Michael Selgelid

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.

This paper considers multiple meanings of the expression ‘dual use’ and examines lessons to be learned from the life sciences when considering ethical and policy issues associated with the dual-use nature of nanotechnology (and converging technologies). After examining recent controversial dual-use experiments in the life sciences, it considers the potential roles and limitations of science codes of conduct for addressing concerns associated with dual-use science and technology. It concludes that, rather than being essentially associated with voluntary self-governance of the scientific community, codes of conduct should arguably be part of a broader regulatory oversight system.

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?

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.

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

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

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; ethical issues in emergency public policy and law; war, terrorism and supreme emergencies; and public health and humanitarian emergencies. Together they demonstrate the normative implications of emergencies and provide multi-disciplinary perspectives on the ethics of emergency response.

Janet Radcliffe Richards’ The Ethics of Transplants outlines a novel framework for moral inquiry in practical contexts and applies it to the topic of paid living kidney donation. In doing so, Radcliffe Richards makes two key claims: that opponents of organ markets bear the burden of proof, and that this burden has not yet been satisfied. This paper raises four related objections to Radcliffe Richards’ methodological framework, focusing largely on how Radcliffe Richards uses this framework in her discussion of kidney sales. We conclude that Radcliffe Richards’ method of inquiry hinders our ability to answer the very question that it ought to help us resolve: What is there best reason to do, all things considered?

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

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.

Antimicrobial resistance (AMR) is a global public health disaster driven largely by antibiotic use in human health care. Doctors considering whether to prescribe antibiotics face an ethical conflict between upholding individual patient health and advancing public health aims. Existing literature mainly examines whether patients awaiting consultations desire or expect to receive antibiotic prescriptions, but does not report views of the wider public regarding conditions under which doctors should prescribe antibiotics. It also does not explore the ethical significance of public views or their sensitivity to awareness of AMR risks or the standpoint (self-interested or impartial) taken by participants. Methods: An online survey was conducted with a sample of the U.S. public (n = 158). Participants were asked to indicate what relative priority should be given to individual patients and society-at-large from various standpoints and in various contexts, including antibiotic prescription. Results: Of the participants, 50.3% thought that doctors should generally prioritize individual patients over society, whereas 32.0% prioritized society over individual patients. When asked in the context of AMR, 39.2% prioritized individuals whereas 45.5% prioritized society. Participants were significantly less willing to prioritize society over individuals when they themselves were the patient, both in general (p = .001) and in relation to AMR specifically (p = .006). Conclusions: Participants’ attitudes were more oriented to society and sensitive to collective responsibility when informed about the social costs of antibiotic use and when considered from a third-person rather than first-person perspective. That is, as participants came closer to taking the perspective of an informed and impartial “ideal observer,” their support for prioritizing society increased. Our findings suggest that, insofar as antibiotic policies and practices should be informed by attitudes that are impartial and well-informed, there is significant support for prioritizing society.

The 2016 outbreak of the Zika arbovirus was associated with large numbers of cases of the newly-recognised Congenital Zika Syndrome. This novel teratogenic epidemic raises significant ethical and practical issues. Many of these arise from strategies used to avoid cases of CZS, with contraception in particular being one proposed strategy that is atypical in epidemic control. Using contraception to reduce the burden of CZS has an ethical complication: interventions that impact the timing of conception alter which people will exist in the future. This so-called ‘non-identity problem’ potentially has significant social justice implications for evaluating contraception, that may affect our prioritisation of interventions to tackle Zika. This paper combines ethical analysis of the non-identity problem with empirical data from a novel survey about the general public's moral intuitions. The ethical analysis examines different perspectives on the non-identity problem, and their implications for using contraception in response to Zika. The empirical section reports the results of an online survey of 93 members of the US general public exploring their intuitions about the non-identity problem in the context of the Zika epidemic. Respondents indicated a general preference for a person-affecting intervention over an impersonal intervention. However, their responses did not appear to be strongly influenced by the non-identity problem. Despite its potential philosophical significance, we conclude from both theoretical considerations and analysis of the attitudes of the community that the non-identity problem should not affect how we prioritise contraception relative to other interventions to avoid CZS.

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.

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