title: Comparing the understanding of subjects receiving a candidate malaria vaccine in the United States and Mali.
abstract: Initial responses to questionnaires used to assess participants' understanding of informed consent for malaria vaccine trials conducted in the United States and Mali were tallied. Total scores were analyzed by age, sex, literacy (if known), and location. Ninety-two percent (92%) of answers by United States participants and 85% of answers by Malian participants were correct. Questions more likely to be answered incorrectly in Mali related to risk, and to the type of vaccine. For adult participants, independent predictors of higher scores were younger age and female sex in the United States, and male sex in Mali. Scores in the United States were higher than in Mali (P = 0.005). Despite this difference participants at both sites were well informed overall. Although interpretation must be qualified because questionnaires were not intended as research tools and were not standardized among sites, these results do not support concerns about systematic low understanding among research participants in developing versus developed countries.
authors.affiliation: Malaria Vaccine Development Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland 20892, USA. ellisru@niaid.nih.gov
authors.forename: Ruth D
authors.initials: RD
authors.lastname: Ellis
authors.forename: Issaka
authors.initials: I
authors.lastname: Sagara
authors.forename: Anna
authors.initials: A
authors.lastname: Durbin
authors.forename: Alassane
authors.initials: A
authors.lastname: Dicko
authors.forename: Donna
authors.initials: D
authors.lastname: Shaffer
authors.forename: Louis
authors.initials: L
authors.lastname: Miller
authors.forename: Mahamadoun H
authors.initials: MH
authors.lastname: Assadou
authors.forename: Mamady
authors.initials: M
authors.lastname: Kone
authors.forename: Beh
authors.initials: B
authors.lastname: Kamate
authors.forename: Ousmane
authors.initials: O
authors.lastname: Guindo
authors.forename: Michael P
authors.initials: MP
authors.lastname: Fay
authors.forename: Dapa A
authors.initials: DA
authors.lastname: Diallo
authors.forename: Ogobara K
authors.initials: OK
authors.lastname: Doumbo
authors.forename: Ezekiel J
authors.initials: EJ
authors.lastname: Emanuel
authors.forename: Joseph
authors.initials: J
authors.lastname: Millum
mesh_terms: D000293:Adolescent; D000328:Adult; D032882:Comprehension; D003625:Data Collection; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000523:psychology*; D008288:Malaria / Q000517:prevention & control; D017780:Malaria Vaccines; D008297:Male; D008302:Mali; D008875:Middle Aged; D011795:Surveys and Questionnaires; D014481:United States; D055815:Young Adult
chemical_list: D017780:Malaria Vaccines