Human infection challenge studies (HCS) involve intentionally infecting research participants with pathogens (or other micro-organisms). There have been recent calls for more HCS to be conducted in low-income and middle-income countries (LMICs), where many relevant diseases are endemic. HCS in general, and HCS in LMICs in particular, raise numerous ethical issues. This paper summarises the findings of a project that explored ethical and regulatory issues related to LMIC HCS via (i) a review of relevant literature and (ii) 45 qualitative interviews (...) with scientists and ethicists. Among other areas of consensus, we found that there was widespread agreement that LMIC HCS can be ethically acceptable, provided that they have a sound scientific rationale, are accepted by local communities and meet usual research ethics requirements. Unresolved issues include those related to (i) acceptable approaches to trade-offs between the scientific aim to produce generalisable results and the protection of participants, (iii) the sharing of benefits with LMIC populations, (iii) the acceptable limits to risks and burdens for participants, (iv) the potential for third-party risk and whether the degree of acceptable third-party risk is different in endemic settings, (v) the conditions under which (if any) it would be appropriate to recruit children for disease-causing HCS, (v) appropriate levels of payment to participants and (vi) appropriate governance of (LMIC) HCS. This paper provides preliminary analyses of these ethical considerations in order to (i) inform scientists and policymakers involved in the planning, conduct and/or governance of LMIC HCS and (ii) highlight areas warranting future research. Insofar as this article focuses on HCS in (endemic) settings where diseases are present and/or widespread, much of the analysis provided is relevant to HCS (in HICs or LMICs) involving pandemic diseases including COVID19. (shrink)

Prepositions name spatial relationships. But they are also used to convey abstract, non-spatial relationships —raising the question of how the abstract uses relate to the concrete spatial uses. Despite considerable success in delineating these relationships, no general account exists for the two most frequently extended prepositions: in and on. We test the proposal that what is preserved in abstract uses of these prepositions is the relative degree of control between the located object and the reference object. Across four experiments, we (...) find a continuum of greater figure control for on and greater ground control for in. These findings bear on accounts of semantic structure and language change, as well as on second language instruction. (shrink)

Mass vaccination has been a successful public health strategy for many contagious diseases. The immunity of the vaccinated also protects others who cannot be safely or effectively vaccinated—including infants and the immunosuppressed. When vaccination rates fall, diseases like measles can rapidly resurge in a population. Those who cannot be vaccinated for medical reasons are at the highest risk of severe disease and death. They thus may bear the burden of others' freedom to opt out of vaccination. It is often asked (...) whether it is legitimate for states to adopt and enforce mandatory universal vaccination. Yet this neglects a related question: are those who opt out, where it is permitted, morally responsible when others are harmed or die as a result of their decision? In this article, we argue that individuals who opt out of vaccination are morally responsible for resultant harms to others. Using measles as our main example, we demonstrate the ways in which opting out of vaccination can result in a significant risk of harm and death to others, especially infants and the immunosuppressed. We argue that imposing these risks without good justification is blameworthy and examine ways of reaching a coherent understanding of individual moral responsibility for harms in the context of the collective action required for disease transmission. Finally, we consider several objections to this view, provide counterarguments and suggest morally permissible alternatives to mandatory universal vaccination including controlled infection, self-imposed social isolation and financial penalties for refusal to vaccinate. (shrink)

The global response to the recent coronavirus pandemic has revealed an ethical crisis in public health. This article analyses key pandemic public health policies in light of widely accepted ethical principles: the need for evidence, the least restrictive/harmful alternative, proportionality, equity, reciprocity, due legal process, and transparency. Many policies would be considered unacceptable according to pre-pandemic norms of public health ethics. There are thus significant opportunities to develop more ethical responses to future pandemics. This paper serves as the introduction to (...) this Special Issue of Monash Bioethics Review and provides background for the other articles in this collection. (shrink)

