An AIDS vaccine trial, wherever it is conducted, must be reviewed in at least three different ways before it can proceed. First, a national regulatory authority examines the preclinical data supporting a vaccine’s safety and potential effects, the methods of its production and the clinical trial protocol proposed by researchers. In the smaller countries in Africa, which have limited regulatory capacity, the World Health Organization plays an important advisory role in pre-approving vaccines destined for clinical trials.

Once the trial starts, researchers must report regularly on its progress to these authorities. Second, institutional review boards at the organizations running the trial evaluate the scientific elements of a clinical trial protocol for their validity. Only after a trial has been deemed both scientifically sound and necessary is it permitted to proceed. Finally, an independent ethics committee—unaffiliated with the institutions conducting the trial—reviews both the scientific validity of the proposed study and its adherence to the ethical norms of research done on humans.