61. Global health emergencies are not amenable to easy definition. The agencies, communities, and people who are brought together in the conduct of research within such emergencies bring with them different moral concerns, commitments, and values.
Engaging seriously with these differences is an important requirement for any attempt to understand the ethical dimensions of research in emergencies.
62. Resisting moral relativism or bioethical paralysis in the face of these problems, our response has been to attempt to offer sensible advice to those who face them in practice.
Our contribution has two elements. One of these is crystallised in our concept of an ethical compass, comprising substantive normative commitments to equal moral respect, helping reduce suffering, and fairness. Our second contribution, illustrated by our choice of focus for Chapters 5–10, has been to identify a number of particularly salient, morally significant, aspects of research in global health emergencies, and to offer an informed, in-depth analysis of the nature of the problems and difficult decisions to be made, in the light of the evidence we received.
63. Important cross-cutting themes of this report include:
■ How the successful conduct of research to high ethical standards depends crucially upon the moral and ethical work undertaken every day by front-line research workers, health professionals, and volunteers. The importance of this work – the moral craft of day-to-day ethical research – is very often not fully appreciated or rewarded. It is, however, essential.
■ The vital importance of properly resourced preparedness between emergencies.
Preparedness and emergency planning are essential for many reasons: they mean emergencies are less likely to happen and more manageable when they do occur.
They also mean that the requirements for valuable, ethical research to be conducted are more likely to be in place.
64. Above all, we have tried to bear in mind throughout our deliberations that research undertaken in the context of global health emergencies involves real people, families, and communities. It asks a great deal of them, primarily in the interests of others, at a time of great distress, fear, and vulnerability. We take this opportunity to acknowledge and celebrate the contribution of those who take part in such research.
INTRODUCTION
Introduction
This report from an international working group established by the Nuffield Council on Bioethics explores the complex and contested question of how research can be conducted ethically during major health emergencies and humanitarian crises. The importance of this issue for the many millions of people threatened by, or living with the consequences of, health emergencies around the world is increasingly recognised. In June 2017, for example, The Lancet published a special series highlighting the essential role research can play in improving the effectiveness of the health response to those affected by humanitarian crises – and mapping the limited quantity and quality of such research data in many aspects of health-related humanitarian activity.1 In setting out its agenda for improving the evidence for health in humanitarian crises, the series brought to the fore the tension between the claim that there is an ethical imperative to gather good data in order to provide better services, and the belief reportedly still held by many practitioners that research in disaster settings is unethical.2 Recent outbreaks of Ebola have similarly drawn international attention both to the valuable role of health research in such contexts (for example in improving the evidence base for the effectiveness of experimental vaccines); and to the concerning lack of consensus about how such research might be conducted ethically.
In this report, we explore these ethical questions with reference to many kinds of health-related emergency around the world. These range from outbreaks of infectious diseases for which there are currently no effective licensed treatments – such as the Ebola, Zika, and Nipah viruses – to the health impacts of both natural and human-made disasters, including the consequences of conflict and mass movements of people, and complex emergencies where two or more of these forms of disaster come together.3 The World Health Organization (WHO) has highlighted a number of causes underlying the increasing number of infectious disease outbreaks, commenting that: “climate change, emerging diseases, exploitation of the rainforest, large and highly mobile populations, weak governments and conflict [are] making outbreaks more likely to occur and more likely to swell in size once they did”.4 Conflict and extreme climate events underpin the increasing number of people in need of humanitarian assistance;5 and both the numbers of displaced people, and the length of time they are displaced, are increasing.6
The aims of the Nuffield Council’s project are twofold: on the one hand, to support and promote the contribution that ethically-conducted research can make to current and future emergency preparedness and response; and on the other to help reduce the risk that unethical health-related research is conducted during emergencies. In support of these aims, the working group
1 The Lancet (2017) Health in humanitarian crises (series), available at:
https://www.thelancet.com/series/health-in-humanitarian-crises. See also: Kohrt BA, Mistry AS, Anand N et al. (2019) Health research in humanitarian crises: an urgent global imperative BMJ Global Health 4(6): e001870.
2 O’Mathúna D, and Siriwardhana C (2017) Research ethics and evidence for humanitarian health The Lancet 390(10109):
2228-9.
