Kunnen kinderen (niet) goed beslissen over meedoen aan medicatieonderzoek?

Currently over 50% of drugs prescribed to children have not been studied in their age group. Prescribers often have no
alternative but to choose off-label or unauthorised products.
One key reason why children have historically been excluded from drug trials is that they are considered immature and not
really capable of understanding research information. This conflicts with evidence that children as young as 9 years of age are
capable of understanding the issues involved.
If, however, we knew which children are capable of making well considered decisions about drug trial participation, it would be
possible to involve children in a conforming way. More research on drugs in children would help all diseased children
worldwide. An objective assessment of children’s competence to consent is, however, currently not possible.

We propose to develop an instrument to assess children’s competence to consent to research.
In this study we address the following research questions:

1) Can children’s competence to consent be assessed in a reliable and valid way by means of a tool?

2) To what extent do age, IQ and contextual factors correlate with competence to consent?

Once an objective test of competence becomes available for research practice, non-competent children will no longer have to go through the full informed consent procedure. Competent children will be more actively engaged in that procedure, with extra weight given to their opinions. As this would do justice to the ethical principle of children as moral agents, it would have important intrinsic value.

After the ususal informed consent procedure, within short notice the interview will be performed.

1. Videotaping of the usual informed consent procedure;

2. Modified MacCAT-CR semistructured interview;

3. Wechsler Nonverbal IQ subtests.