A qualitative study using traditional community assemblies to investigate community perspectives on informed consent and research participation in western Kenya.

Rachel Vreeman,Lukoye Atwoli,Allan Kamanda,David Ayuku,Eunice Kamaara,Samuel Ayaya,Michael Scanlon,Paula Braitstein,Peter Gisore,Winstone Nyandiko

doi:10.1186/1472-6939-13-23

Abstract

BackgroundInternational collaborators face challenges in the design and implementation of ethical biomedical research. Evaluating community understanding of research and processes like informed consent may enable researchers to better protect research participants in a particular setting; however, there exist few studies examining community perspectives in health research, particularly in resource-limited settings, or strategies for engaging the community in research processes. Our goal was to inform ethical research practice in a biomedical research setting in western Kenya and similar resource-limited settings.MethodsWe sought to use mabaraza, traditional East African community assemblies, in a qualitative study to understand community perspectives on biomedical research and informed consent within a collaborative, multinational research network in western Kenya. Analyses included manual, progressive coding of transcripts from mabaraza to identify emerging central concepts.ResultsOur findings from two mabaraza with 108 community members revealed that, while participants understood some principles of biomedical research, they emphasized perceived benefits from participation in research over potential risks. Many community members equated health research with HIV testing or care, which may be explained in part by the setting of this particular study. In addition to valuing informed consent as understanding and accepting a role in research activities, participants endorsed an increased role for the community in making decisions about research participation, especially in the case of children, through a process of community consent.ConclusionsOur study suggests that international biomedical research must account for community understanding of research and informed consent, particularly when involving children. Moreover, traditional community forums, such as mabaraza in East Africa, can be used effectively to gather these data and may serve as a forum to further engage communities in community consent and other aspects of research.

Highlights

International collaborators face challenges in the design and implementation of ethical biomedical research
Examining community members’ understanding of research and informed consent within a multinational research collaboration in Kenya provides insight into how community engagement might be strengthened in similar settings
While community members generally understood the concepts of research and informed consent, their emphasis on the benefits reaped from research participation and their equating of research with HIV testing or care could inform education around topics such as research risks

Summary

Introduction

International collaborators face challenges in the design and implementation of ethical biomedical research. Evaluating community understanding of research and processes like informed consent may enable researchers to better protect research participants in a particular setting; there exist few studies examining community perspectives in health research, in resource-limited settings, or strategies for engaging the community in research processes. Several factors may increase the vulnerability of individuals and communities participating in research, including, lower socioeconomic status, less experience with and understanding of biomedical research, and poor availability and accessibility of health services [12]. Because these vulnerabilities may be prominent in resource-limited communities, additional mechanisms for ensuring adequate protection for research participants should be considered [4]. Involving communities in aspects of research activities like protocol development and research conduct can lead to greater protections for communities and individual participants [15,16], but little empirical data inform the best practices and models of community engagement for research in sub-Saharan Africa [17,18]

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