In 2021, the IU Institutional Biosafety Committees (IBCs), supported by the Office of Research Compliance (ORC), completed evaluation and started planning for the implementation of a cloud-based electronic system for protocol submission, review, and approval. Kuali Protocols is now live for all protocol submissions to the Bloomington and Indianapolis IBCs. The new online system enhances the user experience and is designed to be user-friendly, making the process of submitting protocols easier and paving the way for a quicker review and turnaround. KuaIi Protocols is already used for IRB protocol submissions.
Need to update your IBC protocol or ready to submit a new protocol?
Limited general information about all active protocols has been transferred (i.e., migrated) into the Kuali Protocols system on your behalf. Items such as research personnel, research locations, and sections of the NIH guidelines have been transferred. All other information will need to be manually transferred from your paper protocol into Kuali Protocols during your first submission in the system.
The new Kuali Protocol (KP IBC) system calculates renewal date based on the month and day of the original approval. Even if you recently had a continuing review or continuing review with an amendment on the Word document you will still need to take renewal action on your KP IBC protocol before the expiration date.
The new system features a user interface that only presents relevant questions based on the user's type of research. This built-in smart logiccaptures experimental details succinctly and concisely. The system improves the experience of managing protocol reviews, retaining protocol records, and amending and renewing protocols. Researchers will always have access within the system to the approved copy of their protocols and can submit updates for review at the click of a button.
There will be a short moratorium on submitting items immediately prior to KuaIi Protocols implementation. Plenty of notice will be provided before this occurs, so it should have minimal effect in terms of delaying review and approval of protocol submissions. After implementation, new protocols and amendments to existing protocols will be submitted in the Kuali Protocols system.
Upon logging into Kuali Protocols you will be taken to the Manage Protocols screen. On this screen you will see a list of all Kuali Protocols you are personnel on. This list will include IRB and IBC protocols.
If you would like to only see IBC protocols, you can use the Advanced Filter feature and set your Filter Rules to Where - Type - is equal to - IBC. The same feature can be used to filter for only IRB studies by replacing IBC with IRB in the Advanced Filter..
Exempt and Non-Exempt refers to whether the work falls under the NIH Guidelines for Recombinant and Synthetic Nucleic Acid Molecule Research. Non-exempt research is any research that falls under sections III-A through III-E of the NIH Guidelines. Other research, such as work that only falls under section III-F or does not fall under the NIH Guidelines, is considered Exempt from the NIH Guidelines. Both Exempt and Non-Exempt research requires IBC protocol submission. If you are still unsure if your research is Exempt or Non-Exempt please reach out to the IBC Office (email@example.com).
Your protocol will undergo an annual review at the end of years 1-4, during the month in which your initial protocol was approved. The purpose of the annual review is to ensure that all information on your protocol is up to date and to verify that all work has been conducted in accordance with the approved protocol.
At the end of the 5th year, your protocol will be re-reviewed in full without requiring the submission of a new protocol. When the protocol is reapproved, the protocol number will remain the same and the 5-year cycle will begin again.
General information about the types of host cells/cell lines, tissues, blood/blood products, and viral vectors should be included in the Biological Materials section. Cell lines, tissues, blood/blood products, or fluids for a single species should be entered as one row in the Biological Materials list. For example, if a researcher is using both HeLa cells and HEK293 cells, they should list “Human Cells” as one row. If a researcher is using both human blood and tissue, they should add an entry for “Human blood or blood derivatives” and a separate entry for “Human tissue.” The researcher may describe the individual lines or specifics about materials in the Research Description.
Each strain of microorganisms, bacteria, viral vector particles, or virus must be listed in an individual row in the Biological Materials list. There is a link in the first question in the Biological Material(s) section that can be used to see a full list of biological materials that can be entered in the table.
Get help with your IBC protocol submission
Watch your email for weekly Zoom drop in hours or schedule time for help with a submission Monday through Friday from 9 am to 4 pm until the end of November.