Practical Experiences in Obtaining Informed Consent for a Vaccine Trial in Rural Africa

Abstract

The Helsinki Declaration outlines clear ethical principles, including the basic concepts of informed consent, for physicians conducting biomedical research. There are guidelines for applying those principles specifically in research conducted in developing countries.¹⁴ One guideline allows a community-based approach to enrollment, according to which the decision whether or not to participate can be elicited through an intermediary, such as a trusted community leader, who helps convey information about the research to the people in the community.¹ There is considerable debate about the appropriateness of obtaining individual informed consent in non-Western cultures.⁵⁸ In the process of conducting a study . . .