Controlled human infection challenge studies (CHIs) involve intentionally exposing research participants to, and/or thereby infecting them with, micro‐organisms. There have been increased calls for more CHIs to be conducted in low‐ and middle‐income countries (LMICs) where many relevant diseases are endemic. This article is based on a research project that identified and analyzed ethical and regulatory issues related to endemic LMIC CHIs via (a) a review of relevant literature and (b) qualitative interviews involving 45 scientists and ethicists with relevant expertise. (...) In this article we argue that though there is an especially strong case for conducting CHIs in endemic (LMIC) settings, certain ethical issues related to the design and conduct of such studies (in such settings) nonetheless warrant particularly careful attention. We focus on ethical implications of endemic LMIC CHIs regarding (a) potential direct benefits for participants, (b) risks to participants, (c) third‐party risks, (d) informed consent, (e) payment of participants, and (f) community engagement. We conclude that there is a strong ethical rationale to conduct (well‐designed) CHIs in endemic LMICs, that certain ethical issues warrant particularly careful consideration, and that ethical analyses of endemic LMIC CHIs can inform current debates in research ethics more broadly. (shrink)

Although every emerging infectious disease occurs in a unique context, the behaviour of previous pandemics offers an insight into the medium- and long-term outcomes of the current threat. Where an informative historical analogue exists, epidemiologists and policymakers should consider how the insights of the past can inform current forecasts and responses.

Drug‐resistant bacterial infections constitute a major threat to global public health. Several key bacteria that are becoming increasingly resistant are among those that are ubiquitously carried by human beings and usually cause no symptoms (i.e. individuals are asymptomatic carriers) until and/or unless a precipitating event leads to symptomatic infection (and thus disease). Carriers of drug‐resistant bacteria can also transmit resistant pathogens to others, thus putting the latter at risk of resistant infections. Accumulating evidence suggests that such transmission occurs not only (...) in hospital settings but also in the general community, although considerably more data are needed to assess the extent of this problem. Asymptomatic carriage of drug‐resistant bacteria raises important ethical questions regarding the appropriate public health response, including the degree to which it would be justified to impose burdens on asymptomatic carriers (and others) in order to prevent transmission. In this paper, we (i) summarize current evidence regarding the carriage of key drug‐resistant bacteria, noting important knowledge gaps; and (ii) explore the particular implications of existing public health ethics frameworks for policy‐making regarding asymptomatic carriers. Inter alia, we argue that the relative burdens imposed by public health measures on healthy carriers (as opposed to sick individuals) warrant careful consideration and should be proportionate to the expected public health benefits in terms of risks averted. We conclude that more surveillance and research regarding community transmission will be needed in order to clarify relevant risks and design proportionate policies, although extensive community surveillance itself would also require careful ethical consideration. (shrink)

The increasing emphasis on evidence-based clinical practice has thrown into sharp focus multiple deficiencies in current systems of ethical review. This paper argues that a complete overhaul of systems for ethical oversight of studies involving human subjects is now required as developments in medical, epidemiological and genetic research have outstripped existing structures for ethical supervision. It shows that many problems are now evident and concludes that sequential and piecemeal amendments to present arrangements are inadequate to address these. At their core (...) present systems of ethical review still rely on the integrity and judgment of individual investigators. One possible alternative is to train and license research investigators, make explicit their responsibilities and have ethics committees devote much more of their time to monitoring research activity in order to detect those infringing the rules. (shrink)

Zika virus was recognised in 2016 as an important vector-borne cause of congenital malformations and Guillain-Barré syndrome, during a major epidemic in Latin America, centred in Northeastern Brazil. The WHO and Pan American Health Organisation, with partner agencies, initiated a coordinated global response including public health intervention and urgent scientific research, as well as ethical analysis as a vital element of policy design. In this paper, we summarise the major ethical issues raised during the Zika epidemic, highlighting the PAHO ethics (...) guidance and the role of ethics in emergency responses, before turning to ethical issues that are yet to be resolved. Zika raises traditional bioethical issues related to reproduction, prenatal diagnosis of serious malformations and unjust disparities in health outcomes. But the epidemic has also highlighted important issues of growing interest in public health ethics, such as the international spread of infectious disease; the central importance of reproductive healthcare in preventing maternal and neonatal morbidity and mortality; diagnostic and reporting biases; vector control and the links between vectors, climate change, and disparities in the global burden of disease. Finally, there are controversies regarding Zika vaccine research and eventual deployment. Zika virus was a neglected disease for over 50 years before the outbreak in Brazil. As it continues to spread, public health agencies should promote gender equity and disease control efforts in Latin America, while preparing for the possibility of a global epidemic. (shrink)

