What is the purpose of expedited review by the IRB/IEC?

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Multiple Choice

What is the purpose of expedited review by the IRB/IEC?

Expedited review is a faster, focused IRB/IEC review path for changes that don’t raise risk or alter participants’ rights in a previously approved study. It lets the board or a designated reviewer approve minor amendments without convening the full board, keeping the study moving while maintaining oversight. This question targets that idea: expedited review is used for minor changes in ongoing trials that already have approval, because such changes are unlikely to increase risk or affect participants’ welfare. It’s not meant for major protocol shifts, new trials seeking initial approval, or changes that substantially raise risk, all of which require full board review.

Expedited review is a faster, focused IRB/IEC review path for changes that don’t raise risk or alter participants’ rights in a previously approved study. It lets the board or a designated reviewer approve minor amendments without convening the full board, keeping the study moving while maintaining oversight.

This question targets that idea: expedited review is used for minor changes in ongoing trials that already have approval, because such changes are unlikely to increase risk or affect participants’ welfare. It’s not meant for major protocol shifts, new trials seeking initial approval, or changes that substantially raise risk, all of which require full board review.

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