Despite continuing controversies regarding the vital status of both brain-dead donors and individuals who undergo donation after circulatory death (DCD), respecting the dead donor rule (DDR) remains the standard moral framework for organ procurement. The DDR increases organ supply without jeopardizing trust in transplantation systems, reassuring society that donors will not experience harm during organ procurement. While the assumption that individuals cannot be harmed once they are dead is reasonable in the case of brain-dead protocols, we argue that the DDR (...) is not an acceptable strategy to protect donors from harm in DCD protocols. We propose a threefold alternative to justify organ procurement practices: (1) ensuring that donors are sufficiently protected from harm; (2) ensuring that they are respected through informed consent; and (3) ensuring that society is fully informed of the inherently debatable nature of any criterion to declare death. (shrink)

South Africa shared with the world the warning of a new strain of SARS-CoV2, Omicron, in November 2021. As a result, many high-income countries (HICs) instituted complete travel bans on persons leaving South Africa and other neighbouring countries. These bans were unnecessary from a scientific standpoint, and they ran counter to the International Health Regulations. In short, South Africa was penalized for sharing data. Data sharing during pandemics is commonly justified by appeals to solidarity. In this paper, we argue that (...) solidarity is, at best, an aspirational ideal to work toward but that it cannot ground an obligation to share data. Instead, low-and-middle income countries (LIMCs) should be guided by the principle of reciprocity, which states that we ought to return good for good received. Reciprocity is necessarily a conditional principle. LMICs, we argue, should only share data during future pandemics on the condition that HICs provide enforceable assurances that the benefits of data sharing will be equitably distributed and that LMICs won’t be penalized for sharing information. (shrink)

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)

Some organisations make vaccination a condition of employment. This means prospective employees must demonstrate they have been vaccinated (eg, against measles) to be hired. But it also means organisations must decide whether _existing_ employees should be expected to meet newly introduced vaccination conditions (eg, against COVID-19). Unlike prospective employees who will not be _hired_ if they do not meet vaccination conditions, existing employees who fail to meet new vaccination conditions risk being _fired_. The latter seems worse than the former. Hence, (...) objections to vaccination mandates commonly centre on the harms that will be visited on existing employees who are unwilling to be vaccinated. However, because this objection does not necessarily entail the claim that vaccination is unnecessary for the effective and safe performance of certain jobs, those making this objection should have less of an objection, or no objection at all (at least on these grounds), to introducing vaccination requirements in some cases for _prospective_ employees. Yet, in this paper, I shall argue that if one has reason to believe vaccination requirements can be justified for prospective employees, one should also believe they are justified for existing employees _despite_ any asymmetry in consequences experienced by the two groups. As a consequence, common objections made against vaccination mandates grounded solely in the harms that may be experienced by existing employees who are unwilling to be vaccinated should be considered unpersuasive. (shrink)

The most powerful lesson learned from the 2013-2016 outbreak of Ebola in West Africa was that we do not learn our lessons. A common sentiment at the time was that Ebola served as a “wake-up call”—an alarm which signalled that an outbreak of that magnitude should never have occurred and that we are ill-prepared globally to prevent and respond to them when they do. Pledges were made that we must learn from the outbreak before we were faced with another. Nearly (...) five years later the world is in the grips of a pandemic of the severe acute respiratory syndrome coronavirus 2 that causes coronavirus disease 2019. It is therefore of no surprise that we are now yet again hearing that the COVID-19 pandemic serves as the “wake-up call” we need and that there are many lessons to be learned to better prepare us for future outbreaks. Will anything be different this time around? We argue that nothing will fundamentally change unless we truly understand and appreciate the nature of the lessons we should learn from these outbreaks. Our past failures must be understood as moral failures that offer moral lessons. Unless we appreciate that we have a defect in our collective moral attitude toward remediating the conditions that precipitate the emergence of outbreaks, we will never truly learn. (shrink)

