Research Ethics in Epidemics and Pandemics: A Casebook

Susan Bull BSc, LLB, MA, PhD is an Associate Professor in Bioethics at the Ethox Centre, University of Oxford, United Kingdom and an Associate Professor of Medical Ethics, Faculty of Medical and Health Sciences, University of Auckland New Zealand. Her research interests centre on ethical dimensions of health and global health with a thematic focus on the exercise of epistemic power. Her conceptual and empirical research has addressed global health data sharing, consent to research, ethical review of research, controlled human infection (challenge) studies, and infectious disease outbreaks, epidemics and pandemics. Susan leads Epidemic Ethics, a global community of bioethicists and stakeholders involved in public health and research responses to public health emergencies. Susan has served in multiple advisory roles including as a member of the WHO Working Group for Guidance on Human Challenge Studies in COVID-19 and lead writer of WHO Guidance on the Ethical Conduct of Controlled HumanInfection Studies. Susan has chaired and served on research ethics committees in the UK and New Zealand, and provided training to research ethics committees in Europe, Asia, Africa and New Zealand. In collaboration with colleagues at the University of Oxford, The Global Health Network, World Health Organization, Nuffield Council on Bioethics, and Multi-Regional Clinical Trials Center at Brigham and Women’s Hospital and Harvard, Susan developed a suite of free online research ethics training courses taken by over 450,000 learners.Michael Parker is Professor of Bioethics and Director of the Ethox Centre at the University of Oxford. Ethox is a multidisciplinary bioethics research centre with a major programme of research on global health bioethics. In 2012, together with colleagues in Kenya, Malawi, South Africa, Thailand and Vietnam, Michael established the Global Health Bioethics Network (GHBN). Since that time, GHBN has expanded to include colleagues in a numberof other countries including: Brazil, Cambodia, Ghana, Laos, Malaysia, Myanmar, and Nepal. Michael has a strong research interest in infectious diseases ethics. In 2019, together with Jeff Kahn at the Berman Institute of Bioethics, he established the Oxford-Johns Hopkins Global Infectious Diseases Collaborative (GLIDE) which conducts collaborative research on infectious disease ethics together with partners in a range of low and middle-income countries. In addition to, and complementary to, these research interests Michael has also been involved a range of policy related activities in the arena of global health. From 2018 until 2020 he chaired a Nuffield Council of Bioethics international working group on the ethics of research in global health emergencies. From 2020 – 2022, he was a participant in the UK Government’s Scientific Advisory Group for Emergencies (SAGE) which advised on COVID-19. And since, 2020, he has been a member of the WHO COVID-19 Ethics & Governance Working Group.Joseph Ali, JD is Associate Professor of International Health at the Johns Hopkins Bloomberg School of Public Health and Core Faculty/Associate Director for Global Programs at the Johns Hopkins Berman Institute of Bioethics. His research engages a range of challenges in global health ethics, and includes empirical and normative work to address the implications of emerging global mobile and digital technologies as applied in the context of health research, public health programs, and disease surveillance. At Johns Hopkins, he serves as a member of the Bloomberg School of Public Health (JHSPH) Institutional Review Board (IRB) and has been involved in establishing and operating U.S National Institutes of Health (NIH) funded non-degree, master’s, doctoral and post-doctoral training programs in bioethics at Johns Hopkins and with partners in Uganda, Ethiopia, Zambia, Botswana and Malaysia. He is Associate Editor for the Journal of Empirical Research on Human Research Ethics and teaches courses in international research ethics, public health ethics and digital health ethics at Johns Hopkins.Monique Jonas is an ethical theorist based at the School of Population Health at the University of Auckland, New Zealand, where she teaches ethics to medical and health sciences students. She has a Doctorate in Medical Ethics from Kings College London. Her programme of research spans a wide range of ethical and political-philosophical concerns connected with health, including the ethics of advising; ethical aspects of parenting and decision making for children and young people; the relationship between the family and the state; research involving secondary data, and population health. Monique is the Chair of the Health Research Council Ethics Committee and has served on the National Ethics Advisory Committee and the National Health Committee in New Zealand. Carla Saenz is the Regional Bioethics Advisor at the Pan American Health Organization (PAHO), which serves as the World’s Health Organization's Regional Office for the Americas. She is responsible for PAHO’s Regional Program on Bioethics, which provides support on bioethics to countries in Latin America and the Caribbean, e.g. strengthening national research ethics systems, integrating ethics in health-related work, and building capacity in bioethics. Dr. Saenz also manages PAHO’s ethics review committee, which reviews research conducted with PAHO’s involvement in the region. An elected fellow of the Hastings Center, she has authored numerous publications on different areas of bioethics, coedited the book Public Health Ethics: Cases Spanning the Globe, and contributed to several ethics guidance documents. She has been responsible for the development of PAHO’s zika ethics guidance, and numerous ethics guidance documents issued by PAHO during the COVID-19 pandemic including Catalyzing Ethical Research in Emergencies. Ethics Guidance, Lessons Learned from the COVID-19 Pandemic, andPending Agenda. Dr. Saenz serves on the board of the International Association of Bioethics and the Steering Committee of the Global Forum on Bioethics in Research. She holds a PhD in Philosophy from the University of Texas at Austin and, before joining PAHO, she was at the Department