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Comparing the Understanding of Subjects Receiving a Candidate Malaria Vaccine in the United States and Mali

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  • Malaria Vaccine Development Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland; Malaria Research and Training Center, Faculty of Medicine Pharmacy and Dentistry, University of Bamako, Bamako, Mali; Johns Hopkins Center for Immunization Research, Washington, DC; Biostatistics Research Branch, NIAID/NIH; Clinical Center Department of Bioethics, NIH; Clinical Center Department of Bioethics/Fogarty International Center, NIH, Bethesda, Maryland

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.

Author Notes

*Address correspondence to Joseph Millum, Clinical Center Department of Bioethics/Fogarty International Center, National Institutes of Health Building 10, 1C118 10 Center Drive, Bethesda, MD 20892. E-mail: millumj@cc.nih.gov

Financial support: This research was supported by the Intramural Research Program of the National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIAID).

Authors' addresses: Ruth D. Ellis, Malaria Vaccine Development Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Heath (MVDB, NIAID/NIH), Rockville, MD, E-mail: ellisru@niaid.nih.gov. Issaka Sagara, Alassane Dicko, Mahamadoun H. Assadou, Mamady Kone, Beh Kamate, Ousmane Guindo, Dapa A. Diallo, and Ogobara K Doumbo, Malaria Research and Training Center (MRTC), Department of Epidemiology of Parasitic Diseases, Faculty of Medicine, Pharmacy and Odonto-Stomatology, University of Bamako, Bamako Mali, E-mails: isagara@icermali.org, adicko@icermali.org, mmaiga@icermali.org, mamady@icermali.org, bkamate@icermali.org, guindoous@icermali.org, dadiallo@icermali.org, and okd@icermali.org. Anna Durbin and Donna Shaffer, Johns Hopkins Center for Immunization Research, Washington, DC, E-mails: adurbin@jhsph.edu and dshaffer@jhsph.edu. Louis Miller, MVDB, NIAID/NIH, Rockville, MD, E-mail: lmiller@niaid.nih.gov. Michael P. Fay, Biostatistics Research Branch, NIAID/NIH, Bethesda, MD, E-mail: mfay@niaid.nih.gov. Ezekiel J. Emmanuel, Clinical Center Department of Bioethics, NIH, Bethesda, MD, E-mail: EEmanuel@cc.nih.gov. Joseph Millum, Clinical Center Department of Bioethics/Fogarty International Center, National Institutes of Health, Bethesda, MD, E-mail: millumj@cc.nih.gov.

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