Michael Krosin|Robert Klitzman|Bruce Levin|Jianfeng Cheng|Megan L. Ranney
Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa
St. Mary's Medical Center|Columbia University
background clinical trials undertaken industrialized nations undeveloped nations pose several critical ethical dilemmas one key potential problem concerns misunderstandings consent process participants though reports begun explore area needs remain identify specific areas misunderstanding purpose identify deficits comprehension consent processes mali west africa methods obtaining informed consent participation malaria vaccine trial conducted two west african villages administered participants nineitem questionnaire testing understanding information relevant consent testing ability understand multiple choice format 78 100 subjects administered questionnaire one village 85 100 results participants difficulty comprehending several concepts relevant informed consent 90 respondents understand withdrawal criterion 93 understand existence study side effects 74 understand enrolled investigation opposed receiving therapy response rate percentage correct answers generally much higher village nearer urban center rural village percent correct answers exceeded 50 five questions urban village two question rural setting limitations potential limitations study relating translation cultural differences notion informed consent staff differences village proportion could understand survey instrument fact study explored participants understanding consent process observe process conclusions study illustrates potential areas miscomprehension consent process developing country degree miscomprehension found study appeared found similar studies conducted industrialized nations despite efforts obtain truly informed consent several factors make challenging developing world research highlights need comprehensive studies consent developing countries studies may eventually aid investigators identifying targeting addressing specific areas miscomprehension thereby improve informed consent process developing world