Public and patient involvement in developing a survey on re-consent for pediatric genomic data sharing in Japan: a...

In Japan, adolescents who entered genomic research under proxy consent are asked to re-consent at age 16 for newly collected data, while previously collected data remain usable without consent. Public perspectives on re-consent and data sharing are not well understood. To prepare a survey for adolescents, we used public and patient involvement (PPI) to refine the questionnaire and information sheet.

Four stages of PPI were conducted: a kickoff meeting, two rounds of web-based feedback, and a final discussion. Five PPI members (aged 20-60 s, diverse backgrounds) provided iterative feedback on survey design, wording, and framing. All revisions were documented using GRIPP2-Long Form.

PPI members expressed diverse views on re-consent and acceptable secondary data use, supporting the relevance of the survey design. Feedback resulted in major revisions, including clearer terminology, unified wording, improved explanations of parent-child context, existing versus newly collected data, age categorization, and Japan's opt-out procedures. Of 36 comments in the first round, 30 (83%) were incorporated; of 23 comments in the second round, 20 (87%) were incorporated.

PPI enhanced the clarity, cultural relevance, and acceptability of materials for a survey on re-consent in pediatric genomic data sharing. As one of the first systematic PPI reports from Japan, this work demonstrates how systematic involvement strengthens ethically sensitive research and provides a transparent foundation for forthcoming surveys.