Working with Community Health Workers as ‘Volunteers’ in a Vaccine Trial: Practical and Ethical Experiences and Implications

Abstract

Community engagement is increasingly emphasized in biomedical research, as a right in itself, and to strengthen ethical practice. We draw on interviews and observations to consider the practical and ethical implications of involving Community Health Workers (CHWs) as part of a community engagement strategy for a vaccine trial on the Kenyan Coast. CHWs were initially engaged as an important network to be informed about the trial. However over time, and in response to community advice, they became involved in trial information sharing and identifying potential participants; thereby taking on roles that overlapped with those of employed fieldworkers (FWs). While CHWs involvement was generally perceived as positive and appreciated, there were challenges in their relations with FWs and other community members, partly related to levels and forms of remuneration. Specifically, payment of CHWs was not as high as for FWs and was based on ‘performance’. This extrinsic motivation had the potential to crowd out CHWs intrinsic motivation to perform their pre-existing community roles. CHWs remuneration potentially also contributed to CHWs distorting trial information to encourage community members to participate; and to researchers encouraging CHWs to utilize their social connections and status to increase the numbers of people who attended information giving sessions. Individual consent processes were protected in this trial through final information sharing and consent being conducted by trained clinical staff who were not embedded in study communities. However, our experiences suggest that roles and remuneration of all front line staff and volunteers involved in trials need careful consideration from the outset, and monitoring and discussion over time.

Cost–effectiveness of community-based practitioner programmes in Ethiopia, Indonesia and Kenya

“… 36 For example, in Kenya, if reliable data about these factors and their implications had been available and included, using volunteers may not have been as cost-effective as our model suggests. Reimbursement and volunteering raise complex ethical and economic questions, 37 which have led to a revision in Kenya’s community health strategy. 38 …”

Stakeholder Views of Clinical Trials in Low- and Middle-Income Countries: A Systematic Review

“…16,19,20,22 They believed that culturally appropriate strategies were necessary to educate the community about new interventions and encourage active participation in research. Community leaders in Ghana suggested using traditional community gatherings, which included cultural activities such as drumming and dancing.…”

“…20,31 Endorsement by "chiefs" and understanding their role as "gatekeepers and mediators" was considered necessary to "allay suspicion, to nurture trust, and to establish the researchers' credibility." 16 Involving trusted "grassroot" 19 intermediaries such as community workers was deemed vital in "opening the way" 21 for researchers. Employing fieldworkers with knowledge of local customs was supported to facilitate recruitment of participants.…”

“…28,31 Tensions arose because volunteer community workers were dissatisfied with their poor incentives compared with the payment of the fieldworkers employed on the trial. 19,21 The expectations of community workers to enroll participants for payment differed from the expectations of researchers, who believed that community workers should not be directly involved in consenting participants to avoid conflict of interest. 24,31 Some recommended having mediators (eg, community Centrality of community engagement Assisting in mobilizing community "If you don't get them involved, you may in the end implement something that will be strange or something that they will not embrace at all.…”

Enhancing quality and integrity in biomedical research in Africa: an international call for greater focus, investment and standardisation in capacity strengthening for frontline staff

“…Fieldworkers typically undertake a range of frontline activities to support studies, including seeking informed consent for study participation, collecting different types of data and undertaking non-invasive sample-taking or measurement procedures. All fieldworkers in these centres are routinely trained on study specific techniques, but managers universally recognised the practical and ethical challenges and dilemmas presented by the ‘expanded roles’ of fieldworkers; building relationships, responding to community members’ expectations and needs, and supporting both community understanding of research and recruitment into studies [ 3 , 5 , 9 , 10 ]. There was recognition that these are complex roles that include balancing of institutional roles and guidelines against the community expectations and fieldworkers’ personal interests.…”