Hello, Kuali

In concert with other Office of Research departments, the Institutional Review Board is moving to Kuali Protocols. The IRB opened Kuali up for user testing and feedback in September of 2019, and has worked to incorporate that feedback wherever possible since that time. At this time, you may file all new protocols in Kuali.

It is highly recommended that you review the FAQs below to familiarize yourself with some of the differences between Protis and Kuali before filing your first protocol in Kuali.

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FAQs for Moving from Protis to Kuali

Q) Why is the IRB switching from Protis to Kuali?

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 Conflict of Interest office are all currently using Kuali.

Q) What is going to happen to my Protis protocols?

A) Protocols that are Active in Protis will remain that way for three years. Most protocols at USU are closed within two years. For those that remain in Protis within the six months leading up to Protis’ expiration, the IRB will be in touch with those PIs regarding a plan to move the projects into Kuali. There is no plan to require those projects to go through another round of review.

Q) What about protocols I’ve already started in Protis?

A) The USU IRB will accept protocols that have already been started in Protis until the last day of the semester – close of business Tuesday, April 21. Effective today, February 18, no new protocols can be created in Protis, but existing ones can be completed and submitted until April 21. (And yes, we know what the last protocol number in Protis is!)

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, and A#s 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 slot is available. You will be able to add the remaining personnel, including making a change to who is serving as 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;
2. obtaining identifiable private information about living individuals for research purposes;
3. obtaining the voluntary informed consent of individuals to be subjects in research; and
4. 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 faculty (or in some cases postdocs) 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.

Q) How does choosing a protocol type differ in Kuali versus Protis?

A) When beginning a new application in Protis, researchers were prompted to answer questions regarding their prospective study, in an effort to match them with an application type. This often resulted in incorrect outcomes. In Kuali, researchers have more 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 will now also be integrated into the submission system.

Q) Which protocol type is appropriate for my research?

A) Description of protocol review types can be found in Chapter 3 of the Investigator Handbook. Researchers are also welcome to task the IRB staff with appropriately reviewing their study by making that selection in Kuali.

Q)What is an NHSR Determination?

A) “NHSR Determination” is the language that Kuali uses to state that a project does not meet the definition of “research” with a “human subject,” and thus, does not require further IRB review. Non Human Subjects Research (NHSR) Determinations are replacing the Request for Determination process in Protis. (And the application is even easier now!)

Q) How do I respond to IRB comments on my protocol in Kuali?

A) The previous “comments” in Protis are now called “Action Items” in Kuali. Action Items are review items that require your attention; they are represented by blue boxes adjacent to the field where the review item has been noted by the IRB. Clicking on the action item gives you the opportunity to respond to the reviewer comment, edit the original field, or both.

Q) Kuali has a lot of protocol statuses. How can I find out what a particular status means for my protocol?

A) Statuses in Kuali differ quite a bit from those used in Protis. An explanation of Kuali statuses can be found here. In general, focus on the color of the status dot: 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 are welcome to call or email at any time for an update on your protocol’s status.

Q) How do I respond to IRB comments on my protocol in Kuali?

A) The previous “comments” in Protis are now called “Action Items” in Kuali. Action Items are review items that require your attention; they are represented by blue boxes adjacent to the field where the review item has been noted by the IRB. Clicking on the action item gives you the opportunity to respond to the reviewer comment, edit the original field, or both.

Q) Have there been changes to the amendment procedures?

A) In Protis, amendments were added in a separate field below information and/or materials provided in the original protocol. This process has been vastly improved in Kuali (get the nitty gritty here). Researchers can add changes directly to the information provided as part of the original protocol when submitting an amendment. 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.

Q) Are research proposals still required for exempt applications?

A) 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.

Q) Can I export a copy of my protocol in Kuali?

A) Kuali allows users to create a printable version of the entire protocol once it has been completed. The functionality currently formats imperfectly, but all content is there. Protis has no export functionality.

Q) What is this Reportable Events tab at the top of my protocol?

A) A Reportable Event is something that occurs during your research project that is not a match with your approved protocol. You can learn more about Reportable Events here. Previously, you would have to report those via a Word doc emailed to the IRB. Now, you can report an event directly from your protocol using the Reportable Events tab.

Q) I was told that my Reliance Agreement (or Institutional Authorization Agreement) request needs to be submitted in Kuali. How do I do that?

A) If the other institution does not use SMART IRB, 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 either “Reliance on Another IRB’s Review,” or “Reliance Agreement for an Active Protis Protocol” (whichever applies). Complete the requested information; we will “approve” the Reliance Request once the other IRB has completed the Reliance process with our IRB. Protocols that are filed in Kuali have the Reliance process built into the overall protocol template now.

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.

Access Kuali Sandbox