Community permission for medical research in developing countries.

The realization of the need for community consent, or more accurately community permission, for research has occurred relatively recently. Practical experience with it is scarce. This article describes the Malian experience at a malaria vaccine study site. We describe a process that we used to obtain community permission. The process had 6 steps: (1) a study of the community, (2) an introductory meeting with leaders, (3) formal meetings with leaders, (4) personal visits with leaders, (5) meetings with traditional health practitioners, and (6) recognition that obtaining permission is a dynamic process. We discuss documentation of community permission for research and outline the reasons why the community-level process we used was practically necessary and ethically appropriate. Far from competing with the individual informed consent process, the process of obtaining community permission both initiated and facilitated the process of disclosure for individual informed consent.