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Allocation of very scarce medical interventions such as organs and vaccines is a persistent ethical challenge. We evaluate eight simple allocation principles that can be classified into four categories: treating people equally, favouring the worst-off, maximising total benefits, and promoting and rewarding social usefulness. No single principle is sufficient to incorporate all morally relevant considerations and therefore individual principles must be combined into multiprinciple allocation systems. We evaluate three systems: the United Network for Organ Sharing points systems, quality-adjusted life-years, and (...) disability-adjusted life-years. We recommend an alternative system—the complete lives system—which prioritises younger people who have not yet lived a complete life, and also incorporates prognosis, save the most lives, lottery, and instrumental value principles. (shrink)

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Four ethical values — maximizing benefits, treating equally, promoting and rewarding instrumental value, and giving priority to the worst off — yield six specific recommendations for allocating medical resources in the Covid-19 pandemic: maximize benefits; prioritize health workers; do not allocate on a first-come, first-served basis; be responsive to evidence; recognize research participation; and apply the same principles to all Covid-19 and non–Covid-19 patients.

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Bioethicists influence practices and policies in medicine, science, and public health. However, little is known about bioethicists’ views. We recently surveyed 824 U.S. bioethicists on a wide range of ethical issues, including topics related to abortion, medical aid in dying, and resource allocation, among others. We also asked bioethicists about their demographic, religious, academic, and professional backgrounds. We find that bioethicists’ normative commitments predict their views on bioethical issues. We also find that, in important ways, bioethicists’ views do not align (...) with those of the U.S. public: for instance, bioethicists are more likely than members of the public to think abortion is ethically permissible but are less likely to believe compensating organ donors is. Our demographic results indicate the field of bioethics is far less diverse than the U.S. population—less diverse even than other academic disciplines—suggesting far more work needs to be done to build an inclusive field. (shrink)

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Glucagon-like peptide-1 (GLP-1) receptor agonists, such as semaglutide, and dual GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) receptor agonists, such as tirzepatide, have been found to be effective for treating obesity and diabetes, significantly reducing weight and the risk or predicted risk of adverse cardiovascular events. There is a global shortage of these medications that could last several years and raises questions about how limited supplies should be allocated. We propose a fair-allocation framework that enables evaluation of the ethics of current (...) practices and could guide governments, professional societies, and physicians in allocation decisions. (shrink)

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In this article, we propose the Fair Priority Model for COVID-19 vaccine distribution, and emphasize three fundamental values we believe should be considered when distributing a COVID-19 vaccine among countries: Benefiting people and limiting harm, prioritizing the disadvantaged, and equal moral concern for all individuals. The Priority Model addresses these values by focusing on mitigating three types of harms caused by COVID-19: death and permanent organ damage, indirect health consequences, such as health care system strain and stress, as well as (...) economic destruction. It proposes proceeding in three phases: the first addresses premature death, the second long-term health issues and economic harms, and the third aims to contain viral transmission fully and restore pre-pandemic activity. -/- To those who may deem an ethical framework irrelevant because of the belief that many countries will pursue "vaccine nationalism," we argue such a framework still has broad relevance. Reasonable national partiality would permit countries to focus on vaccine distribution within their borders up until the rate of transmission is below 1, at which point there would not be sufficient vaccine-preventable harm to justify retaining a vaccine. When a government reaches the limit of national partiality, it should release vaccines for other countries. -/- We also argue against two other recent proposals. Distributing a vaccine proportional to a country's population mistakenly assumes that equality requires treating differently situated countries identically. Prioritizing countries according to the number of front-line health care workers, the proportion of the population over 65, and the number of people with comorbidities within each country may exacerbate disadvantage and end up giving the vaccine in large part to wealthy nations. (shrink)

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This Viewpoint analyzes policies for covering GLP-1 receptor agonist drugs for obesity treatment across 13 high-income countries. It identifies four key lessons for developing coverage policies: 1) using up-to-date cost-effectiveness analyses that incorporate new evidence of benefits, 2) negotiating lower prices while preserving innovation incentives, 3) prioritizing coverage for specific populations rather than issuing blanket denials, and 4) treating obesity medications similarly to high-cost drugs for other conditions. It argues that blanket coverage denials are unethical and that countries should implement (...) targeted coverage policies that maximize benefits while managing costs. (shrink)

