Who provides consent for minors?

Who provides consent for minors?

• A. The principal investigator
• B. The IRB
• C. Legally Authorized Representative (LAR)
• D. The sponsor

Answer: (C)

Consent for minors is given by a Legally Authorized Representative, typically a parent or guardian. Since children cannot legally provide informed consent, someone with the legal authority to make decisions for the child must give permission for participation in the study. This protects the minor’s welfare and ensures the consent is legally valid. The parent or guardian is the common example of the LAR in pediatric trials, while the minor may give assent when capable. The principal investigator facilitates obtaining the LAR’s consent, the IRB reviews and approves the consent process, and the sponsor oversees the study, but none of them substitutes for the LAR’s consent.

Consent for minors is given by a Legally Authorized Representative, typically a parent or guardian. Since children cannot legally provide informed consent, someone with the legal authority to make decisions for the child must give permission for participation in the study. This protects the minor’s welfare and ensures the consent is legally valid. The parent or guardian is the common example of the LAR in pediatric trials, while the minor may give assent when capable. The principal investigator facilitates obtaining the LAR’s consent, the IRB reviews and approves the consent process, and the sponsor oversees the study, but none of them substitutes for the LAR’s consent.