In a non-therapeutic trial, who normally must give consent and sign the written informed consent, unless an exception is justified?

• A. The subject's legally acceptable representative
• B. The sponsor
• C. The subject personally gives consent and signs the written informed consent
• D. The IRB approves on behalf of the subject

Answer: (C)

The door to participation is the subject’s own decision. In a non-therapeutic study, a capable adult must understand the information, freely agree, and personally sign the written informed consent to show they are voluntarily entering the research. This emphasizes respect for the individual's autonomy and ensures the participant controls whether they take part.

A legally acceptable representative would only sign if the person cannot consent and the study and local law permit surrogate consent—it's not the normal situation for a capable adult. The sponsor does not sign on behalf of the participant, and the IRB reviews and approves the consent process and documents but does not substitute for the subject’s signature.