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 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 to choose the policy supported by the best reasons. (shrink)

Although smallpox was declared eradicated in 1980, there are fears that stocks of the virus manufactured for military purposes by the Soviet Union may have fallen into the hands of “rogue nations” or terrorists. Worries about bioterrorism have thus sparked debate about whether or not the smallpox vaccine, which can be dangerous, should be offered to the general public. Meaningful public debate on this issue requires expert information about the likelihood that the virus will in fact be used as a (...) weapon. Informed voluntary individual decision making, about whether to get vaccinated if vaccine is made available to the public, would similarly require appreciation of the likelihood of attack. Public deliberation and private deliberation thus both require briefing by the intelligence community. (shrink)

The American Medical Association's Council on Ethical and Judicial Affairs' new “Guidelines to Prevent the Malevolent Use of Biomedical Research” are both timely and appropriate. These guidelines are a product of the increasing realization of the “dual use” potential of life science discoveries. Although biomedical research usually aims at the development of new medicines, vaccines, diagnostics, and so on, the very same discoveries that could benefit humankind in these ways also often have implications for the development of biological weapons. The (...) CEJA Guidelines draw attention to this fact and hold that physician–researchers have responsibilities regarding the uses to which their discoveries are put. Medical researchers should assess the likely social benefits and harms of their work and avoid projects where the latter outweigh the former. Knowledge and the advancement of science should not be the only aims of scientists; “commitment to public welfare and safety” are also essential. Toward the aim of preventing the malevolent use of research discoveries, the CEJA states that “regulatory oversight” of research, increased ethics education of physician researchers, and sometimes perhaps even censorship of research findings, are warranted. (shrink)

Centre for Applied Philosophy and Public Ethics, The Australian National University, LPO Box 8260, ANU, Canberra ACT 2601, Australia. Email: michael.selgelid{at}anu.edu.au ' + u + '@ ' + d + ' '/ /- ->. Home page: http: //www.cappe.edu.au/staff/michael-selgelid.htmThis article advocates the development of a moderate pluralist theory of political philosophy that recognizes that utility, liberty and equality are legitimate, independent social values and that none should have absolute priority over the others. Inter alia, such a theory would provide (...) a principled means for striking a balance, or making trade-offs, between these values in cases of conflict. Recent developments in public health ethics have made progress in thinking about how to make trade-offs between liberty and utility in particular. While public health ethicists often claim that the least restrictive alternative should be used to achieve the public health goal in question, I argue that a plausible but under-recognized idea is that the least restrictive alternative might sometimes involve improvement of global health via redistributive taxation—i.e., rather than coercive social distancing measures. I conclude by demonstrating that the proportionality principle leaves open the question of when exactly utility outweighs liberty or vice versa—and I argue that, rather than speaking about the morality of liberty-infringing public health interventions in categorical/binary terms, it would be more fruitful and realistic to think and speak about the degree to which a liberty-infringing public health intervention is morally appropriate. CiteULike Connotea Del.icio.us What's this? (shrink)

This seminal collection on the ethical issues associated with infectious disease is the first book to correct bioethics’ glaring neglect of this subject. Timely in view of public concern about SARS, AIDS, avian flu, bioterrorism and antibiotic resistance. Brings together new and classic papers by prominent figures. Tackles the ethical issues associated with issues such as quarantine, vaccination policy, pandemic planning, biodefense, wildlife disease and health care in developing countries.

AIDS in the Twenty‐First Century: Disease and Globalization, by Tony Barnett and Alan Whiteside. New York: Palgrave Macmillan. 2002. 416 pp. US$19.95 The Moral Economy of AIDS in South Africa, by Nicoli Nattrass. Cambridge, UK: Cambridge University Press. 2004. 222 pp. US$30.00.

CAPPE LPO Box 8260 ANU Canberra ACT 2601 Australia Tel: +61 (0)2 6125 4355, Fax: +61 (0)2 6125 6579; Email: michael.selgelid{at}anu.edu.au ' + u + '@' + d + ' '//--> Abstract This article reviews ethically relevant history of tuberculosis and recent developments regarding extensively drug resistant tuberculosis (XDR-TB). It argues that tuberculosis is one of the most important neglected topics in bioethics. With an emphasis on XDR-TB, it examines a range of the more challenging ethical issues associated with (...) tuberculosis: individual obligations to avoid infecting others, coercive social distancing measures, third-party notification, health workers' duty to treat contagious patients, and international justice. In each of these cases, key philosophical questions are highlighted and the need for empirical research/information is demonstrated. CiteULike Connotea Del.icio.us What's this? (shrink)

