Ethical implications of malaria vaccine development

Abstract

Clinical trials conducted in low-resource settings have unique challenges associated with their conduct. This is mainly attributed to the power and resource discrepancy between actors in the clinical trial. This thesis provides an in-depth look at clinical trials in low-resource settings and the effects of the resource discrepancy on the actors. It aims to answer what the ethical challenges are when conducting research in low-resource settings and the subsequent implications for research design. It focuses on capturing both the experience of caregivers of pediatric participants and the frontline researchers in a malaria vaccine clinical trial. Through exploring these two stories and bridging the relational with the formal, it provides a novel approach to address the challenges with research in low-resource settings. This approach employs the lens of complexity theory to evaluate the outcome of two systems, a human community and a clinical trial, merging. I will begin by outlining a general introduction of clinical trials in low-resource settings and the case study of a pediatric malaria vaccine clinical trial, here I detail the need to generate a vaccine against malaria and outline why such research should take place. This situates the reasons for the study and provides familiarity with the contextual reality. Then I will move into detailing the caregiver experiences, researcher experiences, and the application of complexity theory to bridge together the different experiences. This thesis is a result of qualitative data gathered from 78 interviews with caregivers of pediatric participants and 11 interviews with researchers involved on the frontline of a pediatric malaria vaccine clinical trial. The final part of the thesis is a theoretical reflection that explores the realities faced by researchers and argues for an approach that embraces the non-linearity of research taking place in human communities. Here I identify the challenges associated with choice and structural inequity, the conflict between beneficence and autonomy, and being a frontline researcher in low-resource settings.