Ethical perspective on malaria research for Africa.

Malaria is a leading cause of death and illness in Africa, afflicting mainly young children, infants and young pregnant women, especially in rural areas where access to health services is often limited. Resistance to the safest and most affordable antimalarials, the threat of insecticide resistance, demand for research and development of new malaria treatment, prevention and control tools in the form of new antimalarials, vaccines, diagnostics, insecticides and devices. New antimalarial tools must be tested on the most afflicted groups (young children, infants and pregnant women) whose autonomy especially in tradition African rural settings is severely impaired or diminished. They, therefore, deserve special protection by the researcher; thorough ethical review ensuring genuine informed consent is therefore crucial. The testing of new products, particularly with novel vaccine formulations and new adjuvants in the vulnerable groups, age de-escalation, trial of transmission blocking vaccines, the initial testing (Phases Ia and IIa) of vaccines and drugs in non-endemic populations all pose ethical dilemmas, as do bioprospecting (biopiracy) and the standard of care during and after the research. Besides these concerns, ethical issues relating to epidemiological research are also addressed.