CITI - Updates to Expedited Review Procedures

The revisions to the Common Rule added a third statement about the use of expedited review for which of the following?

Limited IRB review

The Final Rule updated continuing review requirements to:

No longer require continuing review for research initially approved using expedited review procedures

The expedited review categories have:

Not changed

Under the Final Rule, a study is presumed to be minimal risk if it meets one of the categories of the HHS Secretary's list. If the expedited reviewer determines that the study involves more than minimal risk, what can the reviewer do?

Override the minimal risk presumption

A research study is initially approved via expedited review under the pre-2018 rule. After the Final Rule's general compliance date, this ongoing research study:

Would require continuing review