New Kuali Protocols Launch

Kuali Protocols, the new online IRB system, is here!

This page will be updated periodically to add additional information about using Kuali Protocols and to answer frequently asked questions. Check back regularly for the latest information as you begin using the new system.

 

What is the new online system?

Kuali Protocols is a cloud based online IRB submission system that replaced KC IRB.  The new system is now live.

Kuali Protocols training opportunities

Training on Kuali Protocols is being conducted remotely due to the pandemic, but a variety of options are available. 

If you would like to request a small group training session, please complete the request form and we will be in touch to confirm scheduling.

What do I need to know?

CITI training is not properly loading for some protocols. 

  • For studies migrated from KC IRB (identified by a 9 or 10 digit study number), all personnel will initially appear in Kuali Protocols with a blue bar in the training section of the personnel table noting that there are no training courses on file. This information may not be accurate. Action is required to refresh CITI training information on migrated studies. HRPP staff will trigger updates as part of our review process when needed. If you prefer, you can trigger these updates with an Amendment submission by selecting Personnel as a section to be edited, and clicking the pencil icon next to each Person’s name to trigger CITI training to update. Once CITI training has been updated in the system one time, it will automatically update going forward.

Active studies were migrated to Kuali Protocols

All active (approved) Expedited and Full Board studies, and Reliance Requests in KC IRB were migrated to Kuali Protocols.

For Exempt studies and Not Human Subjects Research submissions, only those approved in 2020 were migrated.

What about studies that were not migrated?

Studies that were not migrated to Kuali Protocols - closed studies and Exempt/Not Human Subjects Research approved prior to 2020 - can still be viewed in KC IRB which now allows read-only access for researchers.  Read-only access to KC IRB will be maintained for at least three years after the January 2021 Kuali Protocols implementation date.

Exempt studies that were not migrated cannot be amended in Kuali Protocols. If an Amendment is required to a pre-2020 exempt study, a new exempt submission will be required in Kuali Protocols.

Please note that most Exempt research never requires any additional submission to the IRB. Therefore, the need to update these studies will be rare. Please refer to our guidance or contact irb@iu.edu if you are unsure if your Exempt research requires an Amendment.

As described above, all active protocols were migrated into the new Kuali Protocols IRB system. This includes general information associated with the protocol, personnel, questionnaire responses and attachments.

Pending submissions, including New Studies, Amendments, Renewals, and FYI/Reportable Events that were not in an approved status as of January 13, 2021, were not migrated. Pending submissions include all items with a Status of Pending/In Progress, Submitted to IRB, Return to PI, Provisionally Approved, Tabled, and Withdrawn.

The new system features an improved user interface and an improved pre-review process, among other changes.  Improvements to the logic in the new software have given us some opportunities to avoid confusion and redundancy in the questionnaire.  Some improvements include:

  • Re-writing certain questions that caused confusion in KC IRB
  • Whenever possible, avoiding the need to ask duplicate questions, or multiple questions that require the same information in response
  • Reducing the need to copy/paste information from existing documents (like an Informed Consent Statement or Protocol) into the online form
  • Improving the integration of multiple research sites and non-affiliated investigators

Amending and renewing studies in Kuali Protocols is easier, as well.

Yes, the current integration between KC IRB and OnCore will be duplicated for Kuali Protocols.  IU developers are actively working on the integration, and we expect the integration to be available within the coming months.  Submissions approved in Kuali Protocols prior to the OnCore integration roll out will need to be manually entered into OnCore. IU HRPP staff will be manually entering this information on your behalf, but there may be a lag between approval and the manual entry of this information in OnCore.

Because Microsoft no longer actively supports Internet Explorer, users may experience difficulties accessing Kuali Protocols using Internet Explorer.  For the best experience, we recommend using one of the following browsers: Google Chrome, Firefox, MS Edge, or Safari.   If you currently use Internet Explorer as your default browser, please contact your IT support professional to get access to one of the recommended browsers.

Differences between KC IRB and Kuali Protocols

We hope you are as excited about our new IRB submission system, Kuali Protocols, as we are! We want to make you aware of some differences that may affect your procedures and processes. If you would like more information on any of these changes, please contact us at irb@iu.edu.

