Kunnen kinderen (niet) goed beslissen over meedoen aan medicatieonderzoek?
Recruiting
- Conditions
- children's competence to consent, informed consent in minors, children's consent in drug trials.wilsbekwaamheid bij kinderen, informed consent bij minderjarigen, informed consent bij kinderen in medicatieonderzoek.
- Registration Number
- NL-OMON27426
- Lead Sponsor
- Academic Medical Center Amsterdam and de Bascule Amsterdam
- Brief Summary
http://www.biomedcentral.com/1471-2431/12/156
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 160
Inclusion Criteria
1. Age 6-18 years;
2. In informed consent procedure of medical research.
Exclusion Criteria
Not speaking dutch.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. MacCAT-CR scores and binary judgment of children's competence to consent;<br /><br>2. Reference standard of children's competence to consent;<br /><br>3. Validity and reliability of MacCAT-CR.
- Secondary Outcome Measures
Name Time Method Correlation of children's competence to consent to age, IQ, parental judgment of children's competence, ethnicity, trial- and illnessexperience.