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Initial vaccine allocations for the coronavirus disease 2019 (COVID-19) will be limited. It is crucial to assess the ethical values associated with different methods of allocation, as well as important scientific and practical questions. This Viewpoint identifies three ethical values, benefiting people and limiting harm; prioritizing disadvantaged populations; and equal concern for all. It then explains why these values support prioritizing three groups: health care workers; other essential workers and people in high-transmission settings; and people with medical vulnerabilities associated with (...) poorer COVID-19 outcomes. In contrast, two other groups, people over 65 without medical vulnerabilities and participants in clinical research, present more complex ethical questions. This prioritization also encompasses valuing direct benefits to vaccinated individuals, indirect benefits to individuals protected from spread of infection, and indirect health and socioeconomic benefits to those protected from harm as health system and societal functioning improve. Vaccine allocation that recognizes important ethical values and avoids arbitrariness, waste, and corruption can ensure that the distribution of a COVID-19 vaccine is both fair and perceived as fair. (shrink)

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All parties involved in researching, developing, manufacturing, and distributing COVID-19 vaccines need guidance on their ethical obligations. We focus on pharmaceutical companies' obligations because their capacities to research, develop, manufacture, and distribute vaccines make them uniquely placed for stemming the pandemic. We argue that an ethical approach to COVID-19 vaccine production and distribution should satisfy four uncontroversial principles: optimising vaccine production, including development, testing, and manufacturing; fair distribution; sustainability; and accountability. All parties' obligations should be coordinated and mutually consistent. For (...) instance, companies should not be obligated to provide host countries with additional booster shots at the expense of fulfilling bilateral contracts with countries in which there are surges. Finally, any satisfactory approach should include mechanisms for assurance that all parties are honouring their obligations. This assurance enables countries, pharmaceutical companies, global organisations, and others to verify compliance with the chosen approach and protect ethically compliant stakeholders from being unfairly exploited by unethical behaviour of others. (shrink)

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During public health crises including the COVID-19 pandemic, resource scarcity and contagion risks may require health systems to shift—to some degree—from a usual clinical ethic, focused on the well-being of individual patients, to a public health ethic, focused on population health. Many triage policies exist that fall under the legal protections afforded by “crisis standards of care,” but they have key differences. We critically appraise one of the most fundamental differences among policies, namely the use of criteria to categorically exclude (...) certain patients from eligibility for otherwise standard medical services. We examine these categorical exclusion criteria from ethical, legal, disability, and implementation perspectives. Focusing our analysis on the most common type of exclusion criteria, which are disease-specific, we conclude that optimal policies for critical care resource allocation and the use of cardiopulmonary resuscitation (CPR) should not use categorical exclusions. We argue that the avoidance of categorical exclusions is often practically feasible, consistent with public health norms, and mitigates discrimination against persons with disabilities. (shrink)

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Health policy is only one part of social policy. Although spending administered by the health sector constitutes a sizeable fraction of total state spending in most countries, other sectors such as education and transportation also represent major portions of national budgets. Additionally, though health is one important aspect of economic and social activity, people pursue many other goals in their social and economic lives. Similarly, direct benefits—those that are immediate results of health policy choices—are only a small portion of the (...) overall impact of health policy. This chapter considers what weight health policy should give to its “spill-over effects,” namely non-health and indirect benefits. (shrink)

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This paper takes a novel approach to the active bioethical debate over whether advance medical directives have moral authority in dementia cases. Many have assumed that advance directives would lack moral authority if dementia truly produced a complete discontinuity in personal identity, such that the predementia individual is a separate individual from the postdementia individual. I argue that even if dementia were to undermine personal identity, the continuity of the body and the predementia individual’s rights over that body can support (...) the moral authority of advance directives. I propose that the predementia individual retains posthumous rights over her body that she acquired through historical embodiment in that body, and further argue that claims grounded in historical embodiment can sometimes override or exclude moral claims grounded in current embodiment. I close by considering how advance directives grounded in historical embodiment might be employed in practice and what they would and would not justify. (shrink)

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This correspondence piece responds to commentaries on the authors' survey of U.S. bioethicists. The authors address two key questions: the definition of a bioethicist and how bioethics should evolve. They identify four distinct roles bioethicists occupy: researchers, pedagogues, consultants, and advocates/activists. The article examines various aspects of inclusiveness in bioethics - demographic, viewpoint, methodological, and topical - while acknowledging inherent tensions and trade-offs between them. For example, including religiously or geographically diverse voices may conflict with other inclusivity goals. The authors (...) argue that while demographic inclusiveness is crucial, other forms of inclusiveness require careful consideration of trade-offs and empirical research to assess their impacts. They emphasize the need for systematic research on bioethicists' beliefs and reasoning, particularly regarding complex issues like disability and racial health disparities. The piece concludes by calling for continued dialogue and better funding for empirical research on ethical perspectives across different groups. (shrink)