In KC IRB, all users were able to view a limited set of information for all protocols in the KC IRB system. Specifically, the protocols that displayed on the search results screen in KC IRB were not filtered in any way – any user could search for any protocol and it would display in their search results. However, whether the user could open the protocol in KC IRB to view full information was limited by various levels of system permissions.

In Kuali Protocols, users are restricted, even in their initial search results, to  view only those protocols to which they either have read-only or full access, either as a Unit (department) Viewer, or as an individual listed as Research Personnel or on the Permissions tab. If you have a business need to view protocols that you are unable to access in Kuali Protocols, please contact us at irb@iu.edu and we can explore options for access.

Several changes have been made related to study personnel, including new required documentation, a change in terminology, the elimination of special processes for non-key personnel updates, and a shift in responsibility for ensuring CITI training is complete for certain personnel. These changes are described in further detail below:

  • New required documentation

The PI’s curriculum vitae (CV) must be provided as a personnel attachment with new study submissions for Expedited/Full Board studies and Requests to Rely. This is required with each new study submission even when the PI’s CV has already been provided with a prior submission.

  • Change in terminology

Personnel who have previously been classified as “non-key personnel” in KC IRB are now referred to as “Other Research Staff” in Kuali Protocols. No changes are being made to Key Personnel. As a reminder, individuals who are responsible for the design, conduct, or reporting of the research, including individuals who make critical decisions regarding eligibility of subjects, individuals obtaining consent for greater than minimal risk research, and individuals listed on FDA Form 1572, are considered key personnel. Individuals not falling into these categories should be listed as Other Research Staff in Kuali Protocols.

  • Elimination of non-key personnel updates

All personnel updates, including key personnel updates and other research personnel updates, are considered Amendments in Kuali Protocols. Effective January 19, 2021, prospective IRB review and approval of personnel updates is required unless the research is Exempt and only IU-affiliated individuals are being added. In other words, if you need to add an individual as Other Research Staff on an Expedited/Full Board or Request to Rely, you must submit an Amendment in Kuali Protocols and await IRB/HRPP review and approval before that individual can begin interacting with subjects and/or viewing identifiable subject data.

  • IRB verification of CITI training

We will no longer collect information in Kuali Protocols regarding whether Other Research Staff are interacting with subjects. For Other Research Staff, CITI training is only required if the individual is interacting with subjects. Because this information will no longer be collected in the IRB application form, the HRPP will no longer verify CITI training completion for Other Research Staff. The PI, or their designee, is required to ensure CITI training is complete and up to date for all Other Research Staff interacting with subjects for their study. Documentation of CITI completion for these personnel should be maintained in your research records. CITI completion information will be visible in Kuali Protocols, or IU staff can use the CITI lookup tool. To access this look-up tool, you should be signed into Pulse before logging in.

  • Non-research personnel permissions

Just like in KC IRB, individuals who are not research personnel can have access to the IRB Protocol record in Kuali Protocols.  Similar to KC IRB, these individuals are listed on the Permissions tab in Kuali Protocols.  Individuals on the Permissions tab do not need to be assigned a role (e.g., Aggregator or Study Manager).  Instead, only the level of permissions, Full Access or Read-Only, is assigned.

In KC IRB, only individuals listed as PI, Co-PI, Aggregator, or Study Manager/Correspondent on a Protocol received notifications when actions were taken in the system.

In Kuali Protocols, the following framework is used for notifications:

  • Submit notification – sent to PI and IRB office only
    • To confirm your item is submitted, check the Version list at the top of the Protocol screen or the Status on the Manage Protocols screen
  • All other notifications, including pre-review notifications, approval notifications, and renewal reminders, are sent to all individuals listed on the protocol, even those with non-IU email addresses
    • This includes all individuals listed as PI, co-PI, Site-Specific PI, Key Personnel, Other Research Staff, and all individuals listed on the Permissions tab.

We are hopeful that the broad sending of certain notifications to all personnel will be temporary, as the future plan is to limit personnel who receive notifications.

In KC IRB, administrators at various hospitals and organizations that rely on the IU IRB to review and approve research conducted at their facilities (organization administrators) were able to view all protocols for which their organization was listed as a performance site.

In Kuali Protocols, researchers need to add organization administrators to the Permissions tab on each protocol. Prompts are included in the form to remind you to add organization administrators so they can view protocols being conducted at their facility. We are hopeful that this process will be temporary, as the future plan is