based allocation procedures, myself included, have previously overlooked. On the basis that there are independent reasons to prefer lottery-based allocation of scarce lifesaving healthcare resources, I develop this idea, arguing that unweighted lottery procedures fail to satisfy healthcare providers' duty to prevent unjust population-level health outcomes, and thus that lotteries weighted in favour of Black individuals (and others who experience serious health injustice) are to be preferred.

WHO's allocation framework for COVAX: is it fair?

The COVID-19 Vaccines Global Access Facility (COVAX) represents an unprecedented global collaboration facilitating the development and distribution of vaccines for COVID-19. COVAX pools and channels funds from state and non-state actors to promising vaccine candidates, and has started to distribute successful candidates to participating states. The WHO, one of the leaders of COVAX, recognised vaccine doses would initially be scarce, and therefore, prepared a two-staged allocation mechanism they considered fair. In the first stage, vaccine doses are distributed equally among participating countries, while in the second stage vaccine doses will be allocated according to a country's need. Ethicists have questioned whether this is the fairest distribution-they argue a country's need should be taken into account from the start and correspondingly, have proposed a framework that treats individuals with equal moral concern, aims to minimise harm and gives priority to the worst-off. In this paper, we seek to explore these concerns by comparing COVAX's allocation mechanism to a targeted allocation based on need. We consider which distribution would more likely maximise well-being and align with principles of equity. We conclude that although in theory, a targeted distribution in proportion to a country's need would be more morally justifiable, when political realities are taken into account, an equal distribution seems more likely to avert a greater number of deaths and reduce disparities.

COVID-19 pandemic, the scarcity of medical resources, community-centred medicine and discrimination against persons with disabilities.

This research aims to examine access to medical treatment during the COVID-19 pandemic for people living with disabilities. During the COVID-19 pandemic, the practical and ethical problems of allocating limited medical resources such as intensive care unit beds and ventilators became critical. Although different countries have proposed different guidelines to manage this emergency, these proposed criteria do not sufficiently consider people living with disabilities. People living with disabilities are therefore at a higher risk of exclusion from medical treatments as physicians tend to assume they have poor quality of life, whereas access to medical treatment should be based on several parameters, including clinical data and prognosis. However, the COVID-19 pandemic shifts the medical paradigm from person-centred medicine to community-centred medicine, challenging the main ethical theories. We reviewed the main guidelines and recommendations for resources allocation and examined their position toward persons with disabilities. Based on our findings, we propose criteria for not discriminating against people with disabilities in allocating resources. The shift from person-centred to community-centred medicine offers opportunities but also risks sacrificing the most vulnerable people. The principle of reasonable accommodation must always be considered to guarantee the rights of persons with disabilities.

Among equity and dignity: an argument-based review of European ethical guidelines under COVID-19.

BACKGROUND: Under COVID-19 pandemic, many organizations developed guidelines to deal with the ethical aspects of resources allocation. This study describes the results of an argument-based review of ethical guidelines developed at the European level. It aims to increase knowledge and awareness about the moral relevance of the outbreak, especially as regards the balance of equity and dignity in clinical practice and patient's care. METHOD: According to the argument-based review framework, we started our research from the following two questions: what are the ethical principles adopted by the ethical guidelines produced at the beginning of the COVID-19 outbreak related to resource allocation? And what are the practical consequences in terms of 'priority' of access, access criteria, management of the decision-making process and patient care? RESULTS: Twenty-two ethical guidelines met our inclusion criteria and the results of our analysis are organized into 4 ethical concepts and related arguments: the equity principle and emerging ethical theories; triage criteria; respecting patient's dignity, and decision making and quality of care. CONCLUSION: Further studies can investigate the practical consequences of the application of the guidelines described, in terms of quality of care and health care professionals' moral distress.

WHO guidance on ethics in outbreaks and the COVID-19 pandemic: a critical appraisal.

In 2016, following pandemic influenza threats and the 2014-2016 Ebola virus disease outbreaks, the WHO developed a guidance document for managing ethical issues in infectious disease outbreaks. In this article, we analyse some ethical issues that have had a predominant role in decision making in response to the current COVID-19 pandemic but were absent or not addressed in the same ways in the 2016 guidance document. A pandemic results in a health crisis and social and political crises both nationally and globally. The ethical implications of these global effects should be properly identified so that appropriate actions can be taken globally and not just in national isolation. Our analysis, which is a starting point to test the broader relevance of the 2016 WHO document that remains the only available guidance document applicable globally, concludes that the WHO guidance should be updated to provide reasoned and thoughtful comprehensive ethics advice for the sound management of the current and future pandemics.

Pandemic prioritarianism.

Prioritarianism pertains to the generic idea that it matters more to benefit people, the worse off they are, and while prioritarianism is not uncontroversial, it is considered a generally plausible and widely shared distributive principle often applied to healthcare prioritisation. In this paper, I identify social justice prioritarianism, severity prioritarianism and age-weighted prioritarianism as three different interpretations of the general prioritarian idea and discuss them in light of the effect of pandemic consequences on healthcare priority setting. On this analysis, the paper arrives at the following three conclusions: (1) that we have strong prioritarian reasons for special concern about the vulnerable and socially disadvantaged in reference to pandemic effects, (2) that severity of illness is an important factor in identifying the worse off in priority setting but that this must not over-ride the special priority to the socially disadvantaged and (3) that the maximisation rationale of the age-weighted view runs against the core prioritarian idea, and the age-weighted prioritarianism is thus unfitting as a prioritarian response to the COVID-19 case.