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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]

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. [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]

Securitization of infectious diseases may involve suspension of ordinary human rights and liberties. In the event of an epidemic, therefore, it is important to limit the occasions upon which draconian disease control measures are implemented in the name of security. The term ‘security’, moreover, should not be used too loosely if it is to retain force and meaning in political discourse. It may be argued that the bar for disease securitization should be set high so that it is limited to contexts involving rapidly spreading pathogens. Such an approach, however, would rule out securitization of more slowly spreading, endemic diseases such as HIV/AIDS. An advantage of characterizing HIV/AIDS as a security threat in developing countries, where the burden of the disease is concentrated, is that this is likely to mobilize resources needed to improve the situation there. That is, if HIV/AIDS is convincingly framed as a security threat, then governments may recognize self-interested reasons to ramp up control measures. Following consideration of arguments for narrow (excluding HIV/AIDS) versus broad (including HIV/AIDS) conceptions of security, we conclude that the legitimacy of ‘securitizing’ HIV/AIDS ultimately turns on empirical and semantic issues, and we emphasize the importance of distinguishing (1) the nature of the threat posed by HIV/AIDS and (2) the measures required to address that threat. [ABSTRACT FROM AUTHOR]

This paper examines cumulative ethical and self-interested reasons why wealthy developed nations should be motivated to do more to improve health care in developing countries. Egalitarian and human rights reasons why wealthy nations should do more to improve global health are that doing so would (1) promote equality of opportunity, (2) improve the situation of the worst-off, (3) promote respect of the human right to have one’s most basic needs met, and (4) reduce undeserved inequalities in well-being. Utilitarian reasons for improving global health are that this would (5) promote the greater good of humankind, and (6) achieve enormous benefits while requiring only small sacrifices. Libertarian reasons are that this would (7) amend historical injustices and (8) meet the obligation to amend injustices that developed world countries have contributed to. Self-interested reasons why wealthy nations should do more to improve global health are that doing so would (9) reduce the threat of infectious diseases to developed countries, (10) promote developed countries’ economic interests, and (11) promote global security. All of these reasons count, and together they add up to make an overwhelmingly powerful case for change. Those opposed to wealthy government funding of developing world health improvement would most likely appeal, implicitly or explicitly, to the idea that coercive taxation for redistributive purposes would violate the right of an individual to keep his hard-earned income. The idea that this reason not to improve global health should outweigh the combination of rights and values embodied in the eleven reasons enumerated above, however, is implausibly extreme, morally repugnant and perhaps imprudent. [ABSTRACT FROM AUTHOR]

This paper reviews the dynamics behind, and ethical issues associated with, the phenomenon of drug resistance. Drug resistance is an important ethical issue partly because of the severe consequences likely to result from the increase in drug resistant pathogens if more is not done to control them. Drug resistance is also an ethical issue because, rather than being a mere quirk of nature, the problem is largely a product of drug distribution. Drug resistance results from the over-consumption of antibiotics by the wealthy; and it, ironically, results from the under-consumption of antibiotics, usually by the poor or otherwise marginalized. In both kinds of cases the phenomenon of drug resistance illustrates why health (care) – at least in the context of infectious disease – should be treated as a (global) public good. The point is that drug resistance involves ‘externalities’ affecting third parties. When one patient develops a resistant strain of disease because of her over- or under-consumption of medication, this more dangerous malady poses increased risk to others. The propriety of free-market distribution of goods subject to externalities is famously dubious – given that the ‘efficiency’ rationale behind markets assumes an absence of externalities. Market failure in the context of drug resistance is partly revealed by the fact that no new classes of antibiotics have been developed since 1970. I conclude by arguing that the case of drug resistance reveals additional reasons – to those traditionally appealed to by bioethicists – for treating health care as something special when making policy decisions about its distribution. [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]

This module examines ethical debates about the level of care that should be provided to human research participants. Particular attention is placed on the question of what should be considered an ethically acceptable control arm. You will also learn what relevant international and domestic regulatory documents say about standards of care. [ABSTRACT FROM AUTHOR]

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.