The Ebola clinical trials: a precedent for research ethics in disasters

Abstract

The West African Ebola epidemic has set in motion a collective endeavour to conduct accelerated clinical trials, testing unproven but potentially lifesaving interventions in the course of a major public health crisis. This unprecedented effort was supported by the recommendations of an ad hoc ethics panel convened in August 2014 by the WHO. By considering why and on what conditions the exceptional circumstances of the Ebola epidemic justified the use of unproven interventions, the panel's recommendations have challenged conventional thinking about therapeutic development and clinical research ethics. At the same time, unanswered ethical questions have emerged, in particular: (i) the specification of exceptional circumstances, (ii) the specification of unproven interventions, (iii) the goals of interventional research in terms of individual versus collective interests, (iv) the place of adaptive trial designs and (v) the exact meaning of compassionate use with unapproved interventions. Examination of these questions, in parallel with empirical data from research sites, will help build pragmatic foundations for disaster research ethics. Furthermore, the Ebola clinical trials signal an evolution in the current paradigms of therapeutic research, beyond the case of epidemic emergencies.

Individual and public interests in clinical research during epidemics: a reply to Calain

“…In his stimulating target article,1 Philippe Calain discusses how the traditional ethical framework for clinical research was challenged during the 2013–2016 Ebola epidemic in West Africa. One of his key claims is that conventional research ethics did not have the resources to address the ‘profound tension’1 (p.3) , between individual and public interests in clinical research during this epidemic.…”

“…One of his key claims is that conventional research ethics did not have the resources to address the ‘profound tension’1 (p.3) , between individual and public interests in clinical research during this epidemic. I agree with this claim, but would like to provide a modified argument in its support.…”

“…In his view, conventional research ethics adopts a ‘public health perspective of clinical trials’ that puts ‘social value above individual interests’ and views ‘public health and patient care … [as] opposed’ 1 . (p.3) This perspective, he argues, was unable to reconcile individual and public interests in research during the 2013–2016 epidemic.…”

Aspects of disaster research ethics applicable to other contexts

“…In his article ‘The Ebola Clinical Trials: a precedent for research ethics in disasters’, Philippe Calain1 constructs a compelling case as to why and how experiences from the recent Ebola epidemic should be used to develop a framework for disaster research ethics. In particular, Calain1 proposes a useful model for assessing whether or not an unproven intervention could be suitable for human use in a disaster context, and makes a powerful argument against the separation of patient care from research goals.…”

“…In particular, Calain1 proposes a useful model for assessing whether or not an unproven intervention could be suitable for human use in a disaster context, and makes a powerful argument against the separation of patient care from research goals. A key question his paper raises is, to what extent are the lessons learned from this epidemic uniquely applicable to infectious disease emergencies, or are there grounds to extrapolate more broadly?…”