3 For example, the Fukushima earthquake / tsunami / nuclear disaster.
4 BBC News (7 June 2019) Large Ebola outbreaks new normal, says WHO, available at: https://www.bbc.co.uk/news/health-48547983. See also: Fouque F, and Reeder JC (2019) Impact of past and on-going changes on climate and weather on vector-borne diseases transmission: a look at the evidence Infectious Diseases of Poverty 8(1): 51; Global Preparedness Monitoring Board (2019) A world at risk: annual report on global preparedness for health emergencies, available at:
https://apps.who.int/gpmb/assets/annual_report/GPMB_annualreport_2019.pdf; and SciDev.net (24 June 2019)
Humanitarians turn sights on climate risk, available at: https://www.scidev.net/global/climate-change/feature/humanitarians-turn-sights-on-climate-risk.html.
5 OCHA (2019) Global humanitarian overview 2020, available at: https://www.unocha.org/sites/unocha/files/GHO-2020_v8.7%2006122019%202pm.pdf, at page 4.
6 ibid., at page 13; and International Displacement Monitoring Centre (2019) Global report on internal displacement, available at: http://www.internal-displacement.org/global-report/grid2019/.
has sought to provide an in-depth characterisation of where the ethical problems lie; help develop a common understanding of what constitutes ethical research and research ethics in such circumstances; and, where appropriate, make practical recommendations for change.
In approaching this challenging topic, we recognise the substantial body of academic and policy work already undertaken in this field. These include (to name only a few) the ethical consensus statement generated in response to research experiences in the aftermath of the 2004 tsunami;7 guidance developed by the World Health Organization (WHO) in response to the challenges of the 2014–16 Ebola outbreak;8 literature on areas such as the ethical challenges of the humanitarian health sector9 and the ethics of study design in infectious disease outbreaks;10 and the ongoing work of the Post-Research Ethics Analysis (PREA) project to develop a tool to assist researchers in reflecting on ethical issues in humanitarian research.11 Our aim has been to build on, and complement, existing and contemporaneous work. Here, we bring together in one place the relevant ethical issues, and considerations for how to approach them, while recognising that this is an area in which consensus on the right approach may be hard-won.
A note on methodology. Throughout this project, we have sought input from as diverse a range of contributors as possible: in terms of geography, and in type of emergency, research topic, discipline, and professional role; from the highly personal experiences of participants and researchers to the policies and concerns of major institutions. We have also heard from those whose primary concern is to respond directly to the health needs of those affected by emergencies, and for whom research is rightly a secondary concern. We have hosted or attended workshops in the Philippines, Singapore, Lebanon, and Senegal; and attended international conferences in China, South Africa, the US, Ireland, and the UK (see Appendix 1). Our working group includes members from Hong Kong, Ghana, Liberia, and Brazil, and UK-based colleagues from India and Uganda; and we received responses to our call for evidence from over 30 countries (see Appendices 1 and 2, and map overleaf). We have endeavoured throughout to base our thinking and our findings on what we have heard from these very rich sources, alongside what is reported through the published literature. We are nevertheless aware that our gaze has been restricted, not least by our focus on literature and communication in English. Recognising these limitations, we hope that this report will provide a fruitful starting point for further debate, both in an inclusive manner at international level, and at country level as national institutions grapple with their own emergency planning.
7 Sumathipala A, Jafarey A, Castro L et al. (2010) Ethical issues in post-disaster clinical interventions and research: a developing world perspective. Key findings from a drafting and consensus generation meeting of the Working Group on Disaster Research and Ethics (WGDRE) 2007 Asian Bioethics Review 2(2): 124-42.
8 WHO (2016) Guidance for managing ethical issues in infectious disease outbreaks, available at:
http://apps.who.int/iris/bitstream/10665/250580/1/9789241549837-eng.pdf.
