https://irb.northwestern.edu/compliance-education/post-approval-monitoring.html
In addition, IRB staff will be doing random file reviews in the future to further ensure that research is being done in accordance with approvals.
Continuing Review
When a study is nearing its expiration date, you must submit a renewal request, also known as a continuation, in order to continue with the research. The renewal will need to be approved before you can continue with the study. A study renewal may be required for certain studies and under certain circumstances. All Full-Board approved studies are required to be renewed not less than once a year and are issued an expiration date. Most Expedited and Exempt studies are not required to be renewed and are not issued an expiration date unless the IRB decides there is a reason to monitor a study.
All Expedited and Full Board studies approved before January 1st, 2019 will have been issued an expiration date and must be annually renewed or formally closed. All studies approved before January 1, 2024 that have been issued an expiration date will continue to use the previous paper/email submission system.
Projects for which approval has expired are in non-compliance with federal regulation and UM IRB policy, and all work must cease.
How to Submit a Renewal/Continuation
Cayuse HE
Studies submitted through Cayuse HE will automatically receive a 90-, 60-, and 30-day notification prior to their study expiration date. Principal Investigators are responsible for keeping track of their study expiration date. Please see the Cayuse Application Guide for step-by-step instructions on how to submit a renewal.
Paper/Email System for Studies Approved Prior to January 1, 2024
PIs who are submitting continuations for studies that were approved prior to the Cayuse HE system will receive a notification from the IRB office at least 30 days prior to the expiration of their approval. This notification is simply a courtesy; Principal Investigators are responsible for keeping track of their own study expiration date. To submit a continuation/renewal using this method, download, complete, and submit the Continuation / Closure Report (form RA-109), located on our Forms, Templates, and Examples page.
Study Closure
If your study was issued an expiration date, then it must be formally closed when at least one of the following situations occurs: the research is completed; when analysis is limited to de-identified data only; or if the project has been abandoned or significantly postponed.
A research project no longer involves human subjects once the investigators have finished obtaining data through interaction or intervention with subjects or obtaining identifiable private information about the subjects, which includes the using, studying, or analyzing identifiable private information. Once all such activities described in the IRB-approved protocol are finished, the research project no longer needs to undergo continuing review and may be closed. For example, when the only remaining activity of a research project involves the analysis of aggregate data sets without individual subject identifiers, no further continuing review is necessary. At that point, the IRB can formally close the IRB file for the project and advise the investigator of that action.
Similarly, simply maintaining individually identifiable private information without using, studying, or analyzing such information is not human subjects research and thus does not require continuing review. If a study is in data analysis only AND the Project Director has destroyed all private information about the subjects, the IRB can be notified and they will close the study.
All signed Informed Consent forms must be retained by the PI for at least 3 years after completion of the research, per federal regulation [45 CFR 46.115(b)]. The forms must be stored in a secure, locked location separate from the de-identified data.
If you need to close your study, you can do so by completing a Study Closure submission.
A closure submission indicates that the research is complete and will not be continuing. Closed studies are marked as finalized and can no longer be modified.