Challenges for consent and community engagement in the conduct of cluster randomized trial among school children in low income settings: experiences from Kenya

Abstract

BackgroundThere are a number of practical and ethical issues raised in school-based health research, particularly those related to obtaining consent from parents and assent from children. One approach to developing, strengthening, and supporting appropriate consent and assent processes is through community engagement. To date, much of the literature on community engagement in biomedical research has concentrated on community- or hospital-based research, with little documentation, if any, of community engagement in school-based health research. In this paper we discuss our experiences of consent, assent and community engagement in implementing a large school-based cluster randomized trial in rural Kenya.MethodsData collected as part of a qualitative study investigating the acceptability of the main trial, focus group discussions with field staff, observations of practice and authors’ experiences are used to: 1) highlight the challenges faced in obtaining assent/consent; and 2) strategies taken to try to both protect participant rights (including to refuse and to withdraw) and ensure the success of the trial.ResultsEarly meetings with national, district and local level stakeholders were important in establishing their co-operation and support for the project. Despite this support, both practical and ethical challenges were encountered during consenting and assenting procedures. Our strategy for addressing these challenges focused on improving communication and understanding of the trial, and maintaining dialogue with all the relevant stakeholders throughout the study period.ConclusionsA range of stakeholders within and beyond schools play a key role in school based health trials. Community entry and information dissemination strategies need careful planning from the outset, and with on-going consultation and feedback mechanisms established in order to identify and address concerns as they arise. We believe our experiences, and the ethical and practical issues and dilemmas encountered, will be of interest for others planning to conduct school-based research in Africa.Trial registrationNational Institute of Health NCT00878007

Ethical responsibilities toward indirect and collateral participants in pragmatic clinical trials

“…Engagement and communication may increase understanding of the research process and build trust, and may also support the ethical conduct of research and enhance acceptance of, participation in, and retention in research trials and recruitment for future trials. 26 If culture change occurs such that participants are indeed more active participants in the process, we hope all participants, direct, indirect, or collateral, will be empowered and informed. Regardless of distinctions among direct, indirect, and collateral participants, there should be no distinction in our imperative to build trust and consider protections for all participants.…”

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

“…22 Managing Different Expectations: The transfer of material benefits such as health care resources was expected by the community and was believed to encourage participation, but this approach could undermine intrinsic motivation. 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.…”

“…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. So it is better to get them involved to be able to source some information from them, to be able to get their view about the project to move to the next stage, because they always have important contributions to make to the project, to improve on what you have."…”

“…31,40 Retaining Community Intermediaries' Involvement: Retention of community workers was deemed critical for a trial to be successful, but potential barriers included dissatisfaction with remuneration, limited scope of responsibilities, heavy workload, work-related travel, familial opposition, and negative attitudes of parents toward the workers. 12,13 Community workers were motivated to participate because of recognition and appreciation, altruism, humanitarian, and religious reasons, but they recommended appropriate compensation and incentives to improve retention.…”

“…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.…”