Towards a sensitive process of assent in pediatric clinical trials: a qualitative study on the patient perspective

This study explored how adolescents experience the assent process in pediatric clinical trials. It examined their perspectives on the clarity, relevance, and adequacy of assent materials and generated insights to inform the development of more effective tools that support meaningful participation in research decision-making. A qualitative constructivist design was employed with participants from the KIDS Madrid Young People Advisory Group. The sample included 11 adolescents aged 15-19 years, 70% with prior hospital experience and 30% without. Data were collected through two semi-structured focus groups of 80 min each, moderated by trained facilitators. Transcripts were analyzed using inductive content analysis, beginning with open coding to identify themes, followed by clustering and refinement through researcher triangulation. The analysis revealed five themes shaping adolescents' views on assent: communication, adherence, format, quality of life impact, and decision-making. Communication was the most salient and recurrent theme to the study's contribution, with clarity, empathy, and trusted professionals fostering confidence and dialogue. Respectful and informative interactions enhanced adherence, often linked to altruism. Participants criticized lengthy, technical documents and favored youth-friendly formats such as videos or graphics. They also stressed the need for transparency about daily life disruptions and valued being involved in decisions, which reinforced confidence and a sense of partnership in care.

This study shows that treating assent as a meaningful process improves adolescents' engagement and adherence. Clear, empathetic, age-appropriate communication helps them feel respected and empowered, while trust, emotional safety, and autonomy are key to adapting communication to their needs.

• Pediatric patients are often legally unable to provide informed consent; still, obtaining informed assent constitutes an ethical imperative. • Obtaining informed assent may be especially challenging, as complex health-related information must be conveyed in an age-appropriate manner.

• This study sought to gain insight into the process of informed assent in clinical trials by focusing on the perspective of patients. • Potential challenges interfering with the process of informed assent may be overcome by strengthening communication between health practitioners and patients.