Exempt Review: IRB protocols that have received an Exempt Determination after 2022 do not require Continuing Review.

Expedited Review: Unless an IRB determines otherwise, continuing review of research is not required for research eligible for expedited review. However, if it is deemed necessary, the IRB Member Reviewer may require a Continuing Review for a protocol undergoing Expedited review (up to one-year approval).

Many protocols do not require continuing review. To determine if your project requires a continuing review, there will be an expiration date on the approval letter. If there is no expiration date, your project does not require continuing review.

• Expedited protocols that have been approved prior to November 1, 2021 must submit their next scheduled annual Continuing Review/Progress Report in order for the IRB Member Reviewers to determine if an annual Continuing Review/Progress Report will be required moving forward.  If a Continuing Review is not required, the protocol information will be updated to remove the expiration date and the appropriate Expedited Approval Letter will be published.
• All protocols approved after November 1, 2021 will not have expiration dates unless the IRB Member Reviewer has indicated that a Continuing Review is required.  If a Continuing Review is required for your Expedited protocol, your IRB Approval Letter will include language about completing a Continuing Review prior to the expiration date of the protocol.
• Expedited protocols that are not required to submit a Continuing Review will be placed into an algorithm developed by the IRB Quality Assurance Program.  The algorithm will randomly select a sampling of Expedited protocols. The Quality Assurance Analyst will contact the PI for any study selected through this algorithm and will request a Progress Report be completed for the study. This is meant to act as a check-in on the progress of the Expedited protocol and compliance with the approved protocol.

Full Board Review: Protocols deemed greater than minimal risk and some deemed minimal risk but reviewed by the Full Board will be approved for up to one year. If you plan to continue obtaining data from human subjects or collecting or analyzing identifiable private information for your research project, a Continuing Review application must be reviewed and approved by the IRB prior to the Expiration Date. Please check the Full Board Review meeting dates that are posted on the IRB website to ensure the Continuing Review is submitted by the application deadline.

• Approximately 30-45 days before the expiration date
  • IRBNet will alert you when your project is near expiration.
• If the application is submitted shortly before the expiration date, this does not guarantee the application will receive IRB Approval before the protocol expires.
• If the protocol does expire after a Continuing Review Application has been submitted, all research activities involving human subjects must cease until approval is granted.
• If a Continuing Review Application is not received by the IRB prior to the Expiration Date, the protocol will expire and a new Initial Protocol Application must be submitted and approved in order to continue human subject research activities.

• To submit a Continuing Review Application, you will need to complete the appropriate Continuing Review Application.
• Additionally, if the study will remain open to enrollment, please update the package number to the footer of the Consent Form to reflect the package number under which this Continuing Review will be submitted.
• Create a new package and submit the Continuing Review Application and the updated Consent Form with the new package number in the footer to the IRB (if applicable).
• Be as specific and clear as possible regarding the total number of participants enrolled, study progress to date, protocol, risk, and deviations (if any)
• Once the application is complete and the supporting documents are attached, have the IRB Liaison review and sign off on the package.

The IRB does not recommend submitting amendment requests during the continuing review process as this will increase the turnaround time for these applications. However, if the requested modifications are minor (for example: editorial or research staff changes) please make the changes to the appropriate section of the protocol and clearly identify the changes in the Continuing Review Application. In certain cases the IRB will make an exception to this policy, please contact the IRB with questions.