Though the reputation of eugenics has been tarnished by history, eugenics per se is not necessarily a bad thing. Many advocate a liberal new eugenics—where individuals are free to choose whether or not to employ genetic technologies for reproductive purposes. Though genetic interventions aimed at the prevention of severe genetic disorders may be morally and socially acceptable, reproductive liberty in the context of enhancement may conflict with equality. Enhancement could also have adverse effects on utility. The enhancement debate requires a (...) shift in focus. What the equality and/or utility costs of enhancement will be is an empirical question. Rather than philosophical speculation, more social science research is needed to address it. Philosophers, meanwhile, should address head-on the question of how to strike a balance between liberty, equality, and utility in cases of conflict (in the context of genetics). (shrink)

ABSTRACT 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. (shrink)

The dual-use dilemma arises in the context of research in the biological and other sciences as a consequence of the fact that one and the same piece of scientific research sometimes has the potential to be used for bad as well as good purposes. It is an ethical dilemma since it is about promoting good in the context of the potential for also causing harm, e.g., the promotion of health in the context of providing the wherewithal for the killing of (...) innocents. It is an ethical dilemma for the researcher because of the potential actions of others, e.g., malevolent non-researchers who might steal dangerous biological agents, or make use of the original researcher’s work. And it is a dilemma for governments concerned with the security of their citizens, as well as their health. In this article we construct a taxonomy of types of “experiments of concern” in the biological sciences, and thereby map the terrain of ethical risk. We then provide a series of analyses of the ethical problems and considerations at issue in the dual-use dilemma, including the impermissibility of certain kinds of research and possible restrictions on dissemination of research results given the risks to health and security. Finally, we explore the main available institutional responses to some of the specific ethical problems posed by the dual-use dilemma in the biological sciences. (shrink)

Gain-of-function research involves experimentation that aims or is expected to increase the transmissibility and/or virulence of pathogens. Such research, when conducted by responsible scientists, usually aims to improve understanding of disease causing agents, their interaction with human hosts, and/or their potential to cause pandemics. The ultimate objective of such research is to better inform public health and preparedness efforts and/or development of medical countermeasures. Despite these important potential benefits, GOF research can pose risks regarding biosecurity and biosafety. In 2014 the (...) administration of US President Barack Obama called for a “pause” on funding of GOF experiments involving influenza, SARS, and MERS viruses in particular. With announcement of this pause, the US Government launched a “deliberative process” regarding risks and benefits of GOFR to inform future funding decisions—and the US National Science Advisory Board for Biosecurity was tasked with making recommendations to the US Government on this matter. As part of this deliberative process the National Institutes of Health commissioned this Ethical Analysis White Paper, requesting that it provide review and summary of ethical literature on GOFR, identification and analysis of existing ethical and decision-making frameworks relevant to the evaluation of risks and benefits of GOFR, decision-making about the conduct of GOF studies, and the development of US policy regarding GOFR, and development of an ethical and decision-making framework that may be considered by NSABB when analyzing information provided by GOFR risk-benefit assessment, and when crafting its final recommendations. The ethical and decision-making framework ultimately developed is based on the idea that there are numerous ethically relevant dimensions upon which any given case of GOFR can fare better or worse : research imperative, proportionality, minimization of risks, manageability of risks, justice, good governance, evidence, and international outlook and engagement. Rather than drawing a sharp bright line between GOFR studies that are ethically acceptable and those that are ethically unacceptable, this framework is designed to indicate where any given study would fall on an ethical spectrum—where imaginable cases of GOFR might range from those that are most ethically acceptable, at one end of the spectrum, to those that are most ethically problematic or unacceptable, at the other. The aim should be that any GOFR pursued should be as far as possible towards the former end of the spectrum. (shrink)

Centre for Applied Philosophy and Public Ethics (CAPPE), Menzies Centre for Health Policy, The Australian National University, LPO Box 8260, ANU Canberra ACT 2601, Australia. Tel.: +61 (0)2 6125 4355; Mobile: +61 (0)431 124 286; Fax: +61 (0)2 6125 6579; Email: michael.selgelid{at}anu.edu.au ' + u + '@' + d + ' '//--> Abstract Thomas Pogge has proposed a supplement to the standard patent regime whereby innovating companies would be rewarded in proportion to the extent to which their innovations lead (...) to reduction of the global burden of disease (GBD). This paper argues that an expansion of this proposal—whereby provision of already existing medicines are incentivised in a similar way—would provide a more comprehensive solution to the healthcare situation in developing countries. It then considers the practical challenges that the implementation of such a proposal (expanded or otherwise) would entail. Though these include difficulties associated with disease burden metric, I argue that the most serious difficulties are associated with the problem of causal attribution. A basic idea underlying Pogge's proposal is that the disease burden reduction attributable to particular interventions can be determined. Theoretically speaking, in cases involving multiple interacting causal factors, there may be no fact of the matter regarding the extent to which disease burden reduction should be attributed to one intervention as opposed to another; and (even if workable practical solutions to this theoretical challenge can be met) the data requirements for implementation would be daunting. CiteULike Connotea Del.icio.us What's this? (shrink)