Human infection challenge studies (HCS) have been proposed as a means to accelerate SARS-CoV2 vaccine development and thereby help to mitigate a prolonged global public health crisis. A key criterion for the ethical acceptability of SARS-CoV2 HCS is that potential benefits outweigh risks. Although the assessment of risks and benefits is meant to be a standard part of research ethics review, systematic comparisons are particularly important in the context of SARS-CoV2 HCS in light of the significant potential benefits and harms (...) at stake as well as the need to preserve public trust in research and vaccines. In this paper we explore several considerations that should inform systematic assessment of SARS-CoV-2 HCS. First, we detail key potential benefits of SARS-CoV-2 HCS including, but not limited to, those related to the acceleration of vaccine development. Second, we identify where modelling is needed to inform risk-benefit (and thus ethical) assessments. Modelling will be particularly useful in (i) comparing potential benefits and risks of HCS with those of vaccine field trials under different epidemiological conditions and (ii) estimating marginal risks to HCS participants in light of the background probabilities of infection in their local community. We highlight interactions between public health policy and research priorities, including situations in which research ethics assessments may need to strike a balance between competing considerations. (shrink)

Human infection challenge studies provide illuminating case studies for several ongoing debates in research ethics, including those related to research risks and payment of participants. Grimwade et al 1 add to previous public engagement, qualitative evidence and philosophical literature on these topics.1–8 The authors advocate revision of research payment policy and practice based on their main finding that members of the public endorse ex ante payment of participants proportional to research-related risk exposure, in addition to post hoc compensation for any (...) lasting harms that occur.1 Although ‘payment for risk’ would diverge from most current research ethics guidelines, it is noteworthy that the difference in payment to participants that their framework would allow might only be small, at least in the case of currently accepted studies. The absolute difference would likely be small because the risk of currently accepted HCS participation is usually very low.9 10 On a ‘value of statistical life’ approach, mirroring actuarial accounting for fatal risks, a 1 in 100 000 risk of death might attract an extra payment of only US$96.1 Most HCS do not involve fatality risks this high, although, on pessimistic estimates, the risk of COVID-19 HCS in young healthy adults might involve similar levels of risk.11 Such risks might arguably be justified by large expected public health benefits,12,9 11 13 but it remains controversial whether higher levels of payment could …. (shrink)

This Open Access volume provides in-depth analysis of the wide range of ethical issues associated with drug-resistant infectious diseases. Antimicrobial resistance is widely recognized to be one of the greatest threats to global public health in coming decades; and it has thus become a major topic of discussion among leading bioethicists and scholars from related disciplines including economics, epidemiology, law, and political theory. Topics covered in this volume include responsible use of antimicrobials; control of multi-resistant hospital-acquired infections; privacy and data (...) collection; antibiotic use in childhood and at the end of life; agricultural and veterinary sources of resistance; resistant HIV, tuberculosis, and malaria; mandatory treatment; and trade-offs between current and future generations. As the first book focused on ethical issues associated with drug resistance, it makes a timely contribution to debates regarding practice and policy that are of crucial importance to global public health in the 21st century. (shrink)

In 2022, students at North American universities with third-dose COVID-19 vaccine mandates risk disenrolment if unvaccinated. To assess the appropriateness of booster mandates in this age group, we combine empirical risk-benefit assessment and ethical analysis. To prevent one COVID-19 hospitalisation over a 6-month period, we estimate that 31 207–42 836 young adults aged 18–29 years must receive a third mRNA vaccine. Booster mandates in young adults are expected to cause a net harm: per COVID-19 hospitalisation prevented, we anticipate at least (...) 18.5 serious adverse events from mRNA vaccines, including 1.5–4.6 booster-associated myopericarditis cases in males (typically requiring hospitalisation). We also anticipate 1430–4626 cases of grade ≥3 reactogenicity interfering with daily activities (although typically not requiring hospitalisation). University booster mandates are unethical because they: (1) are not based on an updated (Omicron era) stratified risk-benefit assessment for this age group; (2) may result in a net harm to healthy young adults; (3) are not proportionate: expected harms are not outweighed by public health benefits given modest and transient effectiveness of vaccines against transmission; (4) violate the reciprocity principle because serious vaccine-related harms are not reliably compensated due to gaps in vaccine injury schemes; and (5) may result in wider social harms. We consider counterarguments including efforts to increase safety on campus but find these are fraught with limitations and little scientific support. Finally, we discuss the policy relevance of our analysis for primary series COVID-19 vaccine mandates. (shrink)

