Hello, Kuali
Kuali Protocols is the primary protocol management system for the USU IRB. It went live in February 2020, and will eventually fully replace Protis. For now, Active Protis protocols will remain in Protis through Spring 2023. This page features systems notices, FAQs about using Kuali Protocols, and other useful information about working in that system. Click the button below to go to Kuali Protocols, or explore this page to obtain more information about the system.
Systems Notices
Frequently Asked Questions
Transitioning to Kuali
Q) Why did the IRB switch to Kuali Protocols?
A) Kuali was adopted to increase consistency across Office of Research user interfaces. Most Kuali products are still relatively new, but over time additional features will be added to make it a significantly more responsive and robust interface than Protis. Sponsored Programs, IACUC, and the Research Integrity office are also currently using Kuali.
Research Personnel
Q) Why can’t I locate my students in Kuali? Why can’t my student begin their own protocol?
A) Students who are not employed by the university are not automatically given access to Kuali and must be added by the Office of Research Systems Analyst. If you have students you would like to add, there is no need to wait until it’s time to file your protocol! You can email a list of names, email addresses, departments, and A numbers to dan.perry@usu.edu.
Q) Why can I only add a PI to the protocol?
A) When you are first “registering” your protocol in the system, only the PI’s information is requested. You will be able to add the remaining personnel, including yourself if you are not the PI, two screens from that one.
Q) The personnel fields are giving me errors when I try to switch the PI role. What do I do?
A) Unfortunately, this is happening quite often. Kuali is aware of the issue and is working to correct it. Our office has found that if you move on to another part of the protocol and continue your work, the issue seems to correct itself as the protocol autosaves. If it does not, please email irb@usu.edu with your protocol number and a screen shot, and our office will submit a ticket to Kuali for assistance. (P.S. – your protocol autosaves every 10-20 seconds!)
Q) Who needs to be added to a protocol?
Any researcher who meets the definition of “investigator” should be included in your protocol submission. An investigator can be someone whose involvement may include any of the following:
- Obtaining information about living individuals by intervening or interacting with them for research purposes;
- Obtaining identifiable private information about living individuals for research purposes;
- Obtaining the voluntary informed consent of individuals to be subjects in research; and/or
- Studying, interpreting, or analyzing identifiable private information or data for research purposes.
Q) Can a student researcher be listed as the PI?
A) At Utah State University, student researchers cannot be listed as PI’s on a research project.
Every aspect of the research must have appropriate and consistent oversight by the Principal Investigator. Per USU policy, only individuals with research role statements are permitted to maintain responsibility for the performance of a study, the protection of the rights and welfare of the human subjects, and strict adherence by all research personnel to all Institutional Review Board (IRB) requirements, federal regulations, and state statutes for human subjects research. There is an alternative route to allow a staff or faculty member to serve as a PI who might not have research in their role statement; please email us at irb@usu.edu for details on this process.
Managing a Kuali Protocol
Q) How does choosing a protocol type work in Kuali Protocols?
A) In Kuali Protocols, researchers have the freedom to request their protocol submission types, or to simply ask the IRB to apply the correct review type. Information about review types is provided within the protocol template. Reliance Agreements are also integrated into the submission system. Please note that changing your review type will populate different fields to your protocol, which will delete all data you previously entered into that submission. If you have input substantial information into your protocol, it is best to simply start a new protocol with the new review type you might wish to pursue.
Q) Which protocol type is appropriate for my research?
A) A very detailed description of the exemption categories is available on the Common Rule Basics page. If your protocol is not exempt, you do not need to choose between Expedited or Convened IRB; your scientific reviewer will make that determination, so those protocol types are combined. You can review the Expedited categories on the U.S. Department of Health and Human Services website. Researchers are also welcome to task the IRB staff with appropriately reviewing their study by making that selection (“I am uncertain, and would like the IRB to categorize my submission”) in Kuali. We will first screen it for exemption, and if it is not exempt, proceed with Expedited or Convened IRB review, as appropriate.
Q) What is the NHSR Determination?
A) “NHSR Determination” means a Non-Human Subjects Research Determination. This is the language that Kuali uses to describe a project does not meet the definition of “research” with a “human subject,” and thus, does not require further IRB review. This is the only official determination that you can receive from USU about whether a project requires substantive (Exempt, Expedited, Convened IRB) review.
Q) How do I respond to IRB comments on my protocol in Kuali?
A) IRB comments come in the form of Action Items in Kuali Protocols. Action Items are review items that require your attention; they are represented by orange indicators adjacent to the field where the review item has been noted by the IRB. Clicking on the Action Item will open the review comment on the right side of your protocol. If the review comment asks for a change in the original field that you agree to make, you must make that change in the field rather than agreeing to it in the Action Item commenting feature. However, if there is disagreement or a need for clarification, please do use the commenting feature. Save your response, and then continue through the protocol until you are ready to hide the Action Item pane and resubmit the protocol!
Q) How can I find out what a particular status means for my protocol?