9 See, for example, Hunt M, Schwartz L, Pringle J et al. (2014) A research agenda for humanitarian health ethics PLoS Currents 6: ecurrents.dis.8b3c24217d80f3975618fc9d9228a144; Eckenwiler L, Pringle J, Boulanger R et al. (2015) Real-time responsiveness for ethics oversight during disaster research Bioethics 29(9): 653-61; and Gailits N, Nouvet E, Pringle J et al. (2019) Blurring lines: complexities of ethical challenges in the conduct of West African Ebola research, available at:
https://www.elrha.org/wp-content/uploads/2019/10/Gailits-et-al.-Blurring-Lines-Ethical-Challenges-in-West-African-Ebola-Research.pdf.
10 See, for example, Rid A, and Emanuel EJ (2014) Ethical considerations of experimental interventions in the Ebola outbreak The Lancet 384(9957): 1896-9; and Lanini S, Zumla A, Ioannidis JPA et al. (2015) Are adaptive randomised trials or non-randomised studies the best way to address the Ebola outbreak in West Africa? The Lancet Infectious Diseases 15(6): 738-45.
11 PREA (2019) Getting started with the PREA Tool, available at: https://www.preatool.com/guide/domain/.
INTRODUCTION
Taking a broad approach to the ethics of research
This report makes the case for considerably broadening the traditional understanding of what is thought of as ‘research ethics’. A rigorous approach to the standard research ethics questions of appropriate study design, independent scrutiny, and the fair treatment of research participants is essential for the ethical conduct of research, but is not sufficient. Research ethics questions cannot be considered in a vacuum without reference to context: both the specifics of an emergency as it unfolds at a particular time and location; and with respect to broader structural, political, and power concerns. Health-related research in many health emergencies takes place in the context of deep historical inequities and ongoing imbalances in power and influence, raising important questions of justice.12
We recognise that there are many factors that this report cannot influence, not least the causes of conflict that underlie or exacerbate many humanitarian crises. Nevertheless we have kept these larger concerns in view and acknowledge their importance when we consider the duties and responsibilities of the many stakeholders concerned in regulating, funding, facilitating, reviewing, conducting, and reporting research concerned with the health response to an emergency. Existing levels of inequity, both between and within countries, whether in terms of the capacity of their health and research infrastructures, in their economic circumstances, or in their global influence, have important consequences for those duties and responsibilities.
For example: how are decisions made as to what research to fund and, by necessary implication, what not to fund? In what direction does the value of the research flow? Whose voices are being heard at different points in the research endeavour and whose benefit is being considered and prioritised? What is required to promote well-founded trust between participants, researchers, and other key players such as local health professionals in contexts
12 See, for example, Keller RC (2006) Geographies of power, legacies of mistrust: colonial mistrust in the global present Historical Geography 34: 26-48; and Nunes J (2016) Ebola and the production of neglect in global health Third World Quarterly 37(3): 542-56.
where the grounds for such trust may be absent in the early stages of emergency response?
In brief, ethics is not just about the behaviour of people on the ground, but also the functioning of processes that, however remote they may seem at times to front-line research workers and participants, exert powerful influence on the options actually open to those directly involved in research activities.
During the writing of this report, it became clear that for a significant number of actors in the research community, and among emergency responders, the word ‘ethics’ has acquired a bad name, being primarily associated with bureaucratic and burdensome processes, rather than being concerned with questions relating to good conduct throughout the whole research endeavour.13 Such a (mis)perception needs to be taken seriously. The need for more flexible and responsive approaches to ethical scrutiny must be recognised: processes should never become ends in themselves, and must add value if they are to be justified. At the same time, it was equally clear to us that many researchers working in this area consider, and are deeply sensitive to, questions of right conduct in research and the fair treatment of participants and collaborators, whether or not they badge these considerations as ‘ethical’. For example, imbalances of influence and power in research, and the way these contribute to inequitable collaborations, and to the prioritising of the research needs of some populations over others, emerged as matters of serious concern to many researchers. By focusing on the significance of these higher-level ethical questions, and their relevance for policies that shape researchers’
work, we hope to show how ‘ethics’ can and do support people in real-world settings struggling with complex realities on the ground. Similarly, throughout this report we aim to translate ethical considerations and approaches into practical policy recommendations that could change future practice.
Structure of this report
Chapters 1–3 set out the background that provides the empirical basis for the rest of the report:
■ Chapter 1 sets out the scope of our inquiry, explaining the broad approach taken to what constitutes a ‘global health emergency’ and the nature of the research and other evidence-gathering activities with which we are concerned. It also sketches out the complicated regulatory background against which research takes place.
