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eProtocol help

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.

Pop-Ups

eProtocol requires your web browser's pop-up blocker to be either be disabled or allow the site as an exception. This article will walk you through managing your web browser's pop-up blocker. eProtocol works best using the browsers Firefox or Safari. Do not use Chrome.

Protocol creation and submission

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.

Protocol Navigation
Navigation tips including finalizing your submission

Administrative Return Notes
Reading and responding to notes requesting additional information for review

After review

Response to Comments/Stipulations
Reading and responding to Comments/Stipulations

Event History and Print View
View historical and current information about your application

After approval

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.

Amendments
Initiate and complete Amendments (Including funding, personnel and location changes)

Delete Amendment
Delete pending Amendments

Annual Continuing Review
Initiate and complete Annual Continuing Review

Top 10 common application omissions

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errors occur when IBC applications are not completed correctly, required attachments are missing or incomplete, or outdated forms are submitted.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:

1. Standard Operating Procedures (SOPs) for all activities


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:
http://www.dehs.umn.edu/PDFs/writingSOP.pdf

2. Current Biological Waste Disposal and Biological Decontamination Spill-Clean-up Plans


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.

3. Vector/plasmid maps for rDNA submissions


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.

4. Required training


Please refer to the table below for training requirements and links to on-line courses:

Who needs the training?

Course

All laboratory staff

Biological Safety in the Lab

All laboratory staff working with rDNA

Implementation of the NIH Guidelines

All laboratory staff working with infectious microorganisms, human blood, human body fluids, and/or human/primate cell lines.

Bloodborne and Other Pathogens

The “Personnel Information” section should reflect Biological Safety in the Lab, Implementation of the NIH Guidelines and Bloodborne Pathogens (Introduction and Advanced) training for all personnel but the connection with ULearn training records is inconsistent. If personnel have taken the training but it isn't listed, please include the training module name(s) and date of completion for each in the box for "training that is not indicated above" for all personnel (click on their name).

5. Laboratory inspections


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 chenx448@umn.edu or 612-626-5495 to schedule a biosafety inspection of your laboratory, if necessary.

6. Biosafety cabinet certification


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

7. Strain and/or sensitivity profiles of bacterial agents


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.

8. Justification for downgrading from BSL-3 to BSL-2 containment


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.).

9. Clarifying time between cell transduction and administration to animals


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.

10. Aerosol generation


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.).


Committee meetings

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.