The exercise of identifying lessons in the aftermath of a major public health emergency is of immense importance for the improvement of global public health emergency preparedness and response. Despite the persistence of the Ebola Virus Disease outbreak in West Africa, it seems that the Ebola ‘lessons learned’ exercise is now in full swing. On our assessment, a significant shortcoming plagues recent articulations of lessons learned, particularly among those emerging from organizational reflections. In this article we argue that, despite not (...) being recognized as such, the vast majority of lessons proffered in this literature should be understood as ethical lessons stemming from moral failures, and that any improvements in future global public health emergency preparedness and response are in large part dependent on acknowledging this fact and adjusting priorities, policies and practices accordingly such that they align with values that better ensure these moral failures are not repeated and that new moral failures do not arise. We cannot continue to fiddle at the margins without critically reflecting on our repeated moral failings and committing ourselves to a set of values that engenders an approach to global public health emergencies that embodies a sense of solidarity and global justice. (shrink)

The intervention ladder, developed by the Nuffield Council on Bioethics, is a framework intended to help evaluate the ethical acceptability and justification of public health interventions according to their intrusion on liberty.1 In their recent article, Paetkau2 argues ‘the ladder obscures potential interventions that operate on a systemic rather than individual level’ (p. 1) and that ‘it is crucial that systemic interventions not be left off the table when considering potential concrete interventions’ (p. 3), leading them to propose instead the (...) ‘intervention stairway’. Yet, in this commentary we argue the intervention ladder does not delimit the sorts of public health interventions that may be considered to address a public health issue, although it may speak to their putative justification. Hence, despite its other considerable shortcomings,3 4 there is no need, as Paetkau argues, to broaden the intervention ladder to include systemic factors. Contrary to Paetkau’s claim, the intervention ladder does not preclude policymakers from considering systemic factors’ impact on health outcomes or the public health interventions and strategies that could be implemented to address them. Paetkau adduces the example of measures to protect patients, healthcare workers and healthcare capacity from the threat of infectious diseases. They argue that certain …. (shrink)

Systems thinking has emerged as a means of conceptualizing and addressing complex public health problems, thereby challenging more commonplace understanding of problems and corresponding solutions as straightforward explanations of cause and effect. Systems thinking tries to address the complexity of problems through qualitative and quantitative modeling based on a variety of systems theories, each with their own assumptions and, more importantly, implicit and unexamined values. To date, however, there has been little engagement between systems scientists and those working in bioethics (...) and public health ethics. The goal of this paper is to begin to consider what it might mean to combine systems thinking with public health ethics to solve public health challenges. We argue that there is a role for ethics in systems thinking in public health as a means of elucidating implicit assumptions and facilitating ethics debate and dialogue with key stakeholders. (shrink)

The ever‐increasing demand for organs led Spain, France, and other European countries to promote uncontrolled donation after circulatory determination of death (uDCDD). For the same reason, New York City has recently developed its own uDCDD protocol, which differs from European programs in some key ways. The New York protocol incorporates a series of technical and management improvements that address some practical problems identified in response to European uDCDD protocols. However, the more fundamental issue of whether uDCDD donors are dead when (...) organs are procured remains problematic for the New York City protocol and, indeed, for all uDCDD protocols. In the United States, two amendments to the legal criteria of death have been suggested to avoid a formal violation of the dead donor rule in DCDD protocols: first, replacing the requirement “irreversible” with the weaker term “permanent,” and second, using the term “circulatory” instead of “cardiac” to identify the key function that must be lost to declare death. While intended to facilitate controlled DCDD, these modifications create a problem for uDCDD protocols: if extracorporeal membrane oxygenation is introduced to preserve the organs, then circulation is restored after death is declared. In this issue of the Hastings Center Report, Kevin Munjal and colleagues call for a new ethical construct and policy so that uncontrolled and controlled DCDD can coexist. (shrink)

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)

Volume 20, Issue 9, September 2020, Page 41-44.