Pox parties are a controversial alternative to vaccination for diseases such as chickenpox. Such parties involve parents infecting non-immune children by exposing them to a contagious child. If successful, infection will usually lead to immunity, thus preventing infection later in life, which, for several vaccine-preventable diseases, is more severe than childhood infection. Some may consider pox parties more morally objectionable than opting out of vaccination through non-medical exemptions. In this paper, I argue that this is not the case. Pox parties (...) involve immediate risk of harm for children and reduce future harms, whereas opting out of vaccination places children at long-term risk of harms that increase with time, at least for some pathogens. Regarding harm to others through onward transmission of infection, this can be easily prevented in the case of pox parties—given the relatively controlled timing of infection—by quarantining attendees after the party, whereas opting out of vaccination involves risks to others that are more difficult to control. I defend three criteria for an ethical pox party: (1) that the disease is sufficiently low risk, (2) that parents consent to their child’s attendance and (3) that children exposed to infection are quarantined and isolated appropriately. I argue that, if these criteria are met, pox parties are morally preferable to non-vaccination; such parties involve less risk to non-consenting others and, for some pathogens in some cases, even involve less risk for the children who participate. Thus, policies that permit non-medical exemption to vaccination should also permit ethical pox parties. Alternatively, if pox parties are not permitted, then vaccination should be mandated for those without medical contraindication. (shrink)

COVID-19 poses an exceptional threat to global public health and well-being. Recognition of the need to develop effective vaccines at unprecedented speed has led to calls to accelerate research pathways ethically, including by conducting challenge studies ) with SARS-CoV-2. Such research is controversial, with concerns being raised about the social, legal, ethical and clinical implications of infecting healthy volunteers with SARS-CoV-2 for research purposes. Systematic risk evaluations are critical to inform assessments of the ethics of any proposed SARS-CoV-2 CHIs. Such (...) evaluations will necessarily take place within a rapidly changing and at times contested epidemiological landscape, in which differing criteria for the ethical acceptability of research risks have been proposed. This paper critically reviews two such criteria and evaluates whether the use of effective treatment should be a necessary condition for the ethical acceptability of SARS-CoV-2 CHIs, and whether the choice of study sites should be influenced by COVID-19 incidence levels. The paper concludes that ethical evaluations of proposed SARS-CoV-2 CHIs should be informed by rigorous, consultative and holistic approaches to systematic risk assessment. (shrink)

Moralization is a social-psychological process through which morally neutral issues take on moral significance. Often linked to health and disease, moralization may sometimes lead to good outcomes; yet moralization is often detrimental to individuals and to society as a whole. It is therefore important to be able to identify when moralization is inappropriate. In this paper, we offer a systematic normative approach to the evaluation of moralization. We introduce and develop the concept of ‘mismoralization’, which is when moralization is metaethically (...) unjustified. In order to identify mismoralization, we argue that one must engage in metaethical analysis of moralization processes while paying close attention to the relevant facts. We briefly discuss one historical example and two contemporary cases related to COVID-19 that we contend to have been mismoralized in public health. We propose a remedy of de-moralization that begins by identifying mismoralization and that proceeds by neutralizing inapt moral content. De-moralization calls for epistemic and moral humility. It should lead us to pull away from our tendency to moralize—as individuals and as social groups—whenever and wherever moralization is unjustified. (shrink)

