When the science fails and the ethics works: ‘Fail-safe’ ethics in the FEM-PrEP study

Abstract

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arguments are increasingly deployed to mobilise, maintain and in some cases stop trials in ways which, at times, are superseded or co-opted by other interests.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.

Keywords:

• failure
• fieldworkers
• PrEP
• women
• Africa

Acknowledgements

The author would to thank the frontline research workers for giving of their time and sharing their valuable experiences and insights. The author would also like to thank the two reviewers for their constructive comments on earlier versions of the manuscript. Responsibility for the arguments made in the article remains, however, with the author alone.

Ethics Approval

This study of frontline research workers involved gaining multi-institutional ethics approval. Ethical approval was sought from seven different institutions, which included the author's UK-based academic institutions and national ethical boards in the respective countries. Furthermore, permission was sought from frontline workers and their line managers (e.g. Principal Investigators) involved in research projects, and in the case of FEM-PrEP also from FHI 360, one of the funders of the trial.

Disclosure statement

No potential conflict of interest was reported by the author.

Additional information

Funding

The data presented in this article were generously supported by the Wellcome Trust Society and Ethics Funding Scheme (WT080546MF).