Child’s assent in research: Age threshold or personalisation?

BACKGROUND: Assent is an important ethical and legal requirement of paediatric research. Unfortunately, there are significant differences between the guidelines on the details of assent. DISCUSSION: What often remains unclear is the scope of the assent, the procedure for acquiring it, and the way in which children’s capacity to assent is determined. There is a general growing tendency that suggests that the process of assent should be personalised, that is, tailored to a particular child. This article supports the idea of personalisation. However, we also propose placing limits on personalisation by introducing a suggested requirement of assent starting at a school-age threshold. In some situations RECs/IRBs and researchers could reduce the suggested threshold. SUMMARY: A recommended age threshold is likely to serve the interests of children better than ambiguous and flexible criteria for personalised age determination.