■ Chapter 2 draws on the contributions we received directly, and on the published literature, to present the experiences of those affected by various kinds of emergency both in leading / participating in emergency response, and in participating in associated research. It then presents the experiences of researchers on the ground.
■ Chapter 3 provides an overview of some of the many organisational and structural factors that control and influence how research may be conducted in an emergency, with a particular focus on the role of nation states, intergovernmental organisations, and multi-country / multi-agency collaborations in emergency preparedness.
Chapter 4 explores the ethical questions emerging from the evidence presented in these first three chapters and sets out an ‘ethical compass’ to guide both policy and practice.
Chapters 5–10 consider the implications of this ethical compass across different areas:
■ Chapter 5 explores questions of power and influence throughout the research endeavour, with a focus on how the voice of affected populations and other
13 See, for example, Parker M, and Allen T (2013) Questioning ethics in global health, in Ethics in the field: contemporary challenges, MacClancy J, and Fuentes A (Editors) (Oxford: Berghahn), who further express concerns as to how at times ethics processes may be used to protect vested interests.
INTRODUCTION stakeholders can be meaningfully included in determining what research takes place,
where, and how.
■ Chapter 6 looks at questions of study design and review, with links to the earlier discussion of stakeholder engagement.
■ Chapter 7 explores issues of ‘consent and beyond’, considering the role of the wider ethics ecosystem alongside participant consent in ensuring the fair treatment of research participants.
■ Chapter 8 is concerned with ethical and effective collaborations both within the research sector, and between response and research actors.
■ Chapter 9 considers the issues that arise in sharing data and samples.
■ Chapter 10 explores the role of front-line research workers, and what might be required to ensure that they are better supported.
Chapter 11 is the final chapter, and draws together common themes across the report, with emphasis on the moral and ethical work undertaken every day by front-line research workers, health professionals, and volunteers; and on the vital importance of properly resourced emergency preparedness.
Chapter 1
Scope and context
Chapter 1 – Scope and context
Chapter 1: overview
This report takes a broad and inclusive approach, both to circumstances that might be characterised as ‘global health emergencies’, and to what activities constitute health-related research.
Our concern with ‘research’ encompasses a broad range of evidence-generating activities whose primary aim is to improve the health-related aspects of emergency preparedness, mitigation, and response. These include clinical trials of novel treatments and vaccines, social science research, epidemiological studies, implementation
research, and health systems research, as well as less formalised ways in which data are used to improve response within the humanitarian sector. ‘Global health
emergencies’ should not be rigidly defined but include situations with many or all of the following features that render much-needed research very difficult:
■ Disruption from some kind of relatively stable norm (including where such disruption is long-term, for example where populations are left without civil or political rights). Potential causes of such disruption include infectious disease outbreaks, natural disasters, and human-made disasters such as conflict, bioterrorism, and industrial accidents.
■ Significantly raised risks to physical or mental well-being at both individual and population level;
■ Pressures of time, creating tensions between research and response timescales, and exacerbating the challenges of multidisciplinary working;
■ Uncertainty, making decision-making in these time-limited contexts particularly difficult for all concerned;
■ Fear, distress, and sometimes panic, potentially undermining populations’ ability or desire to engage with research; and
■ Need for a multi-country and multi-agency response associated with inevitable tensions and differences in approach between different actors, and with scope for disagreement over control, responsibility, and legitimacy.
It is these challenges, rather than the health implications of the emergency for other countries, that provide the primary justification for our focus on ‘global’ health emergencies.
Those undertaking research in the challenging circumstances of a global health emergency are accountable to a patchwork of sometimes inconsistent and conflicting regulatory and governance mechanisms. In addition to the requirements of national legal systems, these include international human rights and humanitarian law; ethical
guidelines for different kinds of research operating at international, regional, and local level; and specific technical requirements for investigational medicinal products.
Introduction
1.1 We begin by briefly outlining the scope of this report: both in terms of the kind of health
1.1 We begin by briefly outlining the scope of this report: both in terms of the kind of health