In debates over the regulation of communication related to dual-use research, the risks that such communication creates must be weighed against against the value of scientific autonomy. The censorship of such communication seems justifiable in certain cases, given the potentially catastrophic applications of some dual-use research. This conclusion however, gives rise to another kind of danger: that regulators will use overly simplistic cost-benefit analysis to rationalize excessive regulation of scientific research. In response to this, we show how institutional design principles (...) and normative frameworks from free speech theory can be used to help extend the argument for regulating dangerous dual-use research beyond overly simplistic cost-benefit reasoning, but without reverting to an implausibly absolutist view of scientific autonomy. (shrink)

This chapter contains sections titled: The Ethical Importance of Infectious Disease The Global Infectious Disease Status Quo: AIDS and TB Drug Resistance Limiting Liberty in Contexts of Contagion Improving Global Health References Further reading.

This issue of Journal of Medical Ethics includes a pair of papers debating the implications of moral bioenhancement for human freedom–and, especially, the question of whether moral enhancement should potentially be compulsory. In earlier writings Ingmar Persson and Julian Savulescu argue that compulsory moral bioenhancement may be necessary to prevent against catastrophic harms that might result from immoral behaviour.1 In “Voluntary moral enhancement and the survival-at-any-cost bias” Vojin Rakic agrees with P&S that moral bioenhancement is important, but he argues that (...) bioenhancement interventions should be voluntary rather than compulsory .Both Rakic and P&S disagree with Harris, who denies that moral enhancement could involve interventions beyond cognitive enhancement. Moral enhancement would essentially involve cognitive enhancement, according to Harris, because moral behaviour requires ability to distinguish right from wrong–ie, awareness and rational capacity.2 While Harris admits that those who know what is right might not always do what is right, he argues that we could not altogether prevent people from doing what is wrong without destroying freedom essential to their moral agency.According to Rakic, however, the fact that people who know what is right might not always do what is right reveals that mere cognitive enhancement would be inadequate to prevent immoral behavior–because much immoral behaviour results from weakness of will. Because people could freely chose to undergo moral enhancement, furthermore, according to Rakic, “our freedom will not be curtailed by it”. Presumably Rakic here supposes that if a person freely choses to be in State A then State A is necessarily compatible with–and a reflection of–her human freedom. Forcing a person to be in State A, on the other hand, …. (shrink)

In this article, we raise ethical concerns about the potential misuse of open-source biology : biological research and development that progresses through an organisational model of radical openness, deskilling, and innovation. We compare this organisational structure to that of the open-source software model, and detail salient ethical implications of this model. We demonstrate that OSB, in virtue of its commitment to openness, may be resistant to governance attempts.

The qualitative research of Baum and colleagues (2009), among other things, reveals that people are worried about the financial consequences of social-distancing measures and that lack of trust in...

The proliferation of prenatal genetic testing likely to follow from advances in genetic science invites reconsideration of the moral status of abortion. In this article I examine arguments surrounding the moral status of the fetus. I conclude that secular philosophy should ultimately admit that the moral status of the fetus is uncertain, and that this uncertainty itself makes abortion morally problematic. While this does not imply that abortion is always morally wrong or that it should be legally prohibited, it does (...) recommend a presumption in favor of preserving fetal life except in special circumstances. A relevant worry is that the rise of eugenic abortion gives new force to slippery slope arguments that we will be led down a path to a situation where more fetuses are terminated for relatively trivial reasons and that this will promote other bad social consequences. This might justify legislative discouragement of certain genetic interventions. (shrink)

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. (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)

This article reviews the history of smallpox and ethical issues that arise with its threat as a biological weapon. Smallpox killed more people than any infectious disease in history-and perhaps three times more people in the 20th Century than were killed by all the wars of that period. Following a WHO-sponsored global vaccination campaign, smallpox was officially declared eradicated in 1980. It has since been revealed that the Soviet Union, until its fall in the early 1990s, manufactured tens of tons (...) of smallpox for military purposes. A worry is that some of this may have fallen into the hands of "rogue" nations or terrorists. Current U.S. debate questions whether smallpox vaccine should therefore be made available to the American public, which-like the rest of the world-now lacks immunity. Because the vaccine is considerably dangerous, public dialogue cannot resolve this matter if evidence material to the likelihood of attack is classified (i.e. secret). I conclude by recommending numerous future areas for ethics research related to the weaponization of smallpox. (shrink)

