Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa

Background Clinical trials undertaken by industrialized nations in undeveloped nations pose several critical ethical dilemmas. One key potential problem con-cerns misunderstandings of the consent process by participants. Though other reports have begun to explore this area, needs remain to identify specific areas of misunderstanding. Purpose To identify deficits in comprehension during consent processes in Mali, West Africa. Methods After obtaining informed consent for participation for a malaria vaccine trial being conducted in two West African villages, we administered to participants a nine-item questionnaire testing their understanding of information relevant for their consent. After testing their ability to understand a multiple choice format, 78 of 100 subjects were administered the questionnaire in one village and 85 of 100 in the other. Results Participants had difficulty comprehending several concepts relevant to informed consent: 90 % of respondents did not understand withdrawal criterion, 93 % did not understand the existence of study side effects, and 74 % did no