How do I submit a continuing review?
Log in to eIRB+ using your NU NetID and password. Navigate to the study for which you wish to submit a continuing review request. On the left-hand side of the study workspace, click: Create Modification / CR” and select “Continuing Review.” (Note that you may also submit a combined Modification and Continuing Review. See the section “How do I submit a modification?” for additional information.) Complete all Continuing Review / Study Closure Information. You will not be able to make any changes to your study at continuing review unless you submit a combined Modification and Continuing Review. Before submitting the research for continuing review, you should verify the current list of research team personnel, whether their human protection training is current, and if there has been any change in financial interest related to the research.
As of August 31, 2018, the IRB may approve non-exempt minimal risk, non-FDA regulated studies without setting an expiration date for IRB approval. As a result, these studies no longer require an annual continuing review. For more information, see “SOP: Determining and Processing When Continuing Review is Required (HRP-033).”
If the approval of Human Research includes an expiration date for IRB approval and thus the requirement of Continuing Review, and if the study approval expires, you must cease all Human Research procedures. These procedures include recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collecting or analyzing private identifiable information. Continuing Human Research procedures after approval expiration is a violation of institutional policy. It is considered non-compliance to allow your studies to lapse in IRB approval.
If current participants will be harmed by stopping Human Research procedures available outside the Human Research context, provide these on a clinical basis as needed to protect current participants. If current participants will be harmed by stopping Human Research procedures that are not available outside the Human Research context, immediately contact the IRB Office and provide a written list of the currently enrolled participants and why they will be harmed by stopping Human Research procedures. Please note that reportable non-compliance may include human participant research conducted without IRB approval, enrollment of participants before IRB approval has occurred and after IRB approval has lapsed, and continued treatment of participants after IRB approval has lapsed without first obtaining permission from the IRB. See the IRB Office’s Reportable New Information (RNI) Page to document and determine reportability.