Because a newborn baby does not have sufficiently complex psychological capacities to have a concept of continuation of life, according to Tooley, it cannot desire continuation of life, and thus cannot have a right to it.1 A similar position has been advocated by Kuhse and Singer2 ,3—and, more recently, by Giubilini and Minerva.4Key assumptions of Tooley are that being able to desire something is a necessary condition of having a right to it and having a concept of something is a (...) necessary condition of being able to desire it. Despite their plausibility, these premises are at least open to question—that is, these are things that there can presumably be reasonable disagreement about. I …. (shrink)

Purposeful infection of healthy volunteers with a microbial pathogen seems at odds with acceptable ethical standards, but is an important contemporary research avenue used to study infectious diseases and their treatments. Generally termed ‘controlled human infection studies’, this research is particularly useful for fast tracking the development of candidate vaccines and may provide unique insight into disease pathogenesis otherwise unavailable. However, scarce bioethical literature is currently available to assist researchers and research ethics committees in negotiating the distinct issues raised by (...) research involving purposefully infecting healthy volunteers. In this article, we present two separate challenge studies and highlight the ethical issues of human challenge studies as seen through a well-constructed framework. Beyond the same stringent ethical standards seen in other areas of medical research, we conclude that human challenge studies should also include: independent expert reviews, including systematic reviews; a publicly available rationale for the research; implementation of measures to protect the public from spread of infection beyond the research setting; and a new system for compensation for harm. We hope these additions may encourage safer and more ethical research practice and help to safeguard public confidence in this vital research alternative in years to come. (shrink)

ABSTRACT 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. (shrink)

Strategies to increase influenza vaccination rates have typically targeted healthcare professionals and individuals in various high-risk groups such as the elderly. We argue that they should focus on increasing vaccination rates in children. Because children suffer higher influenza incidence rates than any other demographic group, and are major drivers of seasonal influenza epidemics, we argue that influenza vaccination strategies that serve to increase uptake rates in children are likely to be more effective in reducing influenza-related morbidity and mortality than those (...) targeting HCPs or the elderly. This is true even though influenza-related morbidity and mortality amongst children are low, except in the very young. Further, we argue that there are no decisive reasons to suppose that children-focused strategies are less ethically acceptable than elderly or HCP-focused strategies. (shrink)

Many are worried that the Human Genome Project will lead to a revival of eugenics. In this essay I examine the troublesome history of the ‘old eugenics’ which included the Nazi program of ‘Racial Hygiene’ and the sterilization of the ‘feebleminded’ in the United States of America. A ‘new eugenics’, involving prenatal diagnosis and the selective abortion of fetuses likely to develop into severely disabled infants, on the other hand, is claimed by many to be morally acceptable. If this is (...) correct, then eugenics per se might not necessarily be an altogether bad thing. I therefore examine what was wrong with the old eugenics and what is often claimed to be different and better about the new eugenics. I argue that the morally relevant differences between the bad old eugenics and a potentially acceptable new eugenics are not accurately captured by a family of contrasts often thought to distinguish the two. I conclude that, in any case, the worry that the Human Genome Project will lead to a revival of eugenics is a red herring. The important thing is to realize that emerging genetic science and technology confronts both individuals and society as a whole with new kinds of reproductive decisions worthy of careful consideration. (shrink)

Central to the argument of ‘Biodefense and the Production of Knowledge: Rethinking the Problem’ are claims that the vast majority of ethical debate about biodefense research to date has focused on the dual use problem, and the focus of ethical discussion of dual-use research has been on the need to strike ‘a proper balance of only two dominant values: biosecurity and “open science”’ —the idea being that ‘under current conditions other values can and ought to be ignored because the stakes (...) are so high’.1With regard to , Buchanan and Kelley's main point is that policy making regarding biodefense and dual use should be seen as an ‘optimisation problem’—the aim should be to achieve the greater good of society, where all relevant values are taken into account, rather than limiting attention to just two values—security and open science—in particular. While, as other commentators have argued, it is questionable whether these authors have provided an accurate account of ethical discussion of biodefense and dual use to date, in this brief commentary my purpose is to argue that the values of security and open science should themselves be seen as proxies for other values and that solution to …. (shrink)

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, 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. (shrink)

Whether or not MSF should provide unconditional treatment for lead poisoning in Nigeria partly depends on answers to empirical questions regarding what the overall consequences of such a practice are likely to be. Conditional provision of treatment may yield greater health benefits (especially if treatment resources are limited).

Emergencies are extreme events which threaten to cause massive disruption to society and negatively affect the physical and psychological well-being of its members. They raise important practical and theoretical questions about how we should treat each other in times of 'crisis'. The articles selected for this volume focus on the nature and significance of emergencies, demonstrate the normative implications of emergencies and provide multi-disciplinary perspectives on the ethics of emergency response.