Michael J. Selgelid

This open access book provides an extensive review of ethical and regulatory issues related to human infection challenge studies, with a particular focus on the expansion of this type of research into endemic settings and/or low- and middle-income countries (LMICs). Human challenge studies (HCS) involve the intentional infection of research participants, and this type of research is rapidly increasing in frequency worldwide. HCS are widely considered to be an especially promising approach to vaccine development, including for pathogens endemic to LMICs. However, challenge studies are sometimes controversial and raise complex ethical issues, some of which are especially salient in endemic and/or LMIC settings. Informed by qualitative interviews with experts in infectious diseases and bioethics, this book highlights areas of ethical consensus and controversy concerning this kind of research. As the first volume to focus on ethical issues associated with human challenge studies, it sets the agenda for further work in this important area of global health research; contributes to current debates in research ethics; and aims to inform regulatory policy and research practice. Insofar as it focuses on HCS in (endemic) settings where diseases are present and/or widespread, much of the analysis provided here is directly relevant to HCS involving pandemic diseases including COVID19.

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.

The increasing emergence, re-emergence, and spread of deadly infectious diseases which pose health, economic, security and ethical challenges for states and people around the world, has given rise to an important global debate. The actual or potential burden of infectious diseases is sometimes so great that governments treat them as threats to national security. However, such treatment potentially increases the risk that emergency disease-control measures will be ineffective, counterproductive and/or unjust. Research on ethical issues associated with infectious disease is a relatively new and rapidly growing area of academic inquiry, as is research on infectious diseases within the field of security studies. This volume incorporates ethical and security perspectives, thus furthering research in both fields. Its unique focus on the intersection of ethical and security dimensions will, furthermore, generate fresh insights on how governments should respond to infectious disease challenges. Readers should include professionals and scholars working in infectious disease, epidemiology, public health, health law, health economics, public policy, bioethics, medical humanities, health and human rights, social/political philosophy, security studies, and international politics.

What Is the Dual-Use Dilemma? The so-called “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 sci- tific research sometimes has the potential to be used for harm as well as for good. A dual-use dilemma is an ethical dilemma, and an ethical dilemma for the researcher (and for those who have the power or authority to assist or impede the researcher’s work, e. g. , governments). It is an ethical dilemma since it is about promoting good in the context of the potential for also causing harm, e. g. , the p- motion of health in the context of providing the wherewithal for the killing of in- cents. It is an ethical dilemma for the researcher not because he or she is aiming at anything other than a good outcome; typically, the researcher intends no harm, but only good. Rather, the dilemma arises for the researcher because of the potential actions of others. Malevolent non-researchers might steal dangerous biological agents produced by the researcher; alternatively, other researchers—or at least their governments or leadership—might use the results of the original researcher’s work for malevolent purposes. The malevolent purposes in question include bioterrorism, biowarfare and blackmail for financial gain.