During the WHO-GloPID COVID-19 Global Research and Innovation Forum meeting held in Geneva on the 11th and 12th of February 2020 a number of different ethical concepts were used. This paper briefly states what a number of these concepts mean and how they might be applied to discussions about research during the COVID-19 pandemic and related outbreaks. This paper does not seek to be exhaustive and other ethical concepts are, of course, relevant and important.

The unprecedented outbreak of Ebola virus disease in West Africa has raised several novel ethical issues for global outbreak preparedness. It has also illustrated that familiar ethical issues in infectious disease management endure despite considerable efforts to understand and mitigate such issues in the wake of past outbreaks. To improve future global outbreak preparedness and response, we must examine these shortcomings and reflect upon the current state of ethical preparedness. To this end, we focus our efforts in this article on (...) the examination of one substantial area: ethical guidance in pandemic plans. We argue that, due in part to their focus on considerations arising specifically in relation to pandemics of influenza origin, pandemic plans and their existing ethical guidance are ill-equipped to anticipate and facilitate the navigation of unique ethical challenges that may arise in other infectious disease pandemics. We proceed by outlining three reasons why this is so, and situate our analysis in the context of the EVD outbreak and the threat posed by drug-resistant tuberculosis: different infectious diseases have distinct characteristics that challenge anticipated or existing modes of pandemic prevention, preparedness, response, and recovery, clear, transparent, context-specific ethical reasoning and justification within current influenza pandemic plans are lacking, and current plans neglect the context of how other significant pandemics may manifest. We conclude the article with several options for reflecting upon and ultimately addressing ethical issues that may emerge with different infectious disease pandemics. (shrink)

Health equity is increasingly identified as a principal goal to be achieved through public health policies and activities. However, what is to be measured in the assessment of health equity and how inequities in health ought to be redressed are among the pressing questions that must be answered if health equity is to serve as a meaningful and consistent ethical guide for measurement and intervention in public health. In this article I argue that the concept of health equity, in the (...) form it is predominantly found in public health, suffers from normative indeterminacy and is therefore unlikely to provide actionable normative guidance to public health policy-makers, practitioners and researchers. I argue that the concept of health equity, as it is commonly defined in public health, ultimately rests upon assumptions of a more fundamental, yet tacit, conception of justice to do its normative work. In this vein, I expand upon a critique of Margaret Whitehead’s oft-cited definition of health equity made by James Wilson to raise additional reasons not explored by Wilson, or others, as to why Whitehead’s definition remains inadequate in providing normative guidance to policy-makers, practitioners and researchers in public health. (shrink)

We live in an era where our health is linked to that of others across the globe, and nothing brings this home better than the specter of a pandemic. This paper explores the findings of town hall meetings associated with the Canadian Program of Research on Ethics in a Pandemic , in which focus groups met to discuss issues related to the global governance of an influenza pandemic. Two competing discourses were found to be at work: the first was based (...) upon an economic rationality and the second upon a humanitarian rationality. The implications for public support and the long-term sustainability of new global norms, networks, and regulations in global public health are discussed. (shrink)

The American Journal of Bioethics, Volume 12, Issue 6, Page 15-17, June 2012.

The American Journal of Bioethics, Volume 11, Issue 8, Page W4-W6, August 2011.

In his 2000 book, From Chaos to Coercion: Detention and the Control of Tuberculosis, Richard Coker makes a number of important observations and arguments regarding the use of coercive public health measures in response to infectious disease threats. In particular, Coker argues that we have a tendency to neglect public health threats and then demand immediate action, which can leave policymakers with fewer effective options and may require (or may be perceived as requiring) more aggressive, coercive measures to achieve public (...) health goals. While Coker makes a convincing case as to why we should find it ethically problematic when governments find themselves in this position and resort to coercion, left outstanding is the question of whether this should preclude governments and health authorities from using coercion if and when they do find themselves in this position. In this paper, I argue that, while we should consider it ethically objectionable when governments resort to coercion because they have neglected a public health threat, its causes, and other possible responses to that threat, this should not then necessarily rule out the use of coercion in such circumstances; that there are ethically objectionable antecedents for why coercion is being considered should not necessarily or automatically cause us to think coercion in such cases cannot be justified. I address an objection to this argument and draw several conclusions about how governments’ use of coercion in public health should be evaluated. (shrink)

