The recent Ebola virus disease outbreak in Western African countries has raised questions regarding the feasibility of adopting conventional trial designs such as randomized controlled trials for conducting experimental trials in the midst of a fatal epidemic. In the context of Ebola ça Suffit trial conducted in Guinea for testing the efficacy and effectiveness of rVSV–ZEBOV, a candidate vaccine, I argue that the trial design and the methodologies adopted for the trial have been rightly chosen for their ethical appropriateness and (...) social utilities rather than only epistemic advantages. In this paper, I propose and defend the view that in varying scientific research contexts, it is entirely legitimate that non-epistemic values may be prioritized over epistemic considerations. Two vital methodological choices scientists should make while designing a clinical trial are: the choice of appropriate control group and the choice of appropriate randomization. Given this background, I show that the choice of delayed vaccination arm as the control group over placebo control group and the choice of cluster randomization over individually controlled randomization for conducting Ebola ça Suffit trial are perfect instances of such a scenario where addressing social and ethical issues have been justifiably prioritized over epistemic values so that the research in a specific scientific context could be conducted in a socially relevant manner. (shrink)

BackgroundLittle is known about volunteers from Northern research settings who participate in vaccine trials of highly infectious diseases with no approved treatments. This article explores the motivations of HIV immunocompromised study participants in Canada who volunteered in a Phase II clinical trial that evaluated the safety and immunogenicity of an Ebola vaccine candidate.MethodsObservation at the clinical study site and semi-structured interviews employing situational and discursive analysis were conducted with clinical trial participants and staff over one year. Interviews were recorded, transcribed (...) and analysed using critical qualitative interpretivist thematic analytical techniques. Patterns were identified, clustered and sorted to generate distinct and comprehensive themes. We then reassembled events and contexts from the study participants’ stories to develop two ideal portraits based on "composite characters" based on study participants features. These provide ethnographically rich details of participants’ meaningful social worlds while protecting individual identities.ResultsTen of the 14 clinical trial participants, and 3 study staff were interviewed. Participant demographics and socio-economic profiles expressed limited contextual diversity. Half were men who have sex with men, half were former injection drug users experiencing homelessness, one was female, none were racialized minorities and there were no people from HIV endemic countries. Fully 90% had previous involvement in other clinical studies. Their stories point to particular socio-economic situations that motivated their participation as clinical labor through trial participation.ConclusionsOur findings support Fisher’s argument of “structural coercion” in clinical trial recruitment of vulnerable individuals experiencing precarious living conditions. Clinical trials should provide more detail of the structural socio-economic conditions and healthcare needs which lie “under consent” of study participants. Going well beyond an overly convenient narrative of altruism, ethical deliberation frameworks need to sufficiently address the structural conditions of clinical trials. We offer concrete possibilities for this and acknowledge that further research and clinical data should be made available underlying study participant contexts with regards to recruitment and participation in resource poor settings, in both the South and the North. (shrink)