Nipah virus is a priority pathogen that is receiving increasing attention among scientists and in work on epidemic preparedness. Despite this trend, there has been almost no bioethical work examining ethical considerations surrounding the epidemiology, prevention, and treatment of Nipah virus or research that has already begun into animal and human vaccines. In this paper, we advance the case for further work on Nipah virus disease in public health ethics due to the distinct issues it raises concerning communication about the (...) modes of transmission, the burdens of public health surveillance, the recent use of stringent public health measures during epidemics, and social or religious norms intersecting with preventive measures. We also advance the case for further work on Nipah virus disease in research ethics, given ethical issues surrounding potential vaccine trials for a high-fatality disease with sporadic spillover events, the different local contexts where trials may occur, and the potential use of unproven therapeutics during outbreaks. Further bioethics work may help to ensure that research and public health interventions for Nipah virus disease are ethically acceptable and more likely to be effective. (shrink)

In times of crises, public health leaders may claim that trials of public health interventions are unethical. One reason for this claim can be that equipoise—i.e. a situation of uncertainty and/or disagreement among experts about the evidence regarding an intervention—has been disturbed by a change of collective expert views. Some might claim that equipoise is disturbed if the majority of experts believe that emergency public health interventions are likely to be more beneficial than harmful. However, such beliefs are not always (...) justified: where high quality research has not been conducted, there is often considerable residual uncertainty about whether interventions offer net benefits. In this essay we argue that high-quality research, namely by means of well-designed randomized trials, is ethically obligatory before, during, and after implementing policies in public health emergencies (PHEs). We contend that this standard applies to both pharmaceutical and non-pharmaceutical interventions, and we elaborate an account of equipoise that captures key features of debates in the recent pandemic. We build our case by analyzing research strategies employed during the COVID-19 pandemic regarding drugs, vaccines, and non-pharmaceutical interventions; and by providing responses to possible objections. Finally, we propose a public health policy reform: whenever a policy implemented during a PHE is not grounded in high-quality evidence that expected benefits outweigh harms, there should be a planned approach to generate high-quality evidence, with review of emerging data at preset time points. These preset timepoints guarantee that policymakers pause to review emerging evidence and consider ceasing ineffective or even harmful policies, thereby improving transparency and accountability, as well as permitting the redirection of resources to more effective or beneficial interventions. (shrink)

[1] ʻAl ʻinyene ḥinukh ha-banim ṿeha-banot ṿi-yeme ha-baḥarut-- [2] ʻAl ʻinyene derekh ha-Ḥasidut lesayeaʻ le-zulato be-ruḥaniyut ṿe-nilṿeh elaṿ mikhteve ḳodesh be-ʻinyan zeh.

Die vorliegende Untersuchung zeigt, warum es vielversprechend ist, das Projekt einer kritischen Gesellschaftstheorie in der Tradition der Frankfurter Schule auf der Grundlage einer Theorie der Anerkennung durchzuführen. Die Kategorie der Anerkennung hat in diesem Zusammenhang besonderen Wert, weil sich mit ihr soziale Verhältnisse sowohl analysieren als auch kritisieren lassen. Als Anerkennungstheorie vermag die Kritische Theorie wesentliche Ziele in den Bereichen der Sozialtheorie und der Sozialkritik zu erreichen. Anhand einer neuen Interpretation einiger klassischer philosophischer und sozialwissenschaftlicher Texte zeigt die vorliegende Untersuchung, (...) warum Hegels Praktische Philosophie das Projekt einer kritischen Gesellschaftstheorie in der Tradition der Frankfurter Schule stärker bereichern kann, als bisher angenommen wurde. Darüber hinaus bietetdas Buch,,Anerkennung" als Prinzip der Kritischen Theorie eine gründliche Rekonstruktion und kritische Erörterung der anerkennungsbezogenen Überlegungen des jungen Marx. In ihr steht die Auseinandersetzung mit klassischen Texten unter systematischen Fragestellungen. (shrink)

