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
Highlights
There are a number of practical and ethical issues raised in school-based health research, those related to obtaining consent from parents and assent from children
Experiences, and challenges This section has been divided into three main themes, each of which could be considered a stage in a wider community engagement and consenting process: (1) community entry and randomization; (2) sensitizing and consenting parents and teachers; and (3) informing and assenting children
Community entry and randomization To conduct the research in Kenyan schools, and to facilitate the uptake of findings, the trial staff engaged with four groups of health and education sector stakeholders at national, provincial, district, and local level
Summary
There are a number of practical and ethical issues raised in school-based health research, those related to obtaining consent from parents and assent from children. 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. More research is being conducted to identify additional interventions that can address the health problems of school-age children [2]. There are a number of practical and ethical issues raised in conducting such research in school settings, including those related to consent/assent and community engagement. School children aged less than 18 years are considered by many to lack the cognitive maturity and moral development to make individual decisions about research participation [3]. Children’s assent must be secured before involving them in research [4]
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