Comparing the Understanding of Subjects receiving a Candidate Malaria Vaccine in the United States and Mali
R. D. Ellis, I. Sagara, A. Durbin, A. Dicko, D. Shaffer, L. Miller, M. H. Assadou, M. Kone, B. Kamate, O. Guindo, M. P. Fay, D. A. Diallo, O. K. Doumbo, E. J. Emanuel & J. Millum
American Journal of Tropical Medicine and Hygiene 83 (4):868-72 (2010)
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In medical research, the ethical principle of respect for persons is operationalized into the process of informed consent. The consent tools should be contextualized and adapted to the different socio-cultural environment, especially when research crosses the traditional boundaries and reaches poor communities. We look at the challenges experienced in the malaria Quinact trial, conducted in the Democratic Republic of Congo, and describe some lessons learned, related to the definition of acceptable representative, the role of independent witness and the impact of (...)