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)

Drug exceptional access programs (DEAPs) exist across Canada to address gaps in access to pharmaceuticals. These programs circumvent standard procedures, raising epistemic, economic, social and political issues. This commentary provides insights into these issues by revealing the context and procedures on which these programs depend.

Fragile states have been raising increasing concern among donors since the mid-2000s. The policies of the Global Fund to fight HIV/AIDS, Malaria, and Tuberculosis have not excluded fragile states, and this source has provided financing for these countries according to standardized procedures. They represent interesting cases for exploring the meaning and role of measurement in a globalized context. Measurement in the field of HIV/AIDS and its treatment has given rise to a private outsourcing of expertise and auditing, thereby creating a (...) new form of value based on the social process of registration and the creation of realities produced by the intervention itself. These “scriptural economies” must be questioned in terms of the production of knowledge, but also in terms of social justice. Governing HIV/AIDS treatments by numbers in a fragile state is explored in this article through the experience of the Central African Republic in terms of epidemiology and access to antiretroviral drugs. The unexpected effects of performance-based programs in this context underline the need for global health governance to be re-embedded into a social justice framework. (shrink)

An amendment to this paper has been published and can be accessed via the original article.