What should happen if new information becomes available that may affect willingness to continue in a trial?

• A. The participant or their representative should be informed in a timely manner, and the communication should be documented
• B. The communication should be kept confidential and not documented
• C. Only the sponsor should be informed
• D. Only at the end

Answer: (A)

When new information could influence a participant’s decision to stay in the trial, you must promptly inform the participant or their legally authorized representative and document the communication. This maintains ongoing informed consent and respects the participant’s autonomy by giving them the opportunity to reassess their participation in light of the new information. Examples include new safety risks, changes to the risk-benefit balance, or protocol amendments that could affect their willingness to continue. Documentation is essential to show that the information was provided and acknowledged. Keeping information confidential, not documenting it, or waiting to inform only the sponsor or only at the end would fail to protect the participant’s rights and safety.