Which statement correctly describes the requirement for revised consent materials before use?

• A. They must be approved by sponsor
• B. IRB/IEC approval or favorable opinion in advance of use
• C. They can be used without approval if the study changes
• D. They must be approved after use

Answer: (B)

Any revised consent materials must receive IRB/IEC approval or a favorable opinion before they are used. This requirement ensures that new information, potential risks, or changes in the study are reviewed for clarity, accuracy, and ethical implications, so participants can make an informed decision based on up‑to‑date and properly vetted information. The sponsor cannot authorize the use of revised consent forms by itself; the IRB/IEC is the body responsible for protecting participants’ rights and welfare. Using revised consent without prior approval would violate GCP and regulatory expectations, potentially making consent invalid and affecting the integrity of the study data. Once the IRB approves the revision, the new form can be used going forward, including for new participants and, depending on the changes, for current participants who may need re-consent. The other options fail because they rely on sponsor approval alone, suggest using revised material without prior review, or imply approval after use, all of which are not compliant with the requirement.