The Ethical Design of an AIDS Vaccine Trial in Africa

PIP: In 1987 in Zaire, a French investigator and a small group of Zairians were immunized with a French investigational AIDS vaccine. This action leads to questioning whether different sociocultural settings should have different research ethics applied, especially on pandemic diseases. Another question is to clarify the valid reasons for conducting an AIDS trial in Africa. The design of an AIDS vaccine trial should vary with the ethical and cultural factors of the research population involved, even if the epidemiological and scientific factors are the same worldwide. In Africa, study subjects meet the requirements for AIDS research: They are free from HIV infection and are at risk for the infection. However, concerns center on how to keep the subjects free from risks during the 6 months between HIV tests and how to ensure laboratory test accuracy. The applicability of the findings to that population are essential, although they may be unique to Africa. Research subjects must consent to participating in the trial and must be advised of their antibody status and of their becoming seropositive. To increase the beneficent treatment of subjects and decrease the risks, the study size should be increased and all participants should be counseled to avoid risky behaviors. A subject's family or social group may need to give consent in addition to the subject, because of cultural views. The explanation of the research must be in culturally relevant terms. Africa should have fair access to the vaccine resulting from the research. (June 1988)