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All new and three year renewal IBC applications must be submitted using eProtocol available at eprotocol.umn.edu.
The job aids and information on this help page are specific to IBC eProtocol applications. All include page-specific screen shots and instructions.
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NEW: Only one title is needed for applications! The “Funding” section is where Sponsored Project Administration (SPA) searches to ensure funding for IBC projects. Title matches are no longer used.
Navigation tips including finalizing your submission
Administrative Return Notes
Reading and responding to notes requesting additional information for review
Response to Comments/Stipulations
Reading and responding to Comments/Stipulations
Event History and Print View
View historical and current information about your application
NEW: Changes cannot be initiated for any protocol with pending Amendments or Annual Continuing Reviews. See job aid below for assistance in deleting amendments initiated, but not submitted.
Initiate and complete Amendments (Including funding, personnel and location changes)
Delete pending Amendments
Annual Continuing Review
Initiate and complete Annual Continuing Review
Don't let your IBC approval be delayed because you forgot something! The most common errors occur when IBC applications are not completed correctly, required attachments are missing or incomplete, or outdated forms are submitted.
Click on the panels below to learn how to address these concerns before submission and potentially shorten your approval timeline:
Detailed step-by-step experimental SOPs are needed for all experimental activities performed in your study (e.g. administration of infectious agents to animals, viral vector creation, cell transduction, etc.) for reviewers to understand and assess the proposed work. You must also describe any procedures that may present biosafety risks (i.e. centrifugation, use of sharps, etc.) and how you will mitigate these risks. Clear SOPs enable the reviewers to assign containment levels, determine NIH designations (for rDNA work) and address any biosafety issues. If SOPs are missing, unclear or inconsistent, your application may be deferred, requiring resubmission and review of your application in a later month. For information about writing biosafety SOPs, please refer to the following website:
The latest version of the Biological Decontamination and Spill Clean-up and the Biological Waste Disposal Plans should be placed in a prominent position in your lab. They should be clear enough for any laboratory staff member to identify the agents/rDNA/toxins used in your study, the required decontamination procedures, how to safely clean up accidental spills, how to safely dispose of liquid and solid waste, and who to contact in the case of an incident. These forms, along with your SOPs, provide clear guidelines that will enable your lab personnel to work safely and ensure consistency in laboratories. Due to important content changes made periodically to these forms, older versions will not be accepted. Link to the current versions in the “Attachments” section of the application, the IBC Forms page or through the DEHS website.
A schematic diagram and/or description of any vectors referenced in the “recombinant DNA” section must be submitted. These inform the committee about the safety features of each vector. The IBC does not accept entire manuals describing vectors, but vector maps may be extracted from manuals for submission.
Please refer to the table below for training requirements and links to on-line courses:
Who needs the training?
All laboratory staff
All laboratory staff working with rDNA
All laboratory staff working with infectious microorganisms, human blood, human body fluids, and/or human/primate cell lines.
All BSL-2 labs must be inspected annually, and all new BSL-1 labs must be inspected prior to the start of work. Please contact Xiaohong Chen, Biological Laboratory Specialist, of UHS at firstname.lastname@example.org or 612-626-5495 to schedule a biosafety inspection of your laboratory, if necessary.
Biosafety cabinets require annual certification. If your work requires use of a biosafety cabinet, final IBC approval will not be granted unless the certification is up to date. Information regarding biosafety cabinet certification is located at the following website:http://www.dehs.umn.edu/bio_pracprin_biosafecab_cert.htm
Be sure to specify the strain of bacteria you will use in the “Infectious Agents” section. The risks of different strains of bacteria vary widely, e.g. E. coli K12 is a lab strain while E. coli O157:H7 is pathogenic (infection can lead to kidney failure). Also, please provide any information available regarding antibiotic resistance or sensitivity. If antibiotic sensitivity profiles are available, be sure to attach these in the “Attachments” section of your application.
You must describe any host-vector system you intend to use in your study. A downgrade for a Risk Group 3 viral vector (e.g. lentivirus) may be considered, but justification must be provided to assure that BSL-2 containment is acceptable (i.e., low possibility of replication competent mutant generation, amount of sequence overlap, commercially available vector, etc.).
If you will be administering transduced cells to animals, please clarify the timeframe between cell transduction and administration to animals. Providing this information, in the “Study Objectives” section and/or SOPs, aids in determining the appropriate animal housing level and often leads to a housing downgrade.
Be sure to identify any potential for aerosolization, and describe how aerosolization will be minimized (i.e. secondary containment for centrifugation, using a biosafety cabinet when warranted, instructing for use of masks or N95s when needed, etc.).
The IBC meets monthly, typically on the third Monday of the month.
Researchers can expect to receive results of IBC review within 7-10 days after a meeting.