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

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

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.