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

- candidate number14591
- NTR NumberNTR3918
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-mrt-2013
- Secondary IDs113105006 ZonMW
- Public TitleKunnen kinderen (niet) goed beslissen over meedoen aan medicatieonderzoek?
- Scientific TitleDevelopment and use of a standardised instrument for assessing children’s competence to consent in drug trials: Are legally established age limits valid?
- hypothesisOnce 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) studiedMinors, Children, Drug trials, Informed consent
- Inclusion criteria1. Age 6-18 years;
2. In informed consent procedure of medical research.
- Exclusion criteriaNot speaking dutch.
- mec approval receivedno
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2012
- planned closingdate1-jul-2015
- Target number of participants160
- Interventions1. Videotaping of the usual informed consent procedure;
2. Modified MacCAT-CR semistructured interview;
3. Wechsler Nonverbal IQ subtests.
- Primary outcome1. 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 outcomeCorrelation of children's competence to consent to age, IQ, parental judgment of children's competence, ethnicity, trial- and illnessexperience.
- TimepointsAfter the ususal informed consent procedure, within short notice the interview will be performed.
- Trial web
- statusopen: patient inclusion
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam, De Bascule, Academic Center for Child and Adolescent Psychiatry (Amsterdam)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryCurrently 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)
- RECORD25-mrt-2013 - 6-apr-2013

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