In trials where enrollment can occur only with the consent of the subject's legally acceptable representative, if the subject is capable, what should occur regarding consent?

• A. The subject should sign and personally date the written informed consent.
• B. The legally acceptable representative's consent should be the sole basis for enrollment.
• C. The subject's assent is sufficient for enrollment.
• D. The investigator may proceed without any consent.

Answer: (A)

Respect for the subject’s autonomy means that when a person is capable of giving consent, they must provide their own informed consent. Even in trials where enrollment can occur only with the consent of a legally acceptable representative, if the subject is capable, the subject should sign and personally date the written informed consent. The legally acceptable representative cannot substitute their consent for the capable subject’s consent in this situation. Assent is not the same as consent for an adult, and proceeding without any consent would violate GCP and ethical principles. This approach protects the subject’s rights and maintains proper informed consent documentation.