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Standardizing Reporting of Pediatric Assent in Clinical Trials
Shizuko Takahashi1,2,3, Jerry Menikoff1
1Centre for Biomedical Ethics (CBmE), National University of Singapore, Yong Loo Lin School of Medicine, Singapore.
Pediatrics
|January 21, 2026
Summary
Pediatric assent documentation in clinical research is inconsistent and sparse, often embedded within parental consent. Standardized reporting is needed to ensure children
Area of Science:
- Pediatric Ethics
- Clinical Trial Methodology
- Research Integrity
Background:
- Ethical consensus emphasizes pediatric assent, yet its documentation in clinical research is inconsistent.
- Current practices show underreporting of how assent is obtained, waived, or overridden in pediatric trials.
- Lack of transparency in assent processes compromises ethical accountability and evaluation of children's involvement.
Purpose of the Study:
- To examine the systemic underreporting of pediatric assent practices in clinical research.
- To analyze how assent is documented within pediatric oncology trials.
- To propose recommendations for improved assent documentation standards.
Main Methods:
- Review of pediatric oncology trial registries.
- Analysis of informed consent forms.
- Examination of published research studies on pediatric assent.
Main Results:
- Pediatric assent is frequently embedded within parental consent, lacking detailed documentation.
- Inconsistent interpretation and application of assent processes across studies were observed.
- Underreporting prevents evaluation of children's informed involvement and opportunities to dissent.
Conclusions:
- Minimal reporting standards are crucial for evaluating ethical assent practices in pediatric research.
- Trial registries and journals should adopt requirements for documenting assent, disagreement, and resolution.
- Standardized, developmentally appropriate documentation of assent is essential for respecting children's voices and ensuring ethical research and clinical care.
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