Which term refers to an individual or body authorized to consent on behalf of a prospective subject?

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

Answer: (A)

When a prospective subject cannot give consent themselves, someone else must be authorized to consent on their behalf. This person or body is described as a legally authorized representative (often referred to in practice as a legally acceptable representative). The key idea is that this surrogate has legal authority to make decisions about participation in the trial for the subject, protecting the subject’s rights and welfare. The surrogate’s authority is defined by law, regulation, or the trial protocol, and their role is specifically to consent to participation, not to take on other trial responsibilities. The investigator cannot obtain consent from an unaffiliated person on the subject’s behalf, and terms like monitoring or interim study reports do not relate to surrogate consent.