Children’s competence to consent to medical treatment or research

In this study, we have explored the issue of children’s abilities to meaningfully decide on complex and important medical options, of which, until recently, little was known except that it often proved difficult to assess a child’s competence in some clinical settings. Nor was there empirical evidence on children’s competence to consent to treatment or clinical research to underpin these problematic areas. Yet problems did arise, when, for instance, pediatric patients did not agree with a recommended treatment. Or, when, in a research context, it remained unclear how to do justice to children’s vulnerable population status while attempting to optimize their research participation.
With our project we aimed at developing a standardized tool for assessing children’s competence to consent and to offer empirical evidence to underpin age limits for alleged competence in children in order to optimize policies regarding children’s decision-making in clinical situations.
The present studies showed that children’s competence to consent to clinical research can be assessed validly and reliably using the MacCAT-CR, and feasibility of the MacCAT-T for assessing children’s competence to consent to treatment was confirmed. Using the MacCAT-CR, age limits for children to be deemed competent to decide on research participation could be estimated: children of 11.2 years and above generally appeared to be competent, whereas children of 9.6 years and younger were generally not competent. The key determining factor, out of all the factors that were considered to influence children’s competency, was age. Considering the implications of these empirical findings for law, ethics and clinical practice, we recommended that 12 years would be a just age-limit for asking children’s consent to clinical research.