Cluster randomized trial assessing the effects of rapid ethical assessment on informed consent comprehension in a low-resource setting

摘要

BackgroundMaximizing comprehension is a major challenge for informed consent processes in low-literacy and resource-limited settings. Application of rapid qualitative assessments to improve the informed consent process is increasingly considered useful. This study assessed the effects of Rapid Ethical Assessment (REA) on comprehension, retention and quality of the informed consent process.