New IBC Protocols & Renewals

IBC approval is required for new protocols involving activities that use recombinant or synthetic nucleic acid molecules, infectious agents, biologically derived toxins, and human gene transfer clinical trials. See our IBC Application eProtocol Instructions & Guidance which provides a detailed explanation of each section of the eProtocol application. See the eProtocol page for more information on the eProtocol system. Please note, that page specific application assistance can be found by clicking on the “Help” button in the upper right corner of the eProtocol application.

For the purpose of IBC applications, Principal Investigators are defined/described in a University of Minnesota Regents policy. To create a new protocol, the Principal Investigator should:

1. Select the “Create Protocol” button in eProtocol.
2. Enter a Study Title in the text box.
3. Check the box for “IBC.”
4. Select the icon for Study Submission.
5. Enter a Co-Investigator or PI Lab Admin Contact. See our Personnel Information page for more information on eProtocol capabilities these roles offer.
6. Click the “Create” button.
7. A new window will open with your IBC application. Please be sure to have pop-up blockers disabled. The new application can also be found under the NEW Protocols (In Preparation/Submitted) section of your IBC tab in eProtocol.

Cloning can be used to make three-year renewals easier, but can also be used as a template for new protocols that will have common elements, including personnel, standard operating procedures (SOPs), etc. When you clone an application, it will create a new and unique IBC protocol ID. Detailed Instructions describing the cloning process can be found in our Job Aid: IBC eProtocol Cloning and Navigation.

Submit a clone of the previous, expiring IBC application in eProtocol for full committee review at least two months before the expiration date to avoid a lapse in approval. See Meetings and Submission Deadlines.

You may clone the previous protocol and revise with updated information instead of recreating the entire protocol. We will send instructions for how to do this within your automated renewal notice email. Please be aware that section requests may have updated wording in the newly cloned application so each section should be reviewed to ensure that any transferred information from an expiring application is relevant to any potential new wording within the application.

Even after a renewal has been submitted, eProtocol will continue to send automated expiration notice emails. If you have successfully submitted your renewal application, you can disregard these expiration notice emails. The protocol event column in eProtocol will say “SUBMITTED” if the application was successfully submitted in the system. See the Post Submission Process for more details on how to check the status of the application.

Prior to panel assignment, OBAO/IBC administrative staff reviews new submissions as time permits. The OBAO/IBC administrative staff offers assistance in the development of the IBC protocol and provides outreach to IBC committee members for expertise in special containment or procedure requirements. If a submitted protocol or amendment requires more information or clarification, we will return the protocol with comments requesting clarification and/or corrections. This helps to prevent protocols from being deferred or stipulated for common problems.

The Administrative Return Notes Job Aid explains how to access return notes and resubmit the protocol. All returned protocols must be resubmitted in eProtocol for our review.

If you allow a protocol to expire, we will classify the study as "inactive." All activities involving recombinant/synthetic nucleic acid (r/sNA) molecules, infectious agents, and biological toxins must cease if you have a lapse in IBC approval. Contact us at [email protected] or (612) 626-2161 for guidance on reactivating a study.