Under what conditions may expedited review be provided for minor changes in ongoing trials?

• A. For major changes that require full board review
• B. For minor changes in ongoing trials without any IRB involvement
• C. Expedited review is not allowed for any changes
• D. Expedited review and approval/favorable opinion of minor changes in ongoing trials that have the approval/favorable opinion of the IRB/IEC

Answer: (D)

Expedited review is for small, non–risk‑increasing changes to a study that is already approved. If a modification is truly minor and does not add risk or alter the consent in a significant way, it can be reviewed and approved quickly without convening the full IRB. The essential point is that the trial must already have IRB approval and the proposed change must receive the IRB/IEC’s favorable opinion through the expedited process before it can be implemented. Larger, major changes that could affect risk, rights, or welfare still require review by the full board. And changes cannot be implemented without IRB involvement, so there is no expedited path if the IRB hasn’t reviewed the amendment.