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New IBC Protocols & Renewals

A new IBC protocol is required for all new research proposals that involve work with r/sNA molecules, biological toxins, infectious agents, or for human gene transfer clinical trials. IBC applications are approved for a period of three years and are contingent on the submission of annual continuing reviews. After approved protocols are active for three years, you must submit a new protocol (which can be cloned from your current protocol) for review. While this is referred to as a "three-year renewal," it works the same way as submitting a new protocol.

You must submit all new applications (including three-year renewals) through eprotocol.umn.edu. For the purpose of IBC applications, principal investigators are defined/described in a University of Minnesota Regents policy.

Prior to panel assignment, OBAO/IBC administrative staff reviews new submissions as time permits. The OBAO/IBC administrative staff offers assistance in 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.

For assistance with the eProtocol system and in completing a new protocol:

For assistance with post-approval submissions review the Amendments and Annual Continuing Review sections.
 

Creating New Protocols

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. 

Cloning & Renewals

Purpose of Cloning

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. 

Submit a Three-Year Renewal

Submit a clone of the previous 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.

When you clone a protocol, it will generate a new unique protocol ID. 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.

Failing to Complete a Renewal

If you allow the 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 ibc@umn.edu or 612-626-2161 for guidance on reactivating a study.