Last December, the Nuffield Council on Bioethics hosted a workshop, bringing together experts from a wide range of disciplines to explore the ethical challenges of conducting research in global health emergencies. One of the key issues that emerged from that debate (pdf) was the way in which, in the context of a humanitarian emergency, the traditional divide between ‘research’ and ‘practice’ becomes harder and harder to maintain – and indeed may become a barrier to an ethical response.
From the perspectives both of those affected by the emergency, and also of frontline workers, ‘research’ activities cannot simply be isolated from other activities that form part of emergency response, including humanitarian initiatives, care services, and public health measures. When there is no evidence-based treatment to offer in response to disease associated with high mortality, for example, but sufficient evidence to justify offering experimental interventions in the context of research, such an offer will in practice be understood as experimental treatment – not only by participants/patients but also by those who are providing it.
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In such cases, people do not agree to take part in the research in order to help generate generalizable knowledge for future good – they agree (and for very good reason) to take part in the research in the hope of personal clinical gain. At the same time, there is surely an ethical imperative to seek to learn as much as possible, as systematically as possible, about the effects of such unproven interventions, both in order to provide the best possible care for those receiving them now, and for future benefit.
Speakers at the Oxford Global Health Bioethics conference in July 2017 highlighted these difficulties vividly, often in the context of the recent Ebola epidemic. ElyséeNouvet and John Pringle from the Humanitarian Health Ethics Group , in particular, drew on their ongoing research in Sierra Leone to present the experiences of those directly involved in research during the epidemic. The message that emerged very powerfully from their presentations was that of research as a ‘humanitarian act’ as well as a scientific endeavour. In the experience of their informants, research and care inevitably became blurred within a global health emergency where all interventions required rapid adaptation and innovation.
Bringing together the regulatory and ethical domains
The concept of research that may ‘offer the possibility of clinical benefit’ is well established. Yet, despite this recognition, those working within ‘research’ and ‘treatment’ environments operate in distinct regulatory and ethical domains, not least in order to emphasise the differential focus on ‘learning for the future’ as opposed to care of the individual patient.
Attempts to bring these domains together to respond as effectively and humanely as possible in situations where uncertainty reigns, may lead to accusations of ‘cutting corners’ – a shorthand for allegations of unethical action. And indeed, in responding to the magnitude of need and sense of desperation engendered by emergencies, the risks of unethical action are clearly present. The challenge is how to recognise and minimise those risks without at the same time losing the opportunity for beneficial action.
The Nuffield Council is currently considering the role it could play in that endeavour, as part of wider consideration of the ethical challenges of conducting research in a global health emergency alongside the many other facets of humanitarian response. Such analysis could also usefully pay attention to other areas of health-related research where the research and practice boundary is blurred. Examples debated at the Oxford conference included the idea of health research as a tool of development; and the concept of ‘learning healthcare systems’ in health systems research.
Thoughts and reactions from those similarly challenged by the research/practice divide would be warmly received.