A quantitative evaluation of the quality of informed consent in a developing country setting

Includes bibliographical references (leaves 59-62).Informed consent is an ethical and legal requirement for research involving human participants. However, there have been few studies that have evaluated the process, particularly in an African setting. In addition, standardized methods for assessing the quality of informed consent are not available in the literature. The aim of the study was to evaluate the quality of consent in a large tuberculosis vaccine immunology study and to identify factors associated with the quality of consent