Which entity is authorized under applicable law to consent on behalf of a prospective subject to participate in the trial?

Which entity is authorized under applicable law to consent on behalf of a prospective subject to participate in the trial?

• A. Legally Acceptable Representative
• B. Investigator
• C. Monitoring
• D. Interim Clinical Trial/Study Report

Answer: (A)

Consent for participation can be given by the person who will participate or by someone legally authorized to decide for them. A legally acceptable representative is someone empowered by law to consent on behalf of the prospective subject when the subject cannot consent themselves—such as a parent or guardian for a minor, or a legally authorized representative for an incapacitated adult. The investigator’s role is to obtain consent from the subject or the legally authorized representative, not to substitute their own decision. Monitoring and interim study reports are not entities that give consent; monitoring is oversight, and a study report is a document.

Consent for participation can be given by the person who will participate or by someone legally authorized to decide for them. A legally acceptable representative is someone empowered by law to consent on behalf of the prospective subject when the subject cannot consent themselves—such as a parent or guardian for a minor, or a legally authorized representative for an incapacitated adult. The investigator’s role is to obtain consent from the subject or the legally authorized representative, not to substitute their own decision. Monitoring and interim study reports are not entities that give consent; monitoring is oversight, and a study report is a document.