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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. [ABSTRACT FROM AUTHOR]

ABSTRACT This first part of this article critiques Sridhar Venkatapuram's conception of health as a capability. It argues that Venkatapuram relies on the problematic concept of dignity, implies that those who are unhealthy lack lives worthy of dignity (which seems politically incorrect), sets a low bar for health, appeals to metaphysically problematic thresholds, fails to draw clear connections between appealed-to capabilities and health, and downplays the importance/relevance of health functioning. It concludes by questioning whether justice entitlements should pertain to the capability for health versus health achievements, challenging Venkatapuram's claims about the strength of health entitlements, and demonstrating that the capabilities approach is unnecessary to address social determinants of health. [ABSTRACT FROM AUTHOR]

A common strategy in bioethics is to posit a prima facie case in favour of one policy, and to then claim that the burden of proof (that this policy should be rejected) falls on those with opposing views. If the burden of proof is not met, it is claimed, then the policy in question should be accepted. This article illustrates, and critically evaluates, examples of this strategy in debates about the sale of organs by living donors, human enhancement, and the precautionary principle. We highlight general problems with this style of argument, and particular problems with its use in specific cases. We conclude that the burden ultimately falls on decision-makers (i.e. policy-makers) to choose the policy supported by the best reasons. [ABSTRACT FROM AUTHOR]

After a history of neglect, bioethicists have recently turned their attention to the topic of infectious disease. In this paper we link bioethicists’ earlier neglect of infectious disease to their under-appreciation of the extent to which the problem of infectious disease is related to social factors and thus to questions of justice. We argue that a social causation of illness model – well-known to sociologists of medicine, but incompletely understood by bioethicists – will improve future bioethical analysis of issues related to infectious disease. By emphasising the relationships between social and economic structures of inequality and health, the social causation model provides a richer approach to ethical issues associated with infectious disease than the more commonly used biomedical model. [ABSTRACT FROM AUTHOR]

While UNESCO`s Universal Draft Declaration on Bioethics and Human Rights highlights appropriate ethical values, its principles are stated in absolute terms and conflict with one another. The Draft Declaration fails to sufficiently address the possibility of conflict between principles, and it provides no real guidance on how to strike a balance between them in cases where conflict occurs. The document's inadequate treatment of conflicting values is revealed by examination of cases where principles aimed at the promotion of autonomy and liberty conflict with those aimed at benefit maximization and harm minimization. I argue that liberty (and autonomy) may be less important in the context of health care than in other contexts, and I conclude by suggesting specific ways in which some of UNESCO's principles should be revised in order to better address the reality of conflicting values. [ABSTRACT FROM AUTHOR]

Bioethics apparently suffers from a misdistribution of research resources analogous to the‘10/90’ divide in medical research. Though infectious disease should be recognized as a topic of primary importance for bioethics, the general topic of infectious disease has received relatively little attention from the discipline of bioethics in comparison with things like abortion, euthanasia, genetics, cloning, stem cell research, and so on. The fact that the historical and potential future consequences of infectious diseases are almost unrivalled is one reason that the topic of infectious disease warrants more attention from bioethicists. The‘Black Death’ eliminated one third of the European population during the 14th Century; the 1918 flu killed between 20 and 100 million people; and, in the 20th Century smallpox killed perhaps three times more people than all the wars of that period. In the contemporary world, epidemics (of AIDS, multi-drug resistant tuberculosis, and newly emerging infectious diseases such as SARS) continue to have dramatic consequences. A second reason why the topic of infectious disease deserves further attention is that it raises difficult ethical questions of its own. While infected individuals can threaten the health of other individuals and society as a whole, for example, public health care measures such as surveillance, isolation, and quarantine can require the infringement of widely accepted basic human rights and liberties. An important and difficult ethical question asks how to strike a balance between the utilitarian aim of promoting public health, on the one hand, and libertarian aims of protecting privacy and freedom of movement, on the other, in contexts involving diseases that are– to varying degrees– contagious, deadly, or otherwise dangerous. Third, since their burden is most heavily shouldered by the poor (in developing countries), infectious diseases deeply involve issues of justice– which should be a central concern of ethics. I conclude by providing sociological and historical explanations of why the topic of infectious disease has not already received more attention from bioethicists. [ABSTRACT FROM AUTHOR]

The article introduces a series of articles on the bioethics of infectious diseases. The topics covered by the featured articles are vaccination policy, bioterrorism, and physicians' duties to treat patients with contagious diseases. Other ethical issues raised in relation to infectious diseases include drug resistance, stigmatization of and discrimination against infected groups or individuals, and developing countries' access to medicines.

Focuses on the issues addressed in the articles contained in the 2004 issue of "Developing World Bioethics" in the U.S. Ethical concerns on infectious diseases; Distribution of bioethics research resources; Incentives for pharmacological development; Focus of primary care delivery on addressing inequalities in health across several population groups.

This report of the WHO Working Group for Guidance on Human Challenge Studies in COVID-19 outlines ethical standards for COVID-19 challenge studies. It includes eight Key Criteria related to scientific justification, risk-benefit assessment, consultation and engagement, co-ordination of research, site selection, participant selection, expert review, and informed consent. The document aims to provide comprehensive guidance to scientists, research ethics committees, funders, policymakers, and regulators in deliberations regarding SARS-CoV-2 challenge studies by outlining criteria that would need to be satisfied in order for such studies to be ethically acceptable. [ABSTRACT FROM AUTHOR]