Annual reviews are required for any study approved as expedited or sent to full board review. The RCM (Research Compliance Manager) will send reminders to PI or grant administrators 90, 60 and 30 days before the study expires. OHRP (45 CFR 46.103(b)(4)) requires the following be reported for the annual review:
- A brief project summary
- Subjects accrued (if applicable)
- Summary of amendments (if applicable)
- Changes to risk
Materials sent to a PI's home University's IRB for annual review may be submitted to the NBER IRB. If the study expires it will be administratively closed by the RCM and a letter sent to the PI to that fact. The study may be re-opened by the PI at that point.