|- candidate number||14591|
|- NTR Number||NTR3918|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-mrt-2013|
|- Secondary IDs||113105006 ZonMW|
|- Public Title||Kunnen kinderen (niet) goed beslissen over meedoen aan medicatieonderzoek?|
|- Scientific Title||Development and use of a standardised instrument for assessing children’s competence to consent in drug trials: Are legally established age limits valid?|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Minors, Children, Drug trials, Informed consent|
|- Inclusion criteria||1. Age 6-18 years;|
2. In informed consent procedure of medical research.
|- Exclusion criteria||Not speaking dutch.|
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-jan-2012|
|- planned closingdate||1-jul-2015|
|- Target number of participants||160|
|- Interventions||1. Videotaping of the usual informed consent procedure;|
2. Modified MacCAT-CR semistructured interview;
3. Wechsler Nonverbal IQ subtests.
|- Primary outcome||1. MacCAT-CR scores and binary judgment of children's competence to consent;|
2. Reference standard of children's competence to consent;
3. Validity and reliability of MacCAT-CR.
|- Secondary outcome||Correlation of children's competence to consent to age, IQ, parental judgment of children's competence, ethnicity, trial- and illnessexperience.|
|- Timepoints||After the ususal informed consent procedure, within short notice the interview will be performed.|
|- Trial web site||www.maccat-cr.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| I.M. Hein|
|- CONTACT for SCIENTIFIC QUERIES|| I.M. Hein|
|- Sponsor/Initiator ||Academic Medical Center (AMC, Amsterdam), De Bascule, Academic Center for Child and Adolescent Psychiatry (Amsterdam)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||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?
|- Main changes (audit trail)|
|- RECORD||25-mrt-2013 - 6-apr-2013|