There is wide acknowledgement of the need for community engagement in biomedical research, particularly in international settings. Recent debates have described theoretical approaches to identifying situations where this is most critical and potential mechanisms to achieve it. However, there is relatively little published experience of community engagement in practice. A major component of the Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme is centred on Kilifi District General Hospital and surrounding community of 240,000 local residents. Documented community perceptions of the research centre are generally positive, but many indicate a low understanding of research and therapeutic misconceptions of its activities. As in other settings, these misunderstandings have contributed to concerns and rumours, and potentially undermine ethical aspects of research and local trust in the institution. Through a series of consultative activities, a community engagement strategy has been developed in Kilifi to strengthen mutual understanding between community members and the Centre. One important component is the establishment of a representative local resident network in different geographic locations commonly involved in research, to supplement existing communication channels. Early implementation of the strategy has provided new and diverse opportunities for dialogue, interaction and partnership building. Through the complex social interactions inherent in the community engagement strategy, the centre aims to build context specific ethical relations with local residents and to strengthen understanding of how ethical principles can be applied in practice. Evaluations over time will assess the effectiveness and sustainability of these strategies, provide generalisable information for similar research settings, and contribute to debates on the universality of ethical principles for research. This paper aims to summarise the rationale for community engagement in research, drawing on published literature and local findings, to outline the process of community engagement in Kilifi and to describe issues emerging from its development and early implementation.

Individual informed consent is a key ethical obligation for clinical studies, but empirical studies show that key requirements are often not met. Common recommendations to strengthen consent in low income settings include seeking permission from community members through existing structures before approaching individuals, considering informed consent as a process rather than a single event, and assessing participant understanding using questionnaires. In this paper, we report on a qualitative study exploring community understanding and perceptions of a malaria vaccine trial (MVT) conducted in a rural setting on the Kenyan Coast. The MVT incorporated all of the above recommendations into its information-giving processes. The findings support the importance of community level information-giving and of giving information on several different occasions before seeking final individual consent. However, an emerging issue was that inter-personal interactions and relationships between researchers and community members, and within the community, play a critical role in participants' perceptions of a study, their decisions to consent or withdraw, and their advice to researchers on study practicalities and information to feedback at the end of the trial. These relationships are based on and continually tested by information-giving processes, and by context specific concerns and interests that can be difficult to predict and are well beyond the timescale and reach of single research activities. On the basis of these findings, we suggest that the current move towards increasingly ambitious and stringent formal standards for information-giving to individuals be counter-balanced with greater attention to the diverse social relationships that are essential to the successful application of these procedures. This may be assisted by emphasising respecting communities as well as persons, and by recognising that current guidelines and regulations may be an inadequate response to the complex, often unpredictable and ever shifting ethical dilemmas facing research teams working ‘in the field’.

Summarybackground Malaria control in Africa relies primarily on early effective treatment for clinical disease, but most early treatments for fever occur through self-medication with shop-bought drugs. Lack of information to community members on over-the-counter drug use has led to widespread ineffective treatment of fevers, increased risks of drug toxicity and accelerating drug resistance. We examined the feasibility and measured the likely impact of training shop keepers in rural Africa on community drug use.

BackgroundThere is general consensus internationally that unfair distribution of the benefits of research is exploitative and should be avoided or reduced. However, what constitutes fair benefits, and the exact nature of the benefits and their mode of provision can be strongly contested. Empirical studies have the potential to contribute viewpoints and experiences to debates and guidelines, but few have been conducted. We conducted a study to support the development of guidelines on benefits and payments for studies conducted by the KEMRI-Wellcome Trust programme in Kilifi, Kenya.MethodsFollowing an initial broad based survey of cash, health services and other items being offered during research by all programme studies (n = 38 studies), interviews were held with research managers (n = 9), and with research staff involved in 8 purposively selected case studies (n = 30 interviewees). Interviews explored how these ‘benefits’ were selected and communicated, experiences with their administration, and recommendations for future guidelines. Data fed into a consultative workshop attended by 48 research staff and health managers, which was facilitated by an external ethicist.FindingsThe most commonly provided benefits were medical care (for example free care, and strengthened quality of care), and lunch or snacks. Most cash given to participants was reimbursement of transport costs (for example to meet appointments or facilitate use of services when unexpectedly sick), but these payments were often described by research participants as benefits. Challenges included: tensions within households and communities resulting from lack of clarity and agreement on who is eligible for benefits; suspicion regarding motivation for their provision; and confusion caused by differences between studies in types and levels of benefits.ConclusionsResearch staff differed in their views on how benefits should be approached. Echoing elements of international benefit sharing and ancillary care debates, some research staff saw research as based on goodwill and partnership, and aimed to avoid costs to participants and a commercial relationship; while others sought to maximise participant benefits given the relative wealth of the institution and the multiple community needs. An emerging middle position was to strengthen collateral or indirect medical benefits to communities through collaborations with the Ministry of Health to support sustainability.