Re-consent is needed if what occurs?

• A. Re-consent only for minors
• B. Re-consent only for changes in investigator
• C. Re-consent is needed if new information impacts willingness to continue, especially regarding emerging safety concerns
• D. Re-consent is never needed

Answer: (C)

Informed consent is an ongoing process, so re-consent is required when new information could affect a participant’s willingness to continue in the trial. That includes emerging safety concerns or any updates that change the risk–benefit assessment or the procedures involved. If new data or risks become available, investigators must share that information with participants and obtain their updated agreement to continue. It isn’t limited to minors, isn’t about changes in the investigator alone, and isn’t never needed. Re-consent ensures participants can make an informed, voluntary decision in light of new information.