Abstract:
Background: The range and amount of volunteer infection studies, known as Controlled
Human Infection Model (CHMI) studies, in Low-Middle Income Countries (LMICs) is
increasing with rapid technological advancement, world-class laboratory facilities and
increasing capacity development initiatives. However, the ethical issues these studies
present in LMICs have not been empirically studied. We present findings of a descriptive
social science study nested within a malaria volunteer infection study, on-going at the
time of writing, at the KEMRI-Wellcome Trust Research Programme (KWTRP) on the
Kenyan Coast. Methods: The study included non-participant observations, five group
discussions with more than half of the CHMI study participants, two in-depth interviews
with study team members, and an exit questionnaire administered to the participants.
Results: Participants understood the key elements of the study, including that they would
be deliberately infected with malaria parasites and may get malaria as a result, there
would be regular blood draws, and they would spend up to 24 days in a residence facility
away from their homes. The greatest motivation for participation was the monetary
compensation of 20 USD per overnight stay given as a lump-sum at the end of their
residency stay. Also appreciated were the health screening tests prior to enrolment and
the positive relations with the study team. Concerns raised included the amount and
regularity of blood draws experienced, and concerns that this type of research may feed
into on-going rumours about research generally. Conclusion: With the increasing range
and number of CHMI studies being conducted in LMICs, current ethical guidance are
inadequate. This study highlights some of the ethical issues that could emerge in these
settings, emphasizing the heavy responsibility placed on research review and regulatory
systems, researchers and funders, as well as the importance of carefully tailored
community engagement and consent processes.