Establishing a global regulatory floor for children’s decisions about participation in clinical research

Establishing a global regulatory floor for children’s decisions about participation in clinical research
Special Article
Steven Joffe, Albert J. Allen, Jonathan M. Davis, Elisa Koppelman, Susan Z. Kornetsky, Grace Marie V. Ku, Victoria A. Miller, Jennifer Preston, Lesha D. Shah, Barbara E. Bierer
Pediatric Research, 28 January 2023
Abstract
Background
Enrolling children in clinical trials typically requires parental or guardian permission and, when appropriate, child assent. Aligning requirements across jurisdictions would facilitate multisite pediatric trials. Guidance from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is the best candidate for a global standard but would benefit from additional specification.
Methods
Ethical analysis of ICH guidance for permission and assent for pediatric trials, with recommendations for clarification.
Results
ICH guidance regarding permission and assent would be enhanced by additional detail in the following areas: (1) what information should be provided to parents, guardians, and children considering a trial, and how that information should be provided; (2) the definition of “assent,” the criteria for when assent should be required, and the need to include children in discussions even when assent is not mandated; (3) criteria for requiring children’s signatures indicating agreement; (4) greater specificity regarding children’s right to decline or withdraw; and (5) clarification of when children’s wish to decline or withdraw from participation may be overridden and of what the overriding process should entail.
Conclusion
ICH guidance provides a global standard for decision-making regarding children’s participation in trials. Several clarifications would facilitate the conduct of multinational pediatric research.