Michael Selgelid

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

Suppose we accept prenatal diagnosis and the selective abortion of fetuses that test positive for severe genetic disorders to be both morally and socially acceptable. Should we consider prenatal diagnosis and selective abortion (or other genetic interventions such as preimplantation diagnosis, genetic therapy, cloning, etc.) for nontherapeutic purposes to be acceptable as well? On the one hand, the social aims to promote liberty in general, and reproductive liberty in particular, provide reason for thinking that individuals should be free to make their own decisions about whether or not to employ whatever genetic services might be developed and offered by private enterprise. On the other hand, interventions aimed at enhancement would (in many cases) presumably only be available to those who are financially fortunate. A worry is that unequal access to enhancements that provide competitive advantages to offspring will further and more permanently increase existing unjust disparities between the haves and have-nots. The aim to promote liberty might thus conflict with the social aim of equality. An additional worry is that the development and provision of nontherapeutic genetic interventions would drain limited medical resources away from therapeutic purposes which would ultimately be more fruitful. The promotion of liberty might also thus conflict with the aim to promote aggregate utility. Assuming there is no reason to think that the promotion of liberty should be given absolute priority over both equality and aggregate utility, we need to think more about how to make trade-offs between these three legitimate social aims

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.

Human infection challenge studies 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 assessments. Modelling will be particularly useful in comparing potential benefits and risks of HCS with those of vaccine field trials under different epidemiological conditions and 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.

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

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.

BackgroundResuscitation and treatment of critically ill newborn infants is associated with relatively high mortality, morbidity and cost. Guidelines relating to resuscitation have traditionally focused on the best interests of infants. There are, however, limited resources available in the neonatal intensive care unit, meaning that difficult decisions sometimes need to be made. This study explores the intuitions of lay people regarding resource allocation decisions in the NICU.MethodsThe study design was a cross-sectional quantitative survey, consisting of 20 hypothetical rationing scenarios. There were 119 respondents who entered the questionnaire, and 109 who completed it. The respondents were adult US and Indian participants of the online crowdsourcing platform Mechanical Turk. Respondents were asked to decide which of two infants to treat in a situation of scarce resources. Demographic characteristics, personality traits and political views were recorded. Respondents were also asked to respond to a widely cited thought experiment involving rationing.ResultsThe majority of respondents, in all except one scenario, chose the utilitarian option of directing treatment to the infant with the higher chance of survival, higher life expectancy, less severe disability, and less expensive treatment. As discrepancy between outcomes decreased, however, there was a statistically significant increase in egalitarian responses and decrease in utilitarian responses in scenarios involving chance of survival, life expectancy, and cost of treatment. In the classic ‘lifeboat’ scenario, all but two respondents were utilitarian.ConclusionsThis survey suggests that in situations of scarcity and equal clinical need, non-health professionals support rationing of life-saving treatment based on probability of survival, duration of survival, cost of treatment or quality of life. However, where the difference in prognosis or cost is very small, non-health professionals preferred to give infants an equal chance of receiving treatment.

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.

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?

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.

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.

The non-identity problem arises when our actions in the present could change which people will exist in the future, for better or worse. Is it morally better to improve the lives of specific future people, as compared to changing which people exist for the better? Affecting the timing of fetuses being conceived is one case where present actions change the identity of future people. This is relevant to questions of public health policy, as exemplified in some responses to the Zika epidemic. There is philosophical disagreement about the relevance of non-identity: some hold that non-identity is not relevant, while others think that the only morally relevant actions are those that affect specific people. Given this disagreement, we investigated the intuitions about the moral relevance of non-identity within an educated sample of the public, because there was previously little empirical data on the public’s views on the non-identity problem. We performed an online survey with a sample of the educated general public. The survey assessed participants’ preferences between person-affecting and impersonal interventions for Zika, and their views on other non-identity thought experiments, once the non-identity problem had been explained. It aimed to directly measure the importance of non-identity in participants’ moral decision-making. We collected 763 valid responses from the survey. Half of the participants (50%) had a graduate degree, 47% had studied philosophy at a university level, and 20% had read about the non-identity problem before. Most participants favoured person-affecting interventions for Zika over impersonal ones, but the majority claimed that non-identity did not influence their decision (66% of those preferring person-affecting interventions, 95% of those preferring impersonal ones). In one non-identity thought experiment participants were divided, but in another they primarily answered that impersonally reducing the quality of life of future people would be wrong, harmful and blameworthy, even though no specific individuals would be worse off. Non-identity appeared to play a minor role in participants’ moral decision-making. Moreover, participants seem to either misunderstand the non-identity problem, or hold non-counterfactual views of harm that do not define harm as making someone worse off than they would have been otherwise.

Interactions between microbes and human hosts can lead to a wide variety of possible outcomes including benefits to the host, asymptomatic infection, disease (which can be more or less severe), and/or death. Whether or not they themselves eventually develop disease, asymptomatic carriers can often transmit disease-causing pathogens to others. This phenomenon has a range of ethical implications for clinical medicine, public health, and infectious disease research. The implications of asymptomatic infection are especially significant in situations where, and/or to the extent that, the microbe in question is transmissible, potentially harmful, and/or untreatable. This article reviews the history and concept of asymptomatic infection, and relevant ethical issues associated with this phenomenon. It illustrates the role and ethical significance of asymptomatic infection in outbreaks, epidemics, and pandemics–including recent crises involving drug resistance, Zika, and Covid19. Serving as the Introduction to this Special Issue of Monash Bioethics Review, it also provides brief summaries of the other articles comprising this collection.

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 …