In minors, what is the role of assent in addition to parental consent?

Boost your GCP E6 (R3) exam readiness. Improve your understanding with engaging, insightful questions. Test yourself with hints and detailed explanations. Prepare effectively!

Multiple Choice

In minors, what is the role of assent in addition to parental consent?

Assent is the minor’s affirmative agreement to participate, expressed in terms appropriate to their level of understanding. It is not the same as parental consent and does not replace it. In pediatric research, you obtain parental/guardian consent in addition to seeking the child’s assent when the child is capable of understanding the study. The assent process should follow local regulatory requirements and be reviewed by the ethics/IRB body, with documentation of the child’s willingness or dissent as appropriate. If a child cannot understand or assent, parental consent may be sufficient under the rules, but whenever possible, the child’s assent should still be sought and respected.

Assent is the minor’s affirmative agreement to participate, expressed in terms appropriate to their level of understanding. It is not the same as parental consent and does not replace it. In pediatric research, you obtain parental/guardian consent in addition to seeking the child’s assent when the child is capable of understanding the study. The assent process should follow local regulatory requirements and be reviewed by the ethics/IRB body, with documentation of the child’s willingness or dissent as appropriate. If a child cannot understand or assent, parental consent may be sufficient under the rules, but whenever possible, the child’s assent should still be sought and respected.

More practice questions