Ensuring informed, autonomous, and voluntary participation of subjects in clinical research remains a challenge in sub-Saharan Africa. Sociocultural, economic and historical factors influence the perception and understanding of such studies, affecting subjects’ consent. Vaccine trials present additional challenges, as they depend on people’s prior knowledge of disease prevention and vaccination programmes.

The project seeks to improve information and consent processes for participation in vaccine trials across sub-Saharan Africa. This project offers a community- and participant-centred approach which considers subjects’ needs, values, and preferences as well as the methods used in previous vaccine trials.

This study is divided into three phases. Phase One involves a literature review to identify studies on information and consent processes in vaccine trials. Phase Two is a qualitative study enabling a description of current practices. Phase Three will explore the use of a participant- and community-centred approach in the design of these processes. The grant focuses on the first two phases of the project.