Child's assent in research: age threshold or personalisation?

Assent is an important ethical and legal requirement of paediatric research. Unfortunately, there are significant differences between the guidelines on the details of assent.

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.

A recommended age threshold is likely to serve the interests of children better than ambiguous and flexible criteria for personalised age determination.