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We propose six guideposts that states and hospitals should follow to respect disability rights when designing policies for the allocation of scarce, lifesaving medical treatments. Four relate to criteria for decisions. First, do not use categorical exclusions, especially ones based on disability or diagnosis. Second, do not use perceived quality of life. Third, use hospital survival and near-term prognosis (e.g., death expected within a few years despite treatment) but not long-term life expectancy. Fourth, when patients who use ventilators in their (...) daily lives (e.g., home ventilation) present to acute care hospitals, their personal ventilators should not be reallocated to other patients. Fifth, designate triage officers to assess patients individually on the basis of objective medical evidence, not stereotypes or assumptions. Sixth, include disability rights advocates in policy development and dissemination. (shrink)

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This article evaluates seven strategies for managing the high costs of GLP-1 receptor agonists (GLP-1RAs) like semaglutide and tirzepatide for weight management: complete exclusion of coverage, annual cost increase caps, lifetime cost caps, tiered access, formulary reevaluation, subscription payment models, and patent reform. The authors assess each strategy against three ethical objectives: benefiting people and preventing harm, showing equal moral concern, and mitigating disadvantage. Complete coverage exclusions, arbitrary reimbursement caps, and lifetime limits are deemed unethical as they fail to meet (...) these objectives. Tiering access based on relative benefit is considered justifiable, though current implementation often unfairly favors diabetes over obesity treatment. The authors recommend formulary reevaluation as the most ethical approach for smaller health plans, allowing them to prioritize more cost-effective treatments. For larger payers with market power and for governments, subscription payment models and patent reforms are potentially ethical solutions if implemented sustainably. The authors conclude that health plans should avoid ad hoc restrictions on GLP-1RAs in favor of comprehensive policy reforms that ensure sustainable access to these and future breakthrough treatments. (shrink)

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We argue that the ethical case for instituting vaccine benefit programs is justified by 2 widely recognized values: (1) reducing overall harm from COVID-19 and (2) protecting disadvantaged individuals. We then explain why they do not coerce, exploit, wrongfully distort decision-making, corrupt vaccination's moral significance, wrong those who have already been vaccinated, or destroy willingness to become vaccinated. However, their cost impacts and their effects on public perception of vaccines should be evaluated.

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Current challenges in medical practice, research, and administration demand physicians who are familiar with bioethics, health law, and health economics. Curriculum directors at American Association of Medical Colleges-affiliated medical schools were sent confidential surveys requesting the number of required hours of the above subjects and the years in which they were taught, as well as instructor names. The number of relevant publications since 1990 for each named instructor was assessed by a PubMed search.In sum, teaching in all three subjects combined (...) comprises less than two percent of the total hours in the American medical curriculum, and most instructors have not recently published articles in the fields they teach. This suggests that medical schools should reevaluate their curricula and instructors in bioethics, health law, and health economics. (shrink)

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By 20 October 2021, the U.S. Food and Drug Administration (FDA) had amended its Emergency Use Authorizations for immunocompetent adults who previously received the Pfizer-BioNTech, Moderna, or Johnson & Johnson COVID-19 vaccines. For the 2-dose Pfizer-BioNTech and Moderna vaccines, the FDA permitted a single booster dose for adults aged 65 years or older and adults aged 18 to 64 years at high-risk for severe COVID-19 or at high risk for occupational or institutional COVID-19 exposure. For the single-dose Johnson & Johnson (...) vaccine, the FDA permitted a single booster dose for all adults aged 18 or older. These eligibility schemes were endorsed by the Centers for Disease Control and Prevention shortly after FDA approval. (shrink)

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The COVID-19 pandemic has forced clinicians, policy-makers and the public to wrestle with stark choices about who should receive potentially life-saving interventions such as ventilators, ICU beds and dialysis machines if demand overwhelms capacity. Many allocation schemes face the question of whether to consider age. We offer two underdiscussed arguments for prioritising younger patients in allocation policies, which are grounded in prudence and fairness rather than purely in maximising benefits: prioritising one’s younger self for lifesaving treatments is prudent from an (...) individual perspective, and prioritising younger patients works to narrow health disparities by giving priority to patients at risk of dying earlier in life, who are more likely to be subject to systemic disadvantage. We then identify some confusions in recent arguments against considering age. (shrink)

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Recognising that offers of payment to research participants can serve various purposes—reimbursement, compensation and incentive—helps uncover differences between participants, which can justify differential payment of participants within the same study. Participants with different study-related expenses will need different amounts of reimbursement to be restored to their preparticipation financial baseline. Differential compensation can be acceptable when some research participants commit more time or assume greater burdens than others, or if inter-site differences affect the value of compensation. Finally, it may be permissible (...) to offer differential incentive payments if necessary to advance the goals of a study. We encourage investigators and Institutional Review Boards to think about whether to offer payment, in what amounts and for what purpose, and also to consider whether differential payment can help promote the scientific and ethical goals of clinical research. (shrink)

