Use of assent documents and supportive pediatric care practices: results from a national survey in Japan

Japanese research guidelines mandate obtaining written consent from pediatric patients in a manner suitable to their level of decision-making capacity when conducting interventional studies. However, whether child informed assent (IA) is obtained using written IA documents in clinical practice remains unclear. We aimed to determine the extent to which written IA documents are used to obtain IA for medical procedures in Japanese hospitals and to identify measures implemented to respect the preferences of pediatric patients. We conducted a nationwide cross-sectional survey to clarify current practices in this context. In September 2023, we conducted a cross-sectional questionnaire survey among 119 hospitals registered as "core hospitals" by the Japan Pediatrics Society. Of the 119 hospitals invited, 51 (42.9%) responded, and 44 (37.0%) valid responses were included in the analysis. Although 43 hospitals (97.7%) reported possessing informed-consent documents for medical procedures such as contrast-enhanced computed tomography, contrast-enhanced magnetic resonance imaging, blood transfusion, and general anesthesia, only two hospitals (4.5%) reported having explanatory documents specifically for obtaining child IA for any of these procedures. Many hospitals reported implementing measures such as psychological preparation to respect the preferences of pediatric patients, and approximately 60% had established "pediatric patient rights." Few institutions in Japan possess explanatory documents to obtain child IA in clinical pediatric practice. Further discussion is warranted to develop and implement effective measures, including explanatory documents for IA, to better respect children's autonomy and participation in healthcare decisions.