Michael Selgelid

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.

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.

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.

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.

Claims about the transformations enabled by modern science and medicine have been accompanied by an unsettling question in recent years: might the knowledge being produced undermine--rather than further--human and animal well being? On the Dual Uses of Science and Ethics examines the potential for the skills, know-how, information, and techniques associated with modern biology to serve contrasting ends. In recognition of the moral ambiguity of science and technology, each chapter considers steps that might be undertaken to prevent the deliberate spread of disease. Central to achieving this aim is the consideration of what role ethics might serve. To date, the ethical analysis of the themes of this volume has been limited. This book remedies this situation by bringing together contributors from a broad range of backgrounds to address a highly important ethical issue confronting humanity during the 21st century.

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.

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 …

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.

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 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.

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.

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.

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, …

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.

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 …

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.