Abstract
Background: Human infection studies (HIS) involve deliberately infecting healthy volunteers with a pathogen in a controlled environment to understand infection and support the development of effective vaccines or treatments. HIS research is expanding to many low and middle-income settings to accelerate vaccine development. Given the implementation of the first HIS research to establish the experimental human pneumococcal carriage model's feasibility, we sought to understand the participant's opinions and experiences. Methods: We used a qualitative, descriptive approach to understand participants perceptions and experiences on HIS participation. Sixteen healthy adult participants were invited to participate in in-depth exit interviews to discuss their experiences, motivations and concerns. Results: Our findings showed that the likelihood of participation in HIS research rests on three essential conditions: motivation to participate, compensation and advocacy. The motivation and decision to participate was based on reasons including altruism, patriotism, monetary and material incentives, and while compensation was deemed appropriate, concerns about unanticipated research-related risks were raised. Participant advocate groups were recommended for increasing awareness and educating others in the broader community about HIS research. Conclusions: Participants' experiences of HIS in Malawi provide the basis of what can be acceptable in HIS research in lower-income countries and areas where study procedures could be adjusted.
Highlights
Human infection studies (HIS) or controlled human infection models (CHIM) often involve deliberately infecting healthy adult student volunteers with a pathogen in a controlled environment to better understand infection and support the development of effective vaccines or treatments[1]
The ethical issues may be more amplified in low and middle-income countries (LMICs), they do not differ significantly from the ethical issues raised by CHIM in high-income countries[14]
Findings will inform regulatory thinking on guidelines, frameworks and principles on how ethics review committees in Malawi should handle the governance of CHIMs
Summary
Human infection studies (HIS) or controlled human infection models (CHIM) often involve deliberately infecting healthy adult student volunteers with a pathogen in a controlled environment to better understand infection and support the development of effective vaccines or treatments[1]. Plans to conduct CHIM in other settings such as India[8], Vietnam[9], Uganda[10], Malawi[11], to name a few, are underway to explore the acceleration of vaccine development relevant to LMIC populations. Other authors argue that these concerns are not unique to LMICs. the ethical issues may be more amplified in LMICs, they do not differ significantly from the ethical issues raised by CHIM in high-income countries[14]. Human infection studies (HIS) involve deliberately infecting healthy volunteers with a pathogen in a controlled environment to understand infection and support the development of effective vaccines or treatments. Conclusions: Participants’ experiences of HIS in Malawi provide the basis of what can be acceptable in HIS research in lower-income countries and areas where study procedures could be adjusted
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