Continuing Review of IRB-Approved Research

  1. What is a continuing review and why is it necessary?
  2. What happens if I do not submit a continuing review?
  3. When should I submit a continuing review (CR)?
  4. How do I submit a continuing review (CR)?
  5. I tried clicking on a link to start a continuing review, but I got this message: "An active (modification, continuing review, closure form, etc.) exists for this project.  No new forms can be created."  What can I do?
  6. Why am I not prompted to attach any documents to my continuing review submission?

1.  What is a continuing review and why is it necessary?

Except for studies determined to be exempt from IRB oversight, all human subjects studies are subject to continuing review.  The IRB is required to review and approve all non-exempt research projects at intervals appropriate to the degree of risk, but not less than once a year [45 CFR 46.109(e) (DHHS) and 21 CFR 56.109(f) (FDA)]. This is called "continuing review." The continuing review for these studies is required to occur as long as the research remains active for long-term follow-up of the research subject, even when the research is permanently closed to the enrollment of new subjects and all subjects have completed all research-related interventions, as well as when the remaining research activities are limited to collection of private identifiable information.   The IRB, IRB Chair, or Chair Designee reviews the continuing review application submission form as well as the research project and applicable attachments in its entirety.  


2.  What happens if I do not submit a continuing review?

No further research related activity can occur on or after the date that the project expires. After approximately 24 hours, your project will be closed by the IRB. To be able to conduct this research again, you would need to submit a New Project Form and await IRB approval.

If suspending research activity may endanger subjects, please contact an IRB Chair immediately.  Continuation of research related interventions or interactions with already enrolled subjects is allowed only when the IRB or IRB Chair determines that it is in the best interest of individual subjects to do so.  For VA studies, this determination is made only in consultation with the VA Chief of Staff. The IRB notifies the sponsor of any VA studies for which the IRB does not grant continuing review.


3.  When should I submit a continuing review (CR)?

Continuing review applications should be submitted at least 21 days prior to the project's expiration (or lapse) date. Remember to allow sufficient time to respond to any questions or revisions when considering when to submit the CR application. For example, if a project expires on 9/26/10, it would be best to submit the CR application no later than 4:30 PM on 8/30/10. The principal investigator, delegates, and contact persons listed on the application will receive email notifications from HawkIRB when the research project is due for continuing review, starting 30 days in advance of the submission deadline. The deadline in the email notification should allow for sufficient time for IRB review of your project prior to its expiration.

The earliest a continuing review application may be submitted is 90 days prior to the project expiration date. Continuing review applications that are received prior to this window will be sent back to the principal investigator in workflow with a request to acknowledge that the application will be withdrawn. The continuing review application will be withdrawn from workflow and the application will need to be resubmitted at a later date.  

For projects that require full board review, please keep in mind that the Human Subjects Office makes a concerted effort to have expertise from every area at each IRB meeting. However, the HSO reserves the right to move a project to another meeting if a board member with that particular expertise is not available to provide a complete review of the application.  Also, during holiday seasons or during particular high traffic months, there is a possibility that the continuing review for a project could be moved to another scheduled IRB meeting. Every effort will be made to schedule a project to be reviewed prior to its expiration date. Please call the Human Subjects Office at 335-6564 if you have questions regarding Full Board meeting scheduling.    

To check the project's expiration date, open the Project Summary page in HawkIRB and review the Next Approval Due By date.  

4.  How do I submit a continuing review (CR)?

  •  Log into HawkIRB.
  •  Under Projects, click on the appropriate IRB number to route to the Project Summary page.
  •  Under Create Form in the upper right corner, click on Continuing Review Form. (You can also propose a change to your research procedures and submit a CR by clicking on Modification/Update + Continuing Review Form.)
  •  You will be routed to the Continuing Review Index - click on the first link to access CR.1 and begin answering the questions. Be sure to click on Back, Index, or Continue to save your answers.
  •  You do not have to complete the CR at one time. If you do not submit it, the next time you log into HawkIRB you will see this CR listed under Draft Forms in your HawkIRB inbox.

5.  I tried clicking on a link to start a continuing review, but I got this message: "An active (modification, continuing review, closure form, etc.) exists for this project. No new forms can be created." What can I do?

  •  Log into your HawkIRB inbox.
  •  Under Draft Forms, you should see this project listed. Look to the form Type at the far right of this line.
  •  Click on the project title if you wish to continue this form.
  •  Click on remove (far right) if you wish to delete this form.   You will be asked to confirm this.

6.  Why am I not prompted to attach any documents to my continuing review submission?

A "yes" answer to a question within CR III.9-12 will elicit a corresponding attachment category (such as a progress report or a competitive continuation grant). If you answer "no" to these four questions, you will not be prompted to attach any documents to your CR submission. All currently approved consent and recruitment documents will automatically be updated with a new IRB stamp when the CR is approved.

Consent and recruitment documents should NOT be attached to your CR submission. If you need to modify one of these documents or add any new documents other than a progress report or competitive continuation grant, you should change the form to a modification + continuing review.