In pediatric trials, which role provides consent for the child?

In pediatric trials, which role provides consent for the child?

• A. The sponsor
• B. The child themselves
• C. The IRB
• D. Legally Authorized Representative (LAR)

Answer: (D)

In pediatric trials, the person who provides consent is the Legally Authorized Representative. Minors generally cannot give legally valid informed consent, so a parent, guardian, or another individual legally empowered by law to consent on behalf of the child reviews the study, understands its risks and benefits, and agrees to enroll the child. The child’s participation is then supported by the parent’s/guardian’s consent, and the child should give assent when able and appropriate. The sponsor handles the study’s execution, not the individual consent for the child, and the IRB reviews and approves the consent process but does not consent on behalf of the child.

In pediatric trials, the person who provides consent is the Legally Authorized Representative. Minors generally cannot give legally valid informed consent, so a parent, guardian, or another individual legally empowered by law to consent on behalf of the child reviews the study, understands its risks and benefits, and agrees to enroll the child. The child’s participation is then supported by the parent’s/guardian’s consent, and the child should give assent when able and appropriate. The sponsor handles the study’s execution, not the individual consent for the child, and the IRB reviews and approves the consent process but does not consent on behalf of the child.