–Effective January 2019–
As part of the new regulations, annual continuing reviews are eliminated for all new expedited studies approved on or after January 21, 2019, unless the IRB determines that a continuing review should be required for a specific study.
Instead, we will follow a process similar to the current process for exempt studies, where we will request an email to let us know whether the study is still ongoing or not. We will ask for this update each year.
For expedited studies approved prior to January 21, 2019, the old regulations will continue to apply and annual continuing reviews will be required.
All full board (more than minimal risk) studies will still need annual continuing review approval until all enrollment and data collection is complete. Continuing review will not be required for full board studies where the only remaining activity is data analysis.
For IRB members
The reviewer checklist has been updated to include a question about whether or not continuing review should be required. If you indicate that continuing review should be required, you will also need to provide a justification for this decision.