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 concerns misunderstandings of the consent process by participants. Though other reports have begun to explore this area, needs remain to identify specific areas of misunderstanding.


OBJECTIVE
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 not understand that they were enrolled in an investigation as opposed to receiving therapy. The response rate and percentage of correct answers was generally much higher in the village nearer an urban center than the more rural village. The percent of correct answers exceeded 50% for five questions in the urban village and for only two question in the more rural setting.


CONCLUSIONS
Potential limitations of this study are relating to translation, cultural differences in the notion of informed consent, staff differences between each village, the proportion who could not understand the survey instrument and the fact that the study explored participants' understanding of the consent process but did not observe the process itself.


CONCLUSIONS
This study illustrates potential areas of miscomprehension in the consent process in a developing country. The degree of miscomprehension found in this study appeared to be more than that found in similar studies conducted in industrialized nations. Despite efforts to obtain truly informed consent, several factors make it more challenging in the developing world. This research highlights the need for more comprehensive studies of consent in developing countries. Such studies may eventually aid investigators in identifying, targeting and addressing specific areas of miscomprehension and thereby improve the informed consent process in the developing world.
Krosin
Michael T
MT
San Francisco Orthopedic Program at St. Mary's Medical Center, San Francisco, CA, USA. mkrosin@hotmail.com
Klitzman
Robert
R
Levin
Bruce
B
Cheng
Jianfeng
J
Ranney
Megan L
ML
D016009:Chi-Square Distribution; D002986:Clinical Trials as Topic / Q000941:ethics / Q000592:standards*; D032882:Comprehension; D003466:Cultural Characteristics; D003906:Developing Countries; D005260:Female; D006801:Humans; D007258:Informed Consent; D008288:Malaria / Q000517:prevention & control*; D017780:Malaria Vaccines / Q000627:therapeutic use*; D008297:Male; D008302:Mali; D012424:Rural Population; D013383:Suburban Population; D011795:Surveys and Questionnaires; D014177:Translations
D017780:Malaria Vaccines