Abstract
BackgroundCurrently over 50% of drugs prescribed to children have not been evaluated properly for use in their age group. One key reason why children have been excluded from clinical trials is that they are not considered able to exercise meaningful autonomy over the decision to participate. Dutch law states that competence to consent can be presumed present at the age of 12 and above; however, in pediatric practice children’s competence is not that clearly presented and the transition from assent to active consent is gradual. A gold standard for competence assessment in children does not exist. In this article we describe a study protocol on the development of a standardized tool for assessing competence to consent in research in children and adolescents.Methods/designIn this study we modified the MacCAT-CR, the best evaluated competence assessment tool for adults, for use in children and adolescents. We will administer the tool prospectively to a cohort of pediatric patients from 6 to18 years during the selection stages of ongoing clinical trials. The outcomes of the MacCAT-CR interviews will be compared to a reference standard, established by the judgments of clinical investigators, and an expert panel consisting of child psychiatrists, child psychologists and medical ethicists. The reliability, criterion-related validity and reproducibility of the tool will be determined. As MacCAT-CR is a multi-item scale consisting of 13 items, power was justified at 130–190 subjects, providing a minimum of 10–15 observations per item. MacCAT-CR outcomes will be correlated with age, life experience, IQ, ethnicity, socio-economic status and competence judgment of the parent(s). It is anticipated that 160 participants will be recruited over 2 years to complete enrollment.DiscussionA validity study on an assessment tool of competence to consent is strongly needed in research practice, particularly in the child and adolescent population. In this study we will establish a reference standard of children’s competence to consent, combined with validation of an assessment instrument. Results can facilitate responsible involvement of children in clinical trials by further development of guidelines, health-care policies and legal policies.
Highlights
Over 50% of drugs prescribed to children have not been evaluated properly for use in their age group
A validity study on an assessment tool of competence to consent is strongly needed in research practice, in the child and adolescent population
Non-competent children would no longer have to be burdened by the full informed-consent procedure, while competent children would be more actively engaged in that procedure, with extra weight given to their opinions
Summary
Over 50% of drugs prescribed to children have not been evaluated properly for use in their age group. Non-competent children would no longer have to be burdened by the full informed-consent procedure, while competent children would be more actively engaged in that procedure, with extra weight given to their opinions This would facilitate the implementation of clinical trials in children and adolescents and still protect the vulnerable subjects. According to the Dutch Medical Treatment Contracts Act (WGBO), which applies to treatment situations, parents decide for their children younger than 12 years of age, who are considered by definition incompetent to act for themselves. For these children, no actual assessment of competence is necessary. The statutory age limits differ for clinical research: the lower age limit varies form 7 to 15, the upper age limit is set at 17 or 18 years [5]
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