Development of children's assent documents using a child-centred approach.

Area of Science:

• Pediatric healthcare research
• Child psychology
• Bioethics

Background:

• Increasing emphasis on child-centered healthcare necessitates obtaining informed assent from children.
• Traditional research information and assent forms may not be easily understood by pediatric populations.
• Developing age-appropriate communication tools is crucial for ethical child participation in research.

Purpose of the Study:

• To describe the process of involving primary school children in developing research information and assent forms.
• To enhance the understandability and readability of documents for pediatric research participants.
• To explore the concepts of language, understandability, and readability in the context of informed assent.

Main Methods:

• Collaborative development of research information and assent forms with primary school children (aged 6-12).
• Children worked in small groups to determine content for the documents.
• Participant feedback and language analysis were used to refine the documents.

Main Results:

• Involving children in the development process led to more understandable information and assent forms.
• The resulting documents were better tailored to the cognitive abilities and language comprehension of child participants.
• Key considerations for researchers include 'language', 'understandability', and 'readability' for effective informed assent.

Conclusions:

• Directly involving children in creating research materials significantly improves their understandability.
• Researchers must prioritize child-friendly language and design to ensure truly informed assent.
• This participatory approach supports ethical engagement and enhances the quality of pediatric research.