If new information becomes available that may affect a subject's willingness to continue participation, who should be informed?

• A. The subject or the subject's legally acceptable representative.
• B. The sponsor only.
• C. The investigator only.
• D. No one.

Answer: (A)

When new information arises that could influence a participant’s decision to continue, you must inform the person who is participating in the study. The subject or, if they cannot consent themselves, the subject’s legally acceptable representative, is the one who should be informed so they can decide whether to stay in the trial. The investigator is responsible for communicating that information clearly and, if needed, obtaining updated consent. Informing the sponsor alone or not informing anyone would not uphold the participant’s right to make an informed decision about continued participation.