Development of a Locally Designed Questionnaire to Determine the Capability of the Pediatric Population to Actively Participate in the Assent Process Based on the Relevant Domains and Factors in the Philippines

Background: The Philippines National Ethical Guidelines currently tasks researchers to assess a child’s competence prior to assent using their standard assent template but the assessment of the child’s competence is inconsistent since there’s no local process that seeks to assess children’s capability prior to assent. Objective: To bridge this gap, this research aims to determine the factors and domains that affect a child’s capacity to assent and develop a locally designed questionnaire. Method: The study has 2 stages: Stage 1 identified the factors and domains affecting a child’s capability to assent through a review of related literature, key informant interviews with experts, and focus group discussions with pediatric researchers. A qualitative analysis of emergent themes utilizing NVivo software was conducted. Stage 2 focused on the drafting of the questionnaire. Results: Nine factors and six domains were identified. The former are age, cognitive development, language, education, psychological and emotional status, culture, comorbidities, willingness to participate and socioeconomic status; while the latter are understanding, reasoning, interest, appreciation, voluntarism, and ability to read and write. These were incorporated into the questionnaire in assessing a child’s capacity to assent. Conclusion: The capacity of a child’s competence to assent in research involves complex processes, which are affected by different factors and domains.