When is re-consent required?

• A. Immediately after consent
• B. New risks, new information, or protocol changes affecting participation
• C. Only at study completion
• D. When the subject moves to a new site

Answer: (B)

Re-consent is about keeping a participant’s agreement to join the study valid as things change. It’s required whenever new risks, new information about risks, or changes to the study protocol would affect a participant’s willingness to continue. If the trial discovers a previously unknown risk, or a procedure is modified or added in a way that changes the burden or potential harms, the consent form must be updated and the participant re-informed and asked to re-consent. The updated consent, approved by the IRB, gives the participant a fresh choice to continue or withdraw. Simply finishing the study or moving to a different site does not by itself necessitate re-consent unless those changes come with new information or altered risks or procedures that affect participation.