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The COVID-19 pandemic revealed numerous weaknesses in pandemic preparedness and response, including underfunding, inadequate surveillance, and inequitable distribution of countermeasures. To overcome these weaknesses for future pandemics, WHO released a zero draft of a pandemic treaty in February, 2023, and subsequently a revised bureau's text in May, 2023. COVID-19 made clear that pandemic prevention, preparedness, and response reflect choices and value judgements. These decisions are therefore not a purely scientific or technical exercise, but are fundamentally grounded in ethics. The latest (...) treaty draft reflects these ethical considerations by including a section entitled Guiding Principles and Approaches. Most of these principles are ethical—they establish core values that undergird the treaty. Unfortunately, the treaty draft's set of principles are numerous, overlapping, and show inadequate coherence and consistency. We propose two improvements to this section of the draft pandemic treaty. First, key guiding ethical principles should be clearer and more precise than they currently are. Second, the link between ethical principles and policy implementation should be clearly established and define boundaries on acceptable interpretation, ensuring that signatories abide by these principles. (shrink)

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Several quantitative surveys have been conducted internationally to gather empirical information about physicians’ general attitudes towards health care rationing. Are physicians ready to accept and implement rationing, or are they rather reluctant? Do they prefer implicit bedside rationing that allows the physician–patient relationship broad leeway in individual decisions? Or do physicians prefer strategies that apply explicit criteria and rules?

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Proposals for allocating scarce lifesaving resources in the face of the Covid-19 pandemic have aligned in some ways and conflicted in others. This paper attempts a kind of priority setting in addressing these conflicts. In the first part, we identify points on which we do not believe that reasonable people should differ—even if they do. These are (i) the inadequacy of traditional clinical ethics to address priority-setting in a pandemic; (ii) the relevance of saving lives; (iii) the flaws of first-come, (...) first-served allocation; (iv) the relevance of post-episode survival; (v) the difference between age and other factors that affect life-expectancy; and (vi) the need to avoid quality-of-life judgments. In the second part, we lay out some positions on which reasonable people can and do differ. These include (i) conflicts between maximizing benefits and priority to the worst off; (ii) role-based priority; and (iii) whether patients’ existing lifesaving resources should be subject to redistribution. (shrink)

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The COVID-19 pandemic has helped to clarify the fair and equitable allocation of scarce medical resources, both within and among countries. The ethical allocation of such resources entails a three-step process: (1) elucidating the fundamental ethical values for allocation, (2) using these values to delineate priority tiers for scarce resources, and (3) implementing the prioritisation to faithfully realise the fundamental values. Myriad reports and assessments have elucidated five core substantive values for ethical allocation: maximising benefits and minimising harms, mitigating unfair (...) disadvantage, equal moral concern, reciprocity, and instrumental value. These values are universal. None of the values are sufficient alone, and their relative weight and application will vary by context. In addition, there are procedural principles such as transparency, engagement, and evidence-responsiveness. Prioritising instrumental value and minimising harms during the COVID-19 pandemic led to widespread agreement on priority tiers to include health-care workers, first responders, people living in congregate housing, and people with an increased risk of death, such as older adults and individuals with medical conditions. However, the pandemic also revealed problems with the implementation of these values and priority tiers, such as allocation on the basis of population rather than COVID-19 burden, and passive allocation that exacerbated disparities by requiring recipients to spend time booking and travelling to appointments. This ethical framework should be the starting point for the allocation of scarce medical resources in future pandemics and other public health conditions. For instance, allocation of the new malaria vaccine among sub-Saharan African countries should be based not on reciprocity to countries that participated in research, but on maximally reducing serious illness and deaths, especially among infants and children. (shrink)

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This article proposes a novel strategy, one that draws on insights from antidiscrimination law, for addressing a persistent challenge in medical ethics and the philosophy of disability: whether health systems can consider quality of life without unjustly discriminating against individuals with disabilities. It argues that rather than uniformly considering or ignoring quality of life, health systems should take a more nuanced approach. Under the article's proposal, health systems should treat cases where quality of life suffers because of disability-focused exclusion or (...) injustice differently from cases where lower quality of life results from laws of nature, resource scarcity, or appropriate tradeoffs. Decisionmakers should ignore quality-of-life losses that result from injustice or exclusion when ignoring them would improve the prospects of individuals with disabilities; in contrast, they should consider quality-of-life losses that are unavoidable or stem from resource scarcity or permissible tradeoffs. On this proposal, while health systems should not amplify existing injustice against individuals with disabilities, they are not required to altogether ignore the potential effects of disability on quality of life. (shrink)

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We consider an ethical dilemma in global health: is it ethically acceptable to provide some patients cheaper treatments that are less effective or more toxic than the treatments other patients receive? We argue that it is ethical to consider local resource constraints when deciding what interventions to provide. The provision of cheaper, less effective health care is frequently the most effective way of promoting health and realizing the ethical values of utility, equality, and priority to the worst off.

