Recruiting pupils for a school-based eye study in Nigeria: Trust and informed consent concerns

Abstract

School-based research presents ethical challenges, especially with respect to informed consent. The manner in which pupils and their parents respond to an invitation to participate in research is likely to depend on several factors, including the level of trust between them and the researchers. This paper describes our recruitment and consent process for a school-based eye study in Nigeria. In the course of our study, a particular governmental incident helped to fuel public mistrust in governmental programs and posed a potential threat to our recruitment efforts. The recruitment and consent process included series of advocacy visits to stakeholders in the education sector, highly interactive briefing and health talk sessions in schools, use of telephone services as a medium for information dissemination, age-appropriate study information, parental consent, and pupil assent. Of the 6598 pupils provided with study information, 5723 returned parental consent forms. There were 69 cases of pupils who dissented despite having parental consent. The two leading concerns for the parents/guardians were the rumors regarding a military/governmental-sponsored health campaign and the side-effects of the dilating eye-drops. Nevertheless, our high level of recruitment suggests our recruitment and consent process was successful in assuaging fears for the vast majority of pupils and their parents.