Continuing Reviews
Description
Continuing Review for Re-approval of Research
All open studies must provide information to the IRB periodically. Any study with an expiration date must be re-reviewed by the IRB prior to the expiration date to determine if the study can be re-approved according to the Criteria for IRB Approval of Research.
The study’s expiration date can be found on the most recent IRB approval letter. OPRS tries to send a reminder to the PI and appropriate contacts that a Continuing Review application is due; however, the PI and research team should independently track expiration dates of studies.
Submission timing and rules for automatic study closure
Continuing Review applications should be submitted 8 weeks before the study expiration date to ensure the study does not expire before renewed approval.
If the Principal Investigator has not completed study enrollment and/or procedures and the study expires, he/she must immediately cease enrollment and all other activities related to the study.
If the study expires before a Continuing Review application is submitted, the study will be administratively closed. If a study is closed before the study is complete, a New Study application must be submitted to the IRB to continue research activities.
The investigator may not continue until he/she has received IRB approval to do so.
Submission Requirements
The Continuing Review application must describe the following:
- progress of the study
- enrollment and withdrawals
- adverse events, complaints, and other problems that have occurred
- safety monitoring results, if applicable
If enrollment remains open for the study, a clean unstamped version of the consent documents should be included with the application for a new stamp upon application approval.