The informed consent process in a rural African setting: a case study of the Kassena-Nankana district of Northern Ghana.

Abstract

A PUBLICATION OF THE HASTINGS CENTER International regulations and guidelines for human subjects research emphasize that investigators must obtain voluntary informed consent from each research participant. Many research ethics committees require written informed consent and the use of a consent form, which describes the purpose and procedures of the study and its potential risks and benefits of participation; explains that participation is voluntary and that subjects can withdraw at any time; and provides information about maintaining subject privacy and confidentiality of research data. Consent forms and other information provided to participants should be in a language understandable to the participant or to the parent or guardian if the participant is a child.2 Yet an individual-based consent model and the use of written consent documents may be problematic in countries where norms of decision-making do not emphasize individual autonomy and where there are nonliterate populations. Thus, several guidelines and reports on research ethics endorse the use of community approval and verbal consent for research in countries where cultural values and practices emphasize oral rather than written agree-