Strengthening the informed consent process in international health research through community engagement: The KEMRI-Wellcome Trust Research Programme Experience.

Informed consent is fundamental to ethical health research. However, significant challenges are experienced worldwide in ensuring regulatory and practical requirements for informed consent are met [1–4]. These challenges are partly attributable to differences in the understanding of research concepts and processes between researchers and research participants, differences that are most acute where there are large gaps between these groups in access to resources, literacy levels, and perceptions of health and illness, and in contexts where access to biomedical health care is severely constrained [1,5]. This paper describes a programmatic approach to strengthening consent processes in a low resource setting and aims to contribute to global dialogue on practical ways of strengthening informed consent processes for health research. The Kenya Medical Research Institute (KEMRI)-Wellcome Trust Research Programme (KWTRP) in Kilifi, Kenya, is a collaborative multidisciplinary research programme established in 1979 that focuses on the major causes of ill health in Kenya and sub-Saharan Africa. The Programme faces many of the challenges mentioned above. Studies in the area on community perceptions [1,6–9] and institutional experiences of community engagement in research [10,11] have highlighted a number of issues that undermine informed consent processes, including: