This substudy seeks to inform deliberation and resolution of ethical issues related to clinical research in developing countries through empirical data obtained from parents/guardians who enrolled their children in an anti-malarial efficacy study. The anti-malarial study is being conducted at East Africa Network for Monitoring Antimalarial Treatment (EANMAT) sites in Uganda, Rwanda, Tanzania and Kenya and will evaluate the safety and efficacy of LapDap (chlorproguanil/dapsone) plus artesunate for uncomplicated malaria in children aged 3-59 months. It will also compare the efficacy of LapDap to that of sulphadoxine pyrimethamine (SP) plus amodiaquine. The ethics substudy will be conducted at 4 Ugandan sites. Individual interviews have been conducted with more than 300 parents (primarily mothers) of children enrolled in the malaria study. The data has been entered and analysis is underway.
