Community engagement & ethical practice in vaccine research

Community Engagement (CE) is often presented by bio-ethicists and scientists as a straightforward and unequivocal good which can help to minimize the risks of exploitation, ensure a fair distribution of research benefits and improve the quality of informed consent in the conduct of health research in developing countries. The main objective of my thesis is to critically analyse the relationship between CE and ethical practice in vaccine research. I do this by drawing on ethnographic fieldwork undertaken between 2007 and 2009. In my fieldwork I explored how CE is understood, talked about and enacted in two paediatric vaccine trials conducted by a collaborative partnership between the Kenyan Medical Research Institute and the US Centers for Disease Control (KEMRI/CDC) in Western Kenya. The first 3 chapters of my thesis contain introductory material. Chapter 1 describes the geographic and institutional context of my fieldwork and provides a summary of the paediatric vaccine trials. It also documents my conceptual framework with reference to relevant literature. Chapter 2 provides an overview of the history of immunization and related research in Sub-Saharan African, with a particular focus on East Africa. In chapter 3 describe my ethnographic research design and provide a detailed account of my fieldwork, methods and data analysis. 122 people from the following groups consented to participate in this study: 1) KEMRI/CDC Staff Members (n=18), 2) Community Representatives (e. g. Village Reporters (VRs), Community Advisory Board (CAB), Government & Political Gatekeepers) (n=71), 3) Parents/Guardians of Vaccine Trial Participants (n=20), and 4) Other Community Members (n=7). With the support of 3 Kenyan research assistants I observed CE related activities, compiled field notes and conducted 83 semi-structured interviews and 7 focus group discussions. The 8 findings chapters are grouped as follows: 1) 'The Historical Emergence & Framing of Community Engagement' (Ch. 4-5); 2) 'The Social Construction of Community Engagement' (Ch. 6-9); and 3) 'Responses and Negotiations in Community Engagement' (Ch. 10-11). 3 1) Between the years of 1979-2009 the KEMRI/CDC research programme grew from involvement in community-led health projects into a global enterprise. This inevitably resulted in changes in the control and direction of interactions between researchers and community members. The contemporary framing of CE relies heavily on researchers teaching laypeople about science. 2) The concept of 'positioning' is critical to the contemporary social construction of CE. KEMRI/CDC's primary goal is to convey accurate messages, present a positive image and demonstrate 'attachment' to the local community. VRs' (paid volunteers) smooth the passage of research but find it difficult to balance allegiances, and respond to local expectations for material assistance. CAB members function as KEMRI/CDC patron-clients rather than community advocates, and Gatekeepers argue that a research agenda cannot be applied without accounting for inadequate district health services. 3) Increasing interactions between KEMRI/CDC and the community have helped address inherent cultural suspicions about research, thereby diverting attention to the benefits of trial participation. Hence questions of exclusion rather than inclusion have started to dominate discussions during CE activities. When it comes to engagements in public health facilities attention is focussed on how to balance differences between two paradigms of care-giving; namely 1) 'research' and 'general' care. In chapter 12 I synthesize my findings and argue that far from being an unproblematic good CE offers a lens into new and pre-existing inequalities which affect the implementation of research in resource-limited settings. CE emerges from my data as highly complex and challenging work, which requires continuous efforts and cannot be limited simply to information exchange. In order to address the tensions and contradictions which arise in CE it is essential to discuss questions of social justice and to engage materially, through a broader distribution of resources, with the community where research takes place.