Abstract
BackgroundHuman infection studies (HIS) that involve deliberately infecting healthy volunteers with a pathogen raise important ethical issues, including the need to ensure that benefits and burdens are understood and appropriately accounted for. Building on earlier work, we embedded social science research within an ongoing malaria human infection study in coastal Kenya to understand the study benefits and burdens experienced by study stakeholders in this low-resource setting and assess the wider implications for future research planning and policy.MethodsData were collected using qualitative research methods, including in-depth interviews (44), focus group discussions (10) and non-participation observation. Study participants were purposively selected (key informant or maximal diversity sampling), including volunteers in the human infection study, study staff, community representatives and local administrative authorities. Data were collected during and up to 18 months following study residency, from sites in Coastal and Western Kenya. Voice recordings of interviews and discussions were transcribed, translated, and analysed using framework analysis, combining data- and theory-driven perspectives.FindingsPhysical, psychological, economic and social forms of benefits and burdens were experienced across study stages. Important benefits for volunteers included the study compensation, access to health checks, good residential living conditions, new learning opportunities, developing friendships and satisfaction at contributing towards a new malaria vaccine. Burdens primarily affected study volunteers, including experiences of discomfort and ill health; fear and anxiety around aspects of the trial process, particularly deliberate infection and the implications of prolonged residency; anxieties about early residency exit; and interpersonal conflict. These issues had important implications for volunteers’ families, study staff and the research institution’s reputation more widely.ConclusionDeveloping ethically and scientifically strong HIS relies on grounded accounts of volunteers, study staff and the wider community, understood in the socioeconomic, political and cultural context where studies are implemented. Recognition of the diverse, and sometimes perverse, nature of potential benefits and burdens in a given context, and who this might implicate, is critical to this process. Prior and ongoing stakeholder engagement is core to developing these insights.
Highlights
Human infection studies (HIS) that involve deliberately infecting healthy volunteers with a pathogen raise important ethical issues, including the need to ensure that benefits and burdens are understood and appropriately accounted for
Since HIS tend to involve fewer participants in a controlled environment — in contrast to large-scale clinical trials — they can be conducted over shorter durations and support the testing of several candidate vaccines or drug products, translating to substantial cost-saving in vaccine and drug development initiatives
Levels of compensation were tied to the number of days spent in residency during the Malaria HIS (mHIS), with early exits prompted by episodes of clinical malaria requiring treatment
Summary
Human infection studies (HIS) that involve deliberately infecting healthy volunteers with a pathogen raise important ethical issues, including the need to ensure that benefits and burdens are understood and appropriately accounted for. Of direct relevance to this paper, HIS are seen to have particular social value (including translational benefits) in settings where target diseases are endemic, since research populations are likely to have similar genetic and immunological profiles as a future target population. In these settings, prior exposure may be associated with less severe symptoms and the illness seen as an ‘everyday occurrence’ [5, 6]. This recent increase in the number of HIS in LMICs may be associated with advances in research infrastructure, technical expertise and clinical facilities; more accommodating ethics and regulatory environment; and changing cultural norms [12]
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