Medical School IRB Protocol Review Extension Program
What’s the Medical School IRB Protocol Review Extension Program?
Effective May 1, 2022, the University of Minnesota IRB instituted a new policy with the expectation that researchers respond to pre-review and review requirements within 30 days.
There are circumstances in which a study may require additional time to gather the information needed to address the IRB’s review. The investigator may request one 30-day extension from the IRB, but when additional time is needed beyond this IRB extension, approval from the college/campus research associate dean responsible for oversight will be required. The Medical School has assigned the review to the Research Office under Peter Crawford, Associate Dean of Research Operations and Mahrya Johnson, Director of Clinical Research Support.
Why Was This Extension Program Established?
The IRB metrics data show that the best predictors of a shorter turn-arond time (TAT) are a peer-reviewed protocol and a well-prepared IRB application. Generally speaking, peer-review of a protocol (e.g., NIH grant) improves the clarity of a research plan, and a well-written and complete IRB application always reduces TAT.
Another important predictor of TAT is PI response time: data show that about 50 percent of TAT is attributable to investigator delay in response to IRB requests for more information. While many investigator responses are rapid, others are delayed for several months. It is this side of the TAT equation that we seek to address.
While the submission may be in the investigator’s “court,” the issues to address may require action or decision by someone other than the investigator. Whether waiting for a sponsor to respond, or an ancillary review to be completed, the Dean’s office is committed to connect the investigator to the appropriate resources that will help address the regulatory step and/or refine the protocol.
How Do I Request An Extension?
To request a Medical School IRB protocol extension, please complete the following REDCap survey. Investigators are encouraged to submit requests at least 10 business days before the initial IRB extension expiration date to provide sufficient time for review, response and/or any additional communication.
Requests will be reviewed by the Medical School Research Office within 10 business days, and feedback will be provided as needed. Requests received on a Friday after 12:00PM central time will be reviewed the following business week. The Research Office cannot guarantee that requests submitted with a shortened window (<10 business days) for review will be finalized before the IRB Expiration Date.
All communication from the Dean’s Office will be sent directly to the Principal Investigator via email. It will be the responsibility of the investigator to submit their extension approval notification to the IRB via Ethos.