Understanding the benefits and burdens associated with a malaria human infection study in Kenya: experiences of study volunteers and other stakeholders

Abstract Background Human infection studies (HIS) that involve deliberately infecting healthy volunteers with a pathogen raise important ethical issues, including the need to ensure benefits and burdens are understood appropriately accounted for. Building on earlier work, we embedded social science research within an ongoing malaria human study in coastal Kenya understand experienced by stakeholders this low-resource setting assess wider implications for future planning policy. Methods Data were collected using qualitative methods, in-depth interviews (44), focus group discussions (10) non-participation observation. Study participants purposively selected (key informant or maximal diversity sampling), study, staff, community representatives local administrative authorities. during up 18 months following residency, from sites Coastal Western Kenya. Voice recordings of transcribed, translated, analysed framework analysis, combining data- theory-driven perspectives. Findings Physical, psychological, economic forms across stages. Important included compensation, access health checks, good residential living conditions, new learning opportunities, developing friendships satisfaction at contributing towards vaccine. Burdens primarily affected volunteers, experiences discomfort ill health; fear anxiety around aspects trial process, particularly deliberate prolonged residency; anxieties about early residency exit; interpersonal conflict. These issues had volunteers’ families, staff institution’s reputation more widely. Conclusion Developing ethically scientifically strong HIS relies grounded accounts community, socioeconomic, political cultural context where implemented. Recognition diverse, sometimes perverse, nature potential given context, who might implicate, is critical process. Prior stakeholder engagement core these insights.