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Recognizing that offers of payment to research participants can serve various purposes—reimbursement, compensation, and incentive—helps uncover differences between participants that can justify differential payment of participants within the same study. Participants with different study-related expenses will need different amounts of reimbursement to be restored to their pre-participation financial baseline. Differential compensation can be acceptable when some research participants commit more time or assume greater burdens than others, or if inter-site differences affect the value of compensation. Finally, it may be permissible (...) to offer differential incentive payments if necessary to advance a study’s goals. We encourage investigators and Institutional Review Boards to think not only about whether to offer payment, in what amounts, and for what purpose, but also to consider whether differential payment can help promote the scientific and ethical goals of clinical research. (shrink)

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Certifications of immunity are sometimes called “immunity passports” but are better conceptualized as immunity-based licenses. Such policies raise important questions about fairness, stigma, and counterproductive incentives but could also further individual freedom and improve public health. Immunity licenses should not be evaluated against a baseline of normalcy, ie, uninfected free movement. Rather, they should be compared to the alternatives of enforcing strict public health restrictions for many months or permitting activities that could spread infection, both of which exacerbate inequalities and (...) impose serious burdens. This Viewpoint presents a framework for analyzing the ethics of immunity licenses. (shrink)

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In this commentary, I critique three aspects of Emily Walsh's proposal to reduce the moral and legal weight of advance directives: (1) the ambiguity of its initial thesis, (2) its views about the ethics and legality of clinical practice, and (3) its interpretation and application of Ronald Dworkin’s account of advance directives and L.A. Paul's view on transformative experience. I also consider what Walsh’s proposal would mean for people facing the prospect of dementia. I conclude that our reasons to honor (...) many advance directives survive the move to a transformative experience framework. (shrink)

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Household debt has been widely discussed among social scientists, policy makers, and activists. Many have questioned the levels of debt households are required to take on, and have made various proposals for assisting households in debt. Yet theorists of distributive justice have left household debt underexamined. This article offers a normative examination of the distributive justice issues presented by proposals to relieve household debt or protect households from overindebtedness. I examine two goals at which debt relief proposals aim: remedying disadvantage (...) and stabilizing expectations. I then examine strategies for relieving existing debts such as debt abolition, forgiveness, bankruptcy, and mitigation, as well as strategies that aim to prevent future indebtedness, such as public provision or financing of costly goods and credit or interest rate regulations. (shrink)

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America’s COVID-19 pandemic has both devastated and disparately harmed minority communities. How can the allocation of scarce treatments for COVID-19 and similar public health threats fairly and legally respond to these racial disparities? Some have proposed that members of racial groups who have been especially hard-hit by the pandemic should receive priority for scarce treatments. Others have worried that this prioritization misidentifies racial disparities as reflecting biological differences rather than structural racism, or that it will generate mistrust among groups who (...) have previously been harmed by medical research. Still others complain that such prioritization would be fundamentally unjust. I argue that, to pass muster under current law, policymaking in this area must recognize a crucial distinction: prioritizing minority communities, such as hard-hit neighborhoods, without regard to individual race is typically legal, but prioritizing individuals on the basis of their racial identity faces is likely not. I also explain how prioritization on the basis of Native American status is allowable and legally distinct from prioritization on the basis of individual race. -/- In Part II, I provide a brief overview of current and proposed COVID-19 treatments and identify documented or likely scarcities and disparities in access. In Part III, I argue that randomly allocating scarce medical interventions, as some propose, will not effectively address disparities: it both permits unnecessary deaths and concentrates those deaths among people who are more exposed to infection. In Part IV, I explain why using individual-level racial classifications in allocation is precluded by current Supreme Court precedent. Addressing disparities will require focusing on factors other than race, or potentially considering race at an aggregate rather than individual level. I also argue that policies prioritizing members of Native American tribes can succeed legally even where policies based on race would not. In Part V, I examine two complementary strategies to narrow racial disparities. One would prioritize individuals who live in disadvantaged geographic areas or work in hard-hit occupations, potentially alongside race-sensitive aggregate metrics like neighborhood segregation. These approaches, like the policies school districts adopted after the Supreme Court rejected individualized racial classifications in education, would narrow disparities without classifying individuals by race. The other strategy would address the starkly disparate racial impact of deaths early in life by limiting the use of age-based exclusions from vaccine or treatment access that explicitly deprioritize the prevention of early deaths and so disparately exclude minorities, and by considering policies that prioritize the prevention of early deaths. (shrink)

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In infectious disease outbreaks, demand for certain medical resources often outstrips supply, necessitating frameworks to fairly allocate these now-scarce resources. Vaccination, meanwhile, can oft...

