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Open Access Study protocol

Assessing children’s competence to consent in research by a standardized tool: a validity study

Irma M Hein1*, Pieter W Troost1, Robert Lindeboom2, Martine C de Vries3, C Michel Zwaan4 and Ramón J L Lindauer1

Author Affiliations

1 Department of Child and Adolescent Psychiatry and de Bascule, Academic Medical Center Amsterdam, Meibergdreef 5, Amsterdam, 1105, AZ, The Netherlands

2 Division of Clinical Methods and Public Health, Master Evidence Based Practice, Academic Medical Center Amsterdam, Meibergdreef 9, Amsterdam, 1105, AZ, The Netherlands

3 Department of Medical Ethics and Health Law, Leiden University Medical Center, PO Box 9600, Leiden, 2300, RC, The Netherlands

4 Department of Pediatric Oncology and Hematology, Erasmus Medical Center Rotterdam, Dr Molewaterplein 60, Rotterdam, 3015, GJ, The Netherlands

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BMC Pediatrics 2012, 12:156  doi:10.1186/1471-2431-12-156

Published: 25 September 2012

Abstract

Background

Currently 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/design

In 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.

Discussion

A 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.

Keywords:
Competence; Consent; Assessment; Tool; Drug trial; Informed consent; Decision making; Research; Child; Adolescent