If a new risk or new information affects a participant's participation, what action is required?

• A. No action is needed
• B. Re-consent is required only for new protocols
• C. Re-consent or update consent as appropriate
• D. The study must be terminated

Answer: (C)

Informed consent is an ongoing process. When new risk information or a new issue affects a participant’s willingness or ability to continue, you must ensure they understand and agree to remain in the study under the updated information. The required action is to re-consent or update consent as appropriate. This means providing clear, understandable details about the new risks, any changes to procedures, and available alternatives, then obtaining the participant’s fresh agreement to continue. The consent document might be updated with an addendum or a revised form, and the participant signs to acknowledge understanding and consent. This approach keeps participation voluntary and ethically sound. It’s not acceptable to do nothing, nor is termination mandated solely because new information emerges, and the need to re-consent isn’t limited to cases involving new protocols.