When the science fails and the ethics works: 'Fail-safe' ethics in the FEM-PrEP study.

This paper will explore the concept of 'fail safe' ethics in the FEM PrEP trial, and the practice of research and ethics on the ground. FEM-PrEP examined the efficacy of PrEP in African women after promising outcomes in research conducted with MSM. This was a hugely optimistic time and FEM-PrEP was mobilised using rights-based ethical arguments that women should have access to PrEP. This paper will present data collected during an ethnographic study of frontline research workers involved in FEM-PrEP. During our discussions, 'fail-safe' ethics emerged as concept that encapsulated their confidence that their ethics could not fail. However, in 2011, FEM-PrEP was halted and deemed a failure. The women involved in the study were held responsible because contrary to researcher's expectations they were not taking the oral PrEP being researched. This examination of FEM-PrEP will show that ethical arguments are increasingly deployed to mobilise, maintain and in some cases stop trials in ways which, at times, are superseded or co-opted by other interests. While promoting the interests of women, rights-based approaches are argued to indirectly justify the continuation of individualised, biomedical interventions which have been problematic in other women-centred trials. In this examination of FEM-PrEP, the rights-based approach obscured: ethical concerns beyond access to PrEP; the complexities of power relationships between donor and host countries; the operations of the HIV industry in research-saturated areas and the cumulative effect of unfilled expectations in HIV research and how this has shaped ideas of research and ethics.