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

被引:34
|
作者
Hein, Irma M. [1 ]
Troost, Pieter W. [1 ]
Lindeboom, Robert [2 ]
de Vries, Martine C. [3 ]
Zwaan, C. Michel [4 ]
Lindauer, Ramon J. L. [1 ]
机构
[1] Univ Amsterdam, Acad Med Ctr, Dept Child & Adolescent Psychiat, NL-1105 AZ Amsterdam, Netherlands
[2] Univ Amsterdam, Acad Med Ctr, Div Clin Methods & Publ Hlth, NL-1105 AZ Amsterdam, Netherlands
[3] Leiden Univ, Med Ctr, Dept Med Eth & Hlth Law, NL-2300 RC Leiden, Netherlands
[4] Erasmus MC, Dept Pediat Oncol & Hematol, NL-3015 GJ Rotterdam, Netherlands
来源
BMC PEDIATRICS | 2012年 / 12卷
关键词
Competence; Consent; Assessment; Tool; Drug trial; Informed consent; Decision making; Research; Child; Adolescent; DECISION-MAKING; CLINICAL-RESEARCH; MENTAL-CAPACITY; ADOLESCENTS; JUDGMENTS; ATTITUDES; CANCER;
D O I
10.1186/1471-2431-12-156
中图分类号
R72 [儿科学];
学科分类号
100202 ;
摘要
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 to 18 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.
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页数:8
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