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Shortages of new therapeutics to treat coronavirus disease (COVID-19) have forced clinicians, public health officials, and health systems to grapple with difficult questions about how to fairly allocate potentially life-saving treatments when there are not enough for all patients in need (1). Shortages have occurred with remdesivir, tocilizumab, monoclonal antibodies, and the oral antiviral Paxlovid (2) -/- Ensuring equitable allocation is especially important in light of the disproportionate burden experienced during the COVID-19 pandemic by disadvantaged groups, including Black, Hispanic/Latino and (...) Indigenous communities, individuals with certain disabilities, and low-income persons. However, many health systems have resorted to first-come, first-served approaches to allocation, which tend to disadvantage individuals with barriers in access to care (3). There is mounting evidence of racial, ethnic, and socioeconomic disparities in access to medications for COVID-19 (4, 5). -/- One potential method to promote equitable allocation is to use a weighted lottery, which is an allocation strategy that gives all eligible patients a chance to receive the scarce treatment while also allowing the assignment of higher or lower chances according to other ethical considerations (6). We sought to assess the feasibility of implementing a weighted lottery to allocate scarce COVID-19 medications in a large U.S. health system and to determine whether the weighted lottery promotes equitable allocation. (shrink)

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This chapter discusses how justice applies to public health. It begins by outlining three different metrics employed in discussions of justice: resources, capabilities, and welfare. It then discusses different accounts of justice in distribution, reviewing utilitarianism, egalitarianism, prioritarianism, and sufficientarianism, as well as desert-based theories, and applies these distributive approaches to public health examples. Next, it examines the interplay between distributive justice and individual rights, such as religious rights, property rights, and rights against discrimination, by discussing examples such as mandatory (...) treatment and screening. The chapter also examines the nexus between public health and debates concerning whose interests matter to justice (the “scope of justice”), including global justice, intergenerational justice, and environmental justice, as well as debates concerning whether justice applies to individual choices or only to institutional structures (the “site of justice”). The chapter closes with a discussion of strategies, including deliberative and aggregative democracy, for adjudicating disagreements about justice. (shrink)

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When hospitals face surges of patients with COVID-19, fair allocation of scarce medical resources remains a challenge. Scarcity has at times encompassed not only hospital and intensive care unit beds—often reflecting staffing shortages—but also therapies and intensive treatments. Safe, highly effective COVID-19 vaccines have been free and widely available since mid-2021, yet many Americans remain unvaccinated by choice. Should their decision to forgo vaccination be considered when allocating scarce resources? Some have suggested it should, while others disagree. We offer a (...) framework for evaluating when it is ethical and briefly discuss its legality in American law. (shrink)

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This commentary examines the role of sustainability in the latest draft of the WHO pandemic accord, highlighting its notable absence from the official list of guiding principles despite being mentioned frequently throughout the text. It argues that sustainability should be explicitly acknowledged as a core principle and given a clear definition tailored to pandemic preparedness, and proposes defining sustainability as ensuring that immediate emergency responses don't compromise future pandemic preparedness and response capabilities. Including sustainability as a guiding principle would serve (...) two key purposes: validating the relevance of ethical principles in the accord's provisions and emphasizing the importance of long-term planning in pandemic preparedness. The commentary notes that while humans naturally discount future consequences, sustainable pandemic planning requires considering impacts beyond the next pandemic. It recommends coupling any reforms, such as intellectual property changes, with alternative innovation incentives to maintain a balanced approach to pandemic preparedness and response. (shrink)

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In our reply to critiques of our GLP-1 receptor agonist allocation framework, we explain that using potential years of life lost (PYLL) as a metric addresses racial health disparities without explicitly allocating resources based on race. This approach is "racism-conscious" and has legal and ethical challenges over race-based approaches. Meanwhile, though acknowledging the importance of cardiovascular risk assessment, we maintain in response to other interlocutors that focusing solely on immediate risk would ignore the broader goal of mitigating disadvantage. We emphasize (...) that our framework balances multiple ethical objectives beyond just maximizing medical benefits. (shrink)

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We argue that charging people to participate in research is likely to undermine the fundamental ethical bases of clinical research, especially the principles of social value, scientific validity, and fair subject selection.

