Abstract
Controlled human malaria infection (CHMI) studies involve the deliberate infection of healthy volunteers with malaria parasites under controlled conditions to study immune responses and/or test drug or vaccine efficacy. An empirical ethics study was embedded in a CHMI study at a Kenyan research programme to explore stakeholders’ perceptions and experiences of deliberate infection and moral implications of these. Data for this qualitative study were collected through focus group discussions, in‐depth interviews and non‐participant observation. Sixty‐nine participants were involved, including CHMI study volunteers, community representatives and research staff. Data were managed using QSR Nvivo 10 and analysed using an inductive‐deductive approach, guided by ethics literature. CHMI volunteers had reasonable understanding of the study procedures. Decisions to join were influenced by study incentives, trust in the research institution, their assessment of associated burdens and motivation to support malaria vaccine development. However, deliberate malaria infection was a highly unusual research strategy for volunteers, community representatives and some study staff. Volunteers’ experiences of physical, emotional and social burdens or harms were often greater than anticipated initially, and fluctuated over time, related to specific procedures and events. Although unlikely to deter volunteers' participation in similar studies in furture, we argue that the dissonance between level of understanding of the burdens involved and actual experiences are morally relevant in relation to community engagement, informed consent processes, and ongoing support for volunteers and research staff. We further argue that ethics oversight of CHMI studies should take account of these issues in deciding whether consent, engagement and the balance of benefits and harms are reasonable in a given context.
Highlights
We further argue that ethics oversight of Controlled human malaria infection (CHMI) studies should take account of these issues in deciding whether consent, engagement and the balance of benefits and harms are reasonable in a given context
The concept of deliberate infection core to CHMI is uncommon in practice and unfamiliar to the lay public in low- to middle-income countries (LMICs)
The literature sources acknowledge that deliberate infection carries a risk that unpleasant symptoms and anxieties might be experienced by volunteers, and that the carefully controlled conduct of controlled human infection (CHI) minimises the extent to which harms and discomforts might be experienced
Summary
We aimed to be as reflexive as possible during data collection and analysis about our own potential influences, paying attention to the need to maintain a neutral stance, including probes around counter-points during questioning, ensuring supportive dynamics within group discussion and working as a team to check emerging ideas and consider sources of influence. In future publications we aim to explore these issues in more depth, around decision-making on participation in relation to risks of undue inducement, and forms and levels of physical, social and emotional burdens or harms experienced by volunteers, including longer term follow-up data. In this discussion we aim to underline findings that showed that the fact of being deliberately infected with a disease-causing organism can have an impact on volunteers that may go beyond biomedical understandings of safety but are critical aspects of wellbeing, and have a moral importance for arguments about the acceptability of deliberate infection
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