Research conducted during epidemics may warrant adaptations or adaptive designs owing to practical constraints, time pressures, uncertainty, the importance of flexibility, and the potential for research to detract from epidemic response. Adapting research entails choosing different research designs or methods if research goals, contexts or constraints justify or require a different approach. Adaptive research, by contrast, is a type of research that prospectively plans for modifications after research has been initiated, while maintaining the validity and integrity of the research. While (...) adaptation and adaptive designs introduce an important degree of flexibility to research conducted during epidemics and help to address research objectives and constraints, adaptation and adaptive designs require close ethical scrutiny and are no different from other research in that they are expected to align with universally accepted ethical standards. Important ethical questions exist regarding the conditions that justify adaptations to research, the kinds of adaptive research designs that can be ethically justified, and how ethics review bodies ought to evaluate such novel approaches to research in epidemic contexts. The five cases included in this chapter prompt reflection on the ethical considerations and implications of adapting research in response to epidemic-related risks and the public health measures deployed in response to those risks, as well as the ethical implications of not adapting research in such contexts. These cases also highlight ethical questions and issues arising during the conduct of adaptive trials, including when treatments under study, treatment doses, sample size, and other study features are reviewed in response to evolving evidence. This chapter invites reflection on these key ethical dimensions when considering adaptive designs and adaptations to standard research procedures during epidemics. What these cases make clear is that adaptive designs and adaptations to research do not reduce the need for rigorous scientific evaluation and adherence to universal ethical standards, and must be explicitly ethically justified and reviewed through transparent and inclusive processes. (shrink)

Efforts to improve public health, both in the context of infectious diseases and non-communicable diseases, will often consist of measures that confer risk on some persons to bring about benefits to those same people or others. Still, it is unclear what exactly justifies implementing such measures that impose risk on some people and not others in the context of public health. Herein, we build on existing autonomy-based accounts of ethical risk imposition by arguing that considerations of imposing risk in public (...) health should be centered on a relational autonomy and relational justice approach. Doing so better captures what makes some risk permissible and others not by exploring the importance of power and context in such deliberations. We conclude the paper by applying a relational account of risk imposition in the cases of (a) COVID-19 measures and (b) the regulation of sugar-sweetened beverages to illustrate its explanatory power. (shrink)

Although there is no federal legislation yet on e-cigarettes, the U.S. Food and Drug Administration proposed regulations in April 2014 that would prohibit sales of e-cigarettes to anyone under eighteen and require that they be approved by the FDA as a tobacco product and carry warning labels for consumers on their packaging. Only three U.S. states have extended the same restrictions placed on tobacco products to e-cigarettes; however, eighteen states have passed legislation enacting use restrictions on venues such as schools, (...) state property, or workplaces. Until there is applicable legislation at the federal, state, or municipal levels, health care organizations will have to develop institutional policies if they wish to consistently address the use of e-cigarettes by patients and visitors on their property. (shrink)

This open access casebook addresses complex and important ethical challenges arising when health-related research in conducted in the context of epidemics and pandemics. This book provides contextually-rich real-world case studies illustrating research ethics issues encountered by researchers, ethics reviewers and regulators around the globe during the COVID-19 pandemic. The accompanying commentaries outline relevant conceptual approaches and ethical considerations. These promote understanding and reflection on relevant ethical issues, ethical approaches and competing considerations in a manner supporting thoughtful evaluation of their implications (...) for practice. As such the casebook is relevant to academic and professional audiences with an interest in global health, research ethics, and outbreaks and epidemics. (shrink)