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In an effort to contain the spread of COVID-19, many states and countries have adopted public health restrictions on activities previously considered commonplace: crossing state borders, eating indoors, gathering together, and even leaving one’s home. These policies often focus on specific activities or groups, rather than imposing the same limits across the board. In this Article, I consider the law and ethics of these policies, which I call tailored policies. In Part II, I identify two types of tailored policies--activity-based and (...) group-based. Activity-based restrictions respond to differences in the risks and benefits of specific activities, such as walking outdoors and dining indoors. Group-based restrictions consider differences between groups with respect to risk and benefit. Examples are policies that treat children or senior citizens differently, policies that require travelers to quarantine when traveling to a new destination, and policies that treat individuals differently based on whether they have COVID-19 symptoms, have tested positive for COVID-19, have previous COVID-19 infection, or have been vaccinated against COVID-19. In Part III, I consider the public health law grounding of tailored policies in the principles of “least restrictive means” and “well-targeting.” I also examine how courts have analyzed tailored policies that have been challenged on fundamental rights or equal protection grounds. I argue that fundamental rights analyses typically favor tailored policies and that equal protection does not preclude the use of tailored policies even when imperfectly crafted. In Part IV, I consider three critiques of tailored policies, centering on the claims that they produce inequity, cause harm, or unacceptably limit liberty. I argue that we must evaluate restrictions comparatively: the question is not whether tailored policies are perfectly equitable, wholly prevent harm, or completely protect liberty, but whether they are better than untailored ones at realizing these goals in a pandemic. I also argue that evaluation must consider indirect harms and benefits as well as direct and apparent ones. (shrink)

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Addressing distributive justice issues in health policy—ranging from the allocation of health system funding to the allocation of scarce COVID-19 interventions like intensive care unit beds and vaccines—involves the application of ethical principles. Should a principle of sustainability be among them? I suggest that while the value of temporal neutrality underlying such a principle is compelling, it is already implicit in the more basic principle of equal treatment. Munthe et al imagine sustainability accompanying four other principles: need, prognosis, equal treatment (...) and cost-effectiveness. Some are spelled out, however, in ways that are ambiguous or incomplete. (shrink)

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The coronavirus disease 2019 (COVID-19) pandemic has motivated medical ethicists and several task forces to revisit or issue new guidelines on allocating scarce medical resources. Such guidelines are relevant for the allocation of scarce therapeutics and vaccines and for allocation of ICU beds, ventilators, and other life-sustaining treatments or potentially scarce interventions. Principles underlying these guidelines, like saving the most lives, mitigating disparities, reciprocity to those who assume additional risk (eg, essential workers and clinical trial participants), and equal access may (...) compete with one another. We propose the use of a “categorized priority system” (also known as a “reserve system”) as an improvement over existing allocation methods, particularly because it may be able to achieve disparity mitigation better than other methods. (shrink)

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Consistent and well-designed frameworks for ethical oversight enable socially valuable research while forestalling harmful or poorly designed studies. I suggest some alterations that might strengthen the valuable checklist Rattani & Hyder propose for the ethical review of health policy and systems research (HPSR), or prompt future work in the area.

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Coronavirus disease 2019 can lead to respiratory failure. Some patients require extracorporeal membrane oxygenation support. During the current pandemic, health care resources in some cities have been overwhelmed, and doctors have faced complex decisions about resource allocation. We present a case in which a pediatric hospital caring for both children and adults seeks to establish guidelines for the use of extracorporeal membrane oxygenation if there are not enough resources to treat every patient. Experts in critical care, end-of-life care, bioethics, and (...) health policy discuss if age should guide rationing decisions. (shrink)

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This article examines a fundamental question of justice in global health. Is it ethically preferable to provide a larger number of people with cheaper treatments that are less effective (or more toxic), or to restrict treatments to a smaller group to provide a more expensive but more effective or less toxic alternative? We argue that choosing to provide less effective or more toxic interventions to a larger number of people is favored by the principles of utility, equality, and priority for (...) those worst-off. Advocates are mistaken to demand that medical care provided in low-income and middle-income countries should be the same as in high-income countries. (shrink)

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For much of 2021, allocating the scarce supply of Covid‐19 vaccines was the world's most pressing bioethical challenge, and similar challenges may recur for novel therapies and future vaccines. In the United States, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) identified three fundamental ethical principles to guide the process: maximize benefits, promote justice, and mitigate health inequities. We argue that critical components of the recommended protocol were internally inconsistent with these principles. Specifically, the ACIP (...) violated its principles by recommending overly broad health care worker priority in phase 1a, using being at least seventy‐five years of age as the only criterion to identify individuals at high risk of death from Covid‐19 during phase 1b, failing to recommend place‐based vaccine distribution, and implicitly endorsing first‐come, first‐served allocation. More rigorous empirical work and the development of a complete ethical framework that recognizes trade‐offs between principles may have prevented these mistakes and saved lives. (shrink)

