Annual Reports & Continuing Review

Annual Reports

Annual reports are short status reports required for all projects approved under Full review. Under the new final rule that went into effect in January 2019, Expedited reviews do not require an annual report and continuing review, unless specified by the IRB. IRB approval for these projects expires after one year. You will receive a reminder email from Mentor that IRB approval is going to expire and the Annual Report is due 7 weeks prior to the approval expiration date. Exempt status projects do not have to submit an annual report.

Annual Reports are required whether the project is closed or continuing. The purpose of the Annual Report is to keep the IRB apprised of the status of the project and to either 1) request continuing review to extend the project another year or 2) terminate the project. Until the PI completes the Annual Report with request for continuing review or termination, a “Past Due” notice will block the PI from submitting new applications or amendments. If the study has been completed, to include data analysis and publication, this review serves as a reminder that PIs should close the loop and notify the IRB that the study has closed.

To complete the Annual Report, login to Mentor, open the relevant application and locate the tab at the bottom of the screen labled “Annual Reports.” Under this tab there is a small, red report icon next to the due date. Click on the icon and then click “Complete and Submit.” Fill in the information requested in the form that appears, including whether you wish to continue or terminate the project, and then click “Submit Report.”

Continuing Review

Exempt status research may continue indefinitely without continuing review; however, approval for all Expedited and Full review research expires after one year. Continuing review is required to extend the project beyond the expiration date. While initial IRB review is based on the researcher’s best assessment of the anticipated benefits, risk, and procedures, continuing review is important because it is based on the conduct of the study; actual risk can be evaluated and preliminary results used to assess the risk/benefit ratio. In addition, the risk/benefit ratio may change not only because of unexpected results and effects of the research intervention itself, but because new knowledge resulting from related research may affect the balance. The continuing review process also provides an important opportunity to ensure that changes in federal or state policy and Marymount IRB policies are reflected in the ongoing project.

How do I extend IRB approval beyond the expiration date?
You will receive a reminder email from Mentor that the approval is going to expire 7 weeks prior to the expiration date. If you wish to continue the project, you must complete the Annual Report requesting to continue the project at least three weeks prior to the expiration date to ensure the IRB has time to complete the continuing review.  See directions above for completing the Annual Report. In this report indicate that you are requesting continuing review.  The IRB will review your request and notify you within ten business days of the outcome.

What happens if I didn’t request continuing review before the IRB approval expired?
Once IRB approval expires all data collection and analysis must cease.  Depending on the length of time that has passed since expiration, you may be required to resubmit the entire application. Contact the IRB Chair immediately to discuss your options for obtaining approval to re-start the project.