Health regulators must carefully monitor the real-world safety and effectiveness of marketed vaccines through post-market monitoring in order to protect the public’s health and promote those vaccines that best achieve public health goals. Yet, despite the fact that vaccines used in collective immunization programmes should be assessed in the context of a public health response, post-market effectiveness monitoring is often limited to assessing immunogenicity or limited programmatic features, rather than assessing effectiveness across populations. We argue that post-market monitoring ought to (...) be expanded in two ways to reflect a ‘public health notion of post-market effectiveness’, which incorporates normative public health considerations: effectiveness monitoring should yield higher quality data and grant special attention to underrepresented and vulnerable populations; and the scope of effectiveness should be expanded to include a consideration of the various social factors that maximize a vaccine’s effectiveness at the population level, paying particular attention to how immunization programmes impact related health gradients. We use the case of the human papillomavirus vaccine in Canada to elucidate how expanding post-market effectiveness monitoring is necessary to close the gap between clinical practice and public health, and to ensure that vaccines are effective in a morally relevant sense. (shrink)

In democratic theory, “legitimacy” refers to the set of conditions that must be in place in order for the claims to authority of somebody to be deemed appropriate, and for their claims to compliance to be warranted. Though criteria of legitimacy have been elaborated in the context of democratic states, there is no reason for them not to be drawn up, with appropriate amendments, for other kinds of authority structures. This paper examines the claims to authority made over researchers by (...) international bodies governing research ethics, who exercise their authority by the research ethics guidelines they produce (including recent revisions to the Declaration of Helsinki and CIOMS Guidelines). We argue that discussions of such bodies and sets of guidelines often elide questions of justification and questions of legitimacy, and that the grounds that might allow us to mount a strong case for the latter are at present sorely underdeveloped. (shrink)

The primary aim of menu labelling should be understood as informing consumers such that they are better able to make informed food purchasing and consumption decisions; the extent to which consumers’ behaviours or, indeed, health outcomes, are affected may be contingent on several other factors and should therefore be considered more distal aims of what menu labelling intends to, or is able to, achieve. It is of importance to be clear about the nature and scope of menu labelling, including what (...) it might reasonably be expected to achieve, in order to elucidate the morally relevant equity considerations that ought to accompany the design and implementation of such interventions. This commentary attempts to begin to specify what these equity considerations ought to look like given the specific situational and dispositional factors associated with menu labelling. It concludes that the goals of menu labelling interventions should be, at a minimum, to strive to give consumers equality of access to nutrition information and/or the equal opportunity or capability to make informed food decisions in the eating out environment. These considerations support a universal approach to menu labelling, but may also require targeted strategies to attend to the needs of those less capable of making informed food decisions. (shrink)

Older age is one of the greatest risk factors for severe outcomes from COVID-19. If we believe it is important to use limited supplies of COVID-19 vaccines to protect the most vulnerable and prevent deaths, then available doses should be allocated with significant priority to older adults. Yet, we should resist the conclusion that age should be the sole criterion for COVID-19 vaccine prioritisation or that no younger populations (eg, those under the age of 60) should be prioritised until all (...) older adults have been vaccinated. This article examines arguments that are commonly presented to abandon ‘complex’ vaccine prioritisation schemes in favour of ‘just using age’ (eg, prioritising those 80 years of age and older and then decreasing in a 5-year age bands until the entire population has had the opportunity to be vaccinated), and articulates the ethical reasons why these arguments are not persuasive. (shrink)

IntroductionThe value of a short life characterized by disability has been hotly debated in the literature on fetal and neonatal outcomes.MethodsWe conducted a scoping review to summarize the available empirical literature on the experiences of families in the context of trisomy 13 and 18 (T13/18) with subsequent thematic analysis of the 17 included articles.FindingsThemes constructed include (1) Pride as Resistance, (2) Negotiating Normalcy and (3) The Significance of Time.InterpretationOur thematic analysis was guided by the moral experience framework conceived by Hunt (...) and Carnevale (2011) in association with the VOICE (Views On Interdisciplinary Childhood Ethics) collaborative research group.RelevanceThis article will be of interest and value to healthcare professionals and bioethicists who support families navigating the medically and ethically complex landscape of T13/18. (shrink)