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In this short response to Kerstein and Bognar, we clarify three aspects of the complete lives system, which we propose as a system of allocating scarce medical interventions. We argue that the complete lives system provides meaningful guidance even though it does not provide an algorithm. We also defend the investment modification to the complete lives system, which prioritizes adolescents and older children over younger children; argue that sickest-first allocation remains flawed when scarcity is absolute and ongoing; and argue that (...) Kerstein and Bognar are mistaken to base their allocation principles on differences in personhood. (shrink)

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In the United States, the Presidential Commission for the Study of Bioethical Issues has proposed deliberative democracy as an approach for dealing with ethical issues surrounding synthetic biology. Deliberative democracy might similarly help us as we update the regulation of human subjects research. This paper considers how the values that deliberative democratic engagement aims to realize can be realized in a human subjects research context. Deliberative democracy is characterized by an ongoing exchange of ideas between participants, and an effort to (...) justify decisions that bind participants by appeal to reasons that the participants can understand and share. Even when unanimous agreement is not reached, the active participation of everyone along with the requirement that reasons be made accessible enhances the legitimacy of the ultimate outcome. Importantly, deliberative democratic structures avoid strict hierarchies and place participants, as much as possible, in the position of equals. Human subjects research has some features that may make deliberative democratic principles seem initially unappealing. For one, there are asymmetries in knowledge between expert researchers conducting the research and participants in the research process. For another, statistical validity is made easiest by research paradigms that produce standardized, quantitative data, which can be difficult to achieve if research participants are given the power to deliberatively reshape the research design as it progresses. These and other problems have tended to produce a human subjects research process where subjects do not actively participate in shaping research, but rather consent to a predefined set of interventions designed by expert researchers and vetted by Institutional Review Boards (IRBs). In this paper, I suggest some ways in which human subjects research could do more to realize deliberative democratic values, and, in particular, how a revised Common Rule might help to realize these values. First, research participants could be treated not as passive subjects but instead involved in research design, ethical review, and the ongoing conduct and dissemination of research. Such participation might involve, for instance, including people who have served as research subjects on IRBs, or replacing IRB oversight for certain forms of research exempted from IRB oversight under a revised Common Rule with oversight by a body of community members or research subjects. It might also involve having the oversight of research that uses more participatory models be more participatory and less hierarchical in nature. I also raise questions about the exemption of research on public benefit programs from any research-level oversight and from consent requirements. While IRBs are likely not the correct overseers, there may be good reason to view such research with a critical eye, because of its potential for long-range impacts on the lives of participants. By giving research subjects a greater voice in research that aims at fine-tuning public benefit programs on which subjects rely, a deliberative oversight process has the potential to recast research participation as a form of active democratic participation and to address a “democratic deficit” in public health. Numerous proposals regarding health care have called for greater participation by laypeople and a more nonhierarchical approach to setting health priorities. Involving lay research subjects in the conduct of public benefits research and other forms of public health research may help to further these goals. (shrink)

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Technological and societal changes have made downward social and economic mobility a pressing issue in real-world politics. This article argues that a Rawlsian society would not provide any special protection against downward mobility, and would act rightly in declining to provide such protection. Special treatment for the downwardly mobile can be grounded neither in Rawls’s core principles—the basic liberties, fair equality of opportunity, and the difference principle—nor in other aspects of Rawls’s theory. Instead, a Rawlsian society is willing to sacrifice (...) particular individuals’ ambitions and plans for the achievement of justice, and offers those who lose out from justified change no special solicitude over and above the general solicitude extended to all. Rather than guaranteeing the maintenance of any particular individual or group’s economic position, it provides all of its members—the upwardly mobile, the downwardly mobile, and the immobile—a form of security that is at once more generous and more limited: that they will receive the liberties, opportunities, and resources promised by the principles of justice. (shrink)

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In this open peer commentary, we categorize the possible “neuroscience in national security” definitions of misuse of science and identify which, if any, are uniquely presented by advances in neuroscience. To define misuse, we first define what we would consider appropriate use: the application of reasonably safe and effective technology, based on valid and reliable scientific research, to serve a legitimate end. This definition presents distinct opportunities for assessing misuse: misuse is the application of invalid or unreliable science, or is (...) the use of reliable scientific methods to serve illegitimate ends. Ultimately, we conclude that while national security is often a politicized issue, assessing the state of scientific progress should not be. (shrink)

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Volume 25, Issue 1, January 2025, Page W3-W7.

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