of Bioethics at Clinical Center of the National Institutes of Health (NIH), and in the faculty in the Philosophy Department at the University of North Carolina at Chapel Hill.Maxwell J. Smith, PhD, is an Assistant Professor and Western Research Chair in Public Health Ethics in the Faculty of Health Sciences at Western University in London, Ontario, Canada. He also serves as an Associate Director of Western's Rotman Institute of Philosophy and has cross-appointments in Western's Department of Philosophy, Department of Epidemiology and Biostatistics, and Schulich Interfaculty Program in Public Health. His research is in the area of public health ethics, with a focus on infectious disease ethics and the demands that health equity and social justice place on governments and institutions to protect and promote the public’s health. Professor Smith has served in a number of advisory roles to governments and health authorities, including as a member of Ontario’s COVID-19 Vaccine Distribution Task Force, the Public Health Agency of Canada’s Public Health Ethics Consultative Group, and World Health Organization's COVID-19 Ethics and Governance Expert Working Group, and serves as a consultant to Epidemic Ethics.Jantina de Vries is the director of The Ethics Lab at the Neuroscience Institute and an Associate Professor in Bioethics in the Department of Medicine of the University of Cape Town. The Ethics Lab brings together a multidisciplinary group of scholars that foster transformative ethics scholarship that centres Africa as the context and driver for global health ethics. She leads two core grants that support that work: a Wellcome Trust Research Development Programme that seeks to articulate how knowledge from the African humanities could and should inform on the ethics of new and emerging health technologies; and an award from the Fogarty International Centre (NIH) award that aims to develop an MSc degree that teaches ethics from the South. With colleagues at the University of Ghana and elsewhere, she is also contributing to the development of a solidarity index for global health funders. Jantina’s primary expertise is in the ethics of African genomics research. She was a member of the WHO Genome Editing Expert Advisory Committee and is currently a member of the Research Ethics Board of Médecins Sans Frontières and the Steering Committee of the Global Forum for Bioethics in Research. Jantina obtained her DPhil through The Ethox Centre at the University of Oxford (2011), and undergraduate and postgraduate degrees in sociology at Wageningen University (2003). She has published over 120 articles in international peer reviewed journals. Her work is funded by the Wellcome Trust, the European Commission, the National Institutes of Health and the National Research Foundation of South Africa.Teck Chuan Voo, trained in Philosophy and Medical Jurisprudence, Dr. Teck Chuan Voo is Assistant Professor at the Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore. He researches on healthcare ethics and the ethics of infectious disease control and prevention, with focus on emergency situations. He is on the editorial board of the journals, the Asian Bioethics Review and Public Health Ethics; and the Springer Nature book series on Philosophy and Medicine, Public Health and Health Policy Ethics and its companion series, the Springer Briefs in Public Health and Health Policy Ethics. Teck Chuan is an appointed member of various ethics committees in Singapore, including the Bioethics Advisory Committee and the National Medical Ethics Committee. He is on the Steering Committee of theGlobal Forum on Bioethics in Research and the ethics advisory board for UNITE4TB. He has served the WHO in various capacities in the development of clinical guidelines, and ethics guidance relating to epidemics and public health emergencies. He sits on the Board of Directors for the International Association of Bioethics.Katharine Wright is a freelance ethics consultant, working with a number of international organisations including the WHO Health Ethics and Governance Unit, the MRCT Center of Brigham and Women's Hospital and Harvard, and the Council of Europe. She is also a member of the BMJ Ethics Committee. Her background is in the intersection of bioethics with policy and practice, with a particular interest in issues of power, vulnerability and inclusion in health policy and research. From 2007-2022 she was Assistant Director at the UK-based Nuffield Council on Bioethics, directing projects on the ethical aspects of a wide range of policy issues, including ageing and dementia, the inclusion of children in research, the conduct of research in global health emergencies, the donation of bodily materials, and the promotion of cosmetic procedures. Before joining the Nuffield Council, she spent 9 years at the UK House of Commons, briefing MPs of all political parties on health issues, and then four years in the NHS, monitoring the effect of the Human Rights Act on health law in England. During her time at the House of Commons, she was also seconded to the English Department of Health to work on patient consent.

• Chapter 1: Introduction: Research Ethics and Health Policy in Epidemics and Pandemics.- Chapter 2: Setting Research Priorities.- Chapter 3: Research Quality and Dissemination.- Chapter 4: Boundaries Between Research, Surveillance and Monitored Emergency Use.- Chapter 5: Adapting and adaptive research. Chapter 6: Ethics Review Challenges.- Chapter 7: Ethical Issues Associated with Managing and Sharing Individual-Level Health Data During a Public Health Emergency.- Chapter 8: Dimensions of Vulnerability.- Chapter 9: Participant Recruitment, Consent and Post-Trial Access to Interventions.- Chapter 10: Afterword.

“The book consists of nine thematic chapters with associated cases as well as a concluding chapter that both summarizes the aspects of research ethics that have been highlighted in the various chapters and looks ahead to future research. ... Research Ethics in Epidemics and Pandemics: A Casebook is extremely rewarding in terms of content regarding the various themes that are problematized, even when the research area is unfamiliar to the reader.” (Marita Cronqvist, Metascience, Vol. 34 (1), 2025)