Continuing Review

In compliance with federal regulations (45 CFR 46.109(e)) and 21 CFR 56.109(f)) the IRB reviews and approves all non-exempt research projects at intervals appropriate to the level of risk to subjects, but not less than once per year. The timeframe for IRB approval is included in the Approval Memo. The IRB approval expiration date is also indicated under “Review” on the Project Summary Page. IRB approval expires at one minute after midnight on the expiration date.

Biennial Review

Some research projects qualify for an institutional check in every two years. The Biennial Review form has fewer questions than the Continuing Review form. The Biennial Review form may not be paired with a Modification form. If there are changes in the research team, study procedures or attachments, it is best to submit a Modification form and obtain IRB approval before the Biennial Review form due date.

HawkIRB Notifications

The earliest date to submit a Continuing/Biennial Review form is 90 days prior to the expiration date. Human Subjects Office staff will return forms submitted prior to this window and request confirmation for withdrawal of the form. The form will need to be submitted within the appropriate window. 

The HawkIRB system sends notices about Continuing Review or Biennial Review to the PI, their HawkIRB Delegates for the project and all contact persons on the research team. The notices provide a deadline for submission that is 30 days prior to the expiration of IRB approval to allow time for IRB review. Notices are sent on the following schedule prior to the expiration date:

  • 90 days
  • 30 days
  • 14 days
  • 7 days
  • 1 day
  • The day of expiration of IRB approval – The research team must stop all study activities and must not work with any identifiable study data.

The Human Subjects Office does not receive these notifications. For Continuing/Biennial Review forms that have been submitted for IRB review, respond to workflow in a timely manner and contact the Human Subjects Office ( when it gets within 2 weeks of the expiration date.

HawkIRB Submissions

The PI or their HawkIRB Delegate can generate a Continuing Review or Biennial Review form on the Project Summary page.

  1. Log in to HawkIRB
  2. Under “Projects,” click the IRB number
  3. In the “Create Form” box, select Continuing Review form or Modification Update + Continuing Review form [NOTE: This is not an option for Biennial Review forms]
  4. From the Continuing Review Index, begin in the white box for Section CR.I
  5. Click one of the Save buttons to save content added to each page.

To maintain IRB approval for the project, submit the Continuing/Biennial Review forms as soon as possible after receipt of the initial notice.


Based on the response to Sections CR III.9-12, attachments may be required. Attach all required documents to facilitate the IRB review process. Provide justification if the external monitoring or Data and Safety Monitoring Board reports are not attached.

The IRB approves all attached documents at the time of the Continuing Review. If revisions are required, submit a Modification form. Do not attach consent documents and recruitment materials to the Continuing Review form.

All consent documents and any stamped recruitment materials will have a new IRB approval stamp when the Continuing/Biennial Review is approved. Begin using the new stamped documents immediately after the Continuing Review form is approved and released by the IRB. The PI should have a plan in place to notify all team members about IRB approval of Continuing Review and Modification forms. Failure to use the current, approved documents is considered an incident of noncompliance and would require submission of a Reportable Event Form.

Error message about an active form

 You will receive an error message if you try to generate a Continuing/Biennial Review or Modification form when there is already a draft form started for that project. Click on the form title to use the existing draft form (in the Draft Forms section of the PI’s inbox) or click “remove” (far right side of the screen) to delete that draft and then generate a new one on the Project Summary page.  

Continuing/Biennial Review by Review Type

Continuing review requirements vary depending on the type of IRB review:

Full Board Review

At the time of approval, the IRB determines the appropriate length of time for approval. The PI must submit a Continuing Review form in the HawkIRB system following the schedule set by the IRB. Non-federally funded, non-FDA regulated research may qualify for a Biennial Review if the project is closed to enrollment and all study procedures are completed; just open for analyses.

Expedited Review

Projects reviewed via the expedited review process may qualify for Biennial Review to ensure the project is still active.

Exempt Status

Projects that qualify for exempt status are not required to submit a Continuing Review or Biennial Review form.

After IRB Approval Expires

If IRB approval is not received by the expiration date, all research activity must stop. There should be no data collection or study procedures. The research team should not work with any identified data (which includes coded data for which there is a link between the ID code and subject identifiers) until IRB approval is granted and the Continuing/Biennial Review form is released.