Which statement correctly describes expedited review for minor changes?

Which statement correctly describes expedited review for minor changes?

• 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 applies to small amendments that don’t increase risk to participants and don’t change the study’s scope in a way that would require full board discussion. When a trial is already approved by the IRB, minor changes can be reviewed and approved through an expedited process, and the IRB’s favorable opinion remains in effect. This keeps trials moving without sacrificing oversight whenever the amendment is truly minor. So this statement is correct because it reflects that ongoing trials with IRB approval can use expedited review for minor changes, rather than requiring a full IRB convened review. Major changes or changes that affect risk, consent, or study scope would still need full board review, and no IRB involvement would not be appropriate for amendments.

Expedited review applies to small amendments that don’t increase risk to participants and don’t change the study’s scope in a way that would require full board discussion. When a trial is already approved by the IRB, minor changes can be reviewed and approved through an expedited process, and the IRB’s favorable opinion remains in effect. This keeps trials moving without sacrificing oversight whenever the amendment is truly minor.

So this statement is correct because it reflects that ongoing trials with IRB approval can use expedited review for minor changes, rather than requiring a full IRB convened review. Major changes or changes that affect risk, consent, or study scope would still need full board review, and no IRB involvement would not be appropriate for amendments.