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Assessing children's competence to consent in research by a standardized tool: a validity study
Irma M Hein1, Pieter W Troost, Robert Lindeboom
1Department of Child and Adolescent Psychiatry and de Bascule, Academic Medical Center Amsterdam, Meibergdreef 5, Amsterdam, 1105, AZ, The Netherlands. i.hein@debascule.com
BMC Pediatrics
|September 27, 2012
Summary
Developing a standardized tool is crucial for assessing children's competence to consent in research. This study aims to validate a modified adult tool for pediatric use, ensuring ethical and responsible clinical trial participation.
Area of Science:
- Pediatric Research Ethics
- Clinical Trial Methodology
- Child and Adolescent Psychology
Background:
- Over 50% of pediatric drugs lack proper evaluation due to children's exclusion from trials.
- Children's autonomy in research participation is often questioned, with unclear consent processes.
- A standardized method for assessing competence to consent in minors is currently unavailable.
Purpose of the Study:
- To develop and validate a standardized tool for assessing competence to consent in children and adolescents participating in clinical trials.
- To establish a reliable and reproducible assessment instrument for pediatric research.
- To facilitate the ethical and responsible inclusion of minors in clinical research.
Main Methods:
- Modification of the MacCAT-CR (MacArthur Competence Assessment Tool for Clinical Research) for pediatric use.
- Prospective administration of the modified tool to pediatric patients aged 6-18 during clinical trial recruitment.
- Comparison of tool outcomes against a reference standard established by clinical investigators and an expert panel.
- Assessment of reliability, criterion-related validity, and reproducibility, with correlation to demographic and experiential factors.
Main Results:
- The study protocol outlines the systematic modification and validation of the MacCAT-CR for pediatric populations.
- A target enrollment of 160 participants over two years is planned to ensure adequate statistical power.
- The study will provide data on the reliability and validity of the modified assessment tool.
Conclusions:
- A validated tool for assessing competence to consent in children is essential for ethical research practices.
- This study will establish a reference standard and validate an assessment instrument for pediatric competence to consent.
- Findings will inform guidelines and policies, promoting responsible child involvement in clinical trials.
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