title: 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.
authors: Philippe
authors: P
authors: Calain
mesh_terms: D000354:Africa, Western; D057176:Compassionate Use Trials; D004190:Disasters; D004196:Disease Outbreaks; D026689:Ethical Analysis; D032984:Ethics, Research; D019142:Hemorrhagic Fever, Ebola / Q000453:epidemiology / Q000628:therapy*; D006801:Humans; D011634:Public Health; D012107:Research Design; D036302:Therapeutic Human Experimentation / Q000941:ethics*; D035703:Therapies, Investigational; D000075522:Adaptive Clinical Trials as Topic
keywords: Autonomy; Clinical trials; NGOs; Public Health Ethics; Research Ethics