Beginning in February 2020, the Institutional Review Board moved to Kuali for all protocol submissions. If you have yet to file a protocol in Kuali Protocols, we recommend that you review the FAQs below to familiarize yourself with some of the differences between it and our old system, Protis. Protis will remain in place until 2023 for protocols that are Active in that system.
Frequently Asked Questions
Q) Why is the IRB switching from Protis to Kuali?
A) Kuali was adopted to increase consistency across Office of Research user interfaces, and because Protis is no longer supported technology. 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.
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) Those protocols must now be submitted in Kuali Protocols.
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 email@example.com.
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 firstname.lastname@example.org 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:
1. 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/or
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) 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. 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. Here are the submission type options:
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. Non Human Subjects Research (NHSR) Determinations have replaced the old Request for Determination (RD) 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 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. You the opportunity to respond to the reviewer comment, edit the original field, or both.
Q) Kuali has very different protocol statuses than Protis does. 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 list and description 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. We are notating that “status” in the Admin Notes & Files section of each individual protocol, but you are always welcome to call or email at any time for an update on your protocol’s status. We have requested that Kuali create a status for this activity, and if you would like to do the same, you can email Kuali’s Protocols Product Managers at email@example.com or firstname.lastname@example.org.
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 details here). Researchers can add changes directly to the information provided as part of the original protocol when submitting an amendment. Reviewers and researchers 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 must 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.
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 all Expedited, Convened IRB, and 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 scientific review has been assigned or completed, 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. Protis had no such functionality.
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.
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.