This protocol has been approved by the NIAID IRB. 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 the 4 Ugandan sites. Its primary methodology is individual interviews, and a secondary methodology is focus group discussions.

Agency
National Institute of Health (NIH)
Institute
Clinical Center (CLC)
Type
Intramural Research (Z01)
Project #
1Z01CL010520-01
Application #
6683890
Study Section
Cell Biology Integrated Review Group (CB)
Project Start
Project End
Budget Start
Budget End
Support Year
1
Fiscal Year
2002
Total Cost
Indirect Cost
Name
Clinical Center
Department
Type
DUNS #
City
State
Country
United States
Zip Code