a single life-span. Philosophers, then, do not see more or know more, and they do not see less or know less. They aim to see less detail and more of the abstract. Their details, if you like, are abstractions. Walking on God’s earth as a pedestrian, as a farmer working his fields or as a passer-by, one’s picture of one’s surroundings is every bit as intelligent as that of the pilot riding the sky. The views of the field are radically (...) different, however. One sees only a specific field and in all lively detail: the exact pattern of the land, or even the exact outline of a given leaf, grasshopper, grain of sand even. Acquaintance with minute detail is not without its price: details may stand in the way of conjuring the big picture. It may be difficult to compare whichever field one happens to be in with far off fields, with respect to their size or shape or any other quality. One may wish to inquire if far off fields were already planted, harvested, or even if they exist. A pedestrian may find it hard or even impossible to do so. The pedestrian view contains fine points that the pilot’s map never would, but it does not necessarily contain more information, for it lacks the general context. After all, there are only so many items that one can observe and account for at a single glance, a single map, a single book, a single life-span. (shrink)

Este número de acceso abierto tiene como objetivo resaltar los puntos de vista de los países latinoamericanos sobre la justicia en un contexto de pandemia y contribuir al diálogo entre estos y con la comunidad científica global. Explora los desafíos globales de la pandemia de COVID-19, las diferencias relevantes entre las medidas de salud pública y su impacto en los países de ingresos altos versus los países de ingresos bajos o medios, y cómo la injusticia global se profundizó debido a (...) la pandemia de COVID-19. También llama la atención sobre las experiencias, los resultados y las respuestas del norte global a la pandemia con respecto a poblaciones vulnerables y trayectorias de exposición que se reproducen en América Latina. (shrink)

This open-access issue aims to highlight views about justice in a pandemic context from Latin American countries and to contribute to the dialogue between them as well as with the global scientific community. It explores the global challenges of the COVID-19 pandemic, relevant differences between public health measures and their impact on high-income countries versus low- or middle-income countries, and how global injustice deepened because of the COVID-19 pandemic. It also draws attention to experiences, outcomes, and responses to the pandemic (...) from the global north regarding vulnerable populations and exposure paths that are also present in Latin America. (shrink)

Nach unserer Auffassung ist der Begriff der Arbeit als „das sich zum Dinge/Gegenstande machen" ein leistungsstarkes Konzept, auf dessen Grundlage in der Philosophie des Geistes von 1805/06 eine aus heutiger Sicht aufschlußreiche Analyse und Kritik der bürgerlichen Gesellschaft entwickelt wird. Der Nachweis dieser These ist der Gegenstand der vorliegenden Untersuchung. Zu diesem Zweck wird eine eingehende Analyse der diesbezüglich relevanten Textstellen aus der Philosophie des Geistes vorgenommen.

(1992). The rituals of science: Comments on Abir‐Am (with response) Social Epistemology: Vol. 6, The Historical Ethnography of Scientific Rituals, pp. 373-387.

A thorough academic discussion of Jordan Peterson’s work has been conspicuously absent—until now. Despite being addressed to an academic audience, Myth, Meaning, and Antifragile Individualism, by Marc Champagne, is written in a well-crafted, straightforward style accessible to the informed layperson. The book’s first part offers an invaluable introduction to Peterson’s work within an academic framework. The second part offers critiques of Peterson’s work, some of which are prudent and others of which are weaker. The book is an essential contribution to (...) anyone who wants to better understand Peterson’s ideas and scrutinize them in a rational context. (shrink)

In dem vorliegenden Beitrag rekonstruiere ich die linkslibertaristische Kritik des Rechts zu vererben, die Hillel Steiner ausgearbeitet hat, und prüfe, ob diese Kritik zufriedenstellend ist. Ich komme zu dem Ergebnis, dass Steiner in dem von ihm angelegten rechtstheoretischen Rahmen die von vielen Philosophen und Rechtswissenschaftlern angenommene rechtliche Gleichartigkeit des Vererbens und des Verschenkens mit überzeugenden Argumenten in Frage stellt, seinerseits aber das Recht zu vererben mit einer Theorie kritisiert, die gerechtigkeitstheoretische und sozialtheoretische Bedenken hervorruft. Wie ich abschließend darlege, geben die (...) erzielten Untersuchungsergebnisse Aufschluss über das ontologische Profil des Rechts zu vererben und die Eigentümlichkeit dieser Art der Eigentumsübertragung; sie eignen sich deshalb als Ausgangspunkt einer philosophischen Theorie des Erbrechts. (shrink)