A) In general, focus on the color of the status dot in your Manage Protocols list: red/orange means that the protocol is with the research team, and blue means it is with the IRB. Unfortunately, there are no distinct statuses to show when a protocol is out with a scientific reviewer versus with the office. You will receive an email from Kuali Notifications when your protocol is placed under review, but there are no notifications available for noting when that review is complete. You are always welcome to check in with us at irb@usu.edu.
You can also review the documentation Kuali provides about its protocol statuses.
Q) How do I amend my Kuali Protocol?
A) Begin by clicking "Amend" on the right side of your protocol. Be sure to fill out the information at the top regarding your amendment, and then continue editing your protocol to reflect the changes you wish to implement. Researchers can add changes directly to the information provided as part of the original protocol when submitting an amendment, there is no need to identify anything as "new" or "amended." Reviewers will be able to see tracked changes, mirroring Microsoft Word’s Track Changes function. Prior versions of the protocol will be saved and available for reference by selecting the version from the dropdown menu at the top of each protocol.
It is critically important that you review your protocol in its entirety when submitting an amendment. Each field that requires an update for your proposed change must be updated; if you do not, our office will deny the amendment so that a more comprehensive one can be submitted. If the proposed changes require updates to your informed consent documents, be sure to work from the version in Admin Notes & Files.
Detailed instructions on filing an amendment to your Kuali Protocol are available here.
Q) How do I renew my Kuali Protocol?
Renewal instructions vary based on whether you have an Exempt, Expedited, Convened IRB, or Reliance Agreement protocol. Instructions specific to your protocol review type are sent to you several times in the 30 days leading up to your protocol's expiration date. Please follow those instructions carefully, or your protocol approval will lapse, and work will need to be paused while a new protocol is reviewed.
Q) The amend/renew/close options are greyed out on my protocol; how can I submit an amendment, renewal, or closure request?
This is likely because another action was started for this protocol, but not submitted. At the top of your protocol, under your protocol title, you can select a protocol version. Click that, and see if there is another In Progress item above it. If so, that pending item is why you cannot submit a new item. If you no longer need that pending item, you can abandon it to submit whatever item you are hoping to submit!
New Kuali Features
Kuali has ceased any new development on Kuali Protocols while it works on its Next Generation offerings, which includes a code base transition for Kuali Protocols. Below are a list of new developments from 2020-2022.
Protocol Duplication
Researchers can now duplicate certain protocols. If the "Duplicate Protocol" option is available, it will be bolded (as opposed to greyed out) on your protocol menu on the right side. If it is greyed out, that option is not available for your protocol.
Notifications about Review Assignments
Kuali released a feature in May 2021 that permits research teams to be notified when an Expedited or Convened IRB protocol has been placed under review with the scientific reviewer. Admin Notes & Files will no longer be updated to inform research teams about assignment dates; instead, these notifications will come straight to your inbox!
Admin Notes & Files
This feature, located on the right side panel for each protocol, houses several important items for each protocol.
- IRB-approved informed consent documents. Your informed consent documents will be emailed directly to you from our office upon approval, but if you need them at a later date, they are located in Admin Notes & Files. It is important that you not use the version you provided in the protocol review process; that version is not the approved version.
- Notations regarding review status. For External Reliance submissions, Admin Notes & Files will give you the most up-to-date status of your protocol. Because Kuali Protocols does not have a status to reflect when the Reliance Agreement has been sent to the other institution for execution, our office will notate those updates in Admin Notes & Files.
- Signed Approval Letters or Exemption Certifications. The official approval or exemption documentation associated with your protocol will be in the Admin Notes & Files section of your protocol once the review is complete.
Research Proposals & Exempt Applications
By asking more targeted and specific questions in the protocol itself, the IRB was able to do away with the requirement to provide a proposal for most exempt projects. In order to meet regulatory and policy requirements, funded projects, dissertation/thesis projects, and certain exemptions requiring “limited IRB review” per 45 CFR 46 still require a proposal. If you are prompted for a proposal in your protocol, you must provide one. The logic in the application is built out not to request one when one is not necessary. If you would like to provide a research proposal anyway, you may do so at the very end of your protocol submission.
Printing/Exporting a Protocol
Kuali allows users to create a printable version of the entire protocol once it has been completed, complete with links to uploaded documents.
Reliance Agreements (aka Institutional Authorization Agreements, or IAAs)
If the other institution does not wish to use SMART IRB for a Reliance Agreement, you will use Kuali Protocols to initiate a Reliance Agreement. From your Manage Protocols page, select “New Protocol” and then “IRB.” Fill in some basic information about the project you are requesting Reliance for, and then select “Reliance on Another IRB’s Review.” Complete the remainder of the form; we will “approve” the Reliance Request once the other IRB has completed the Reliance process with our IRB.
Want to request a feature? Email Kuali Protocols Product Manager Meag Tessmann at meag@kuali.co.
If you would like to test out the Kuali system without creating a "real" protocol, you may do so in the Kuali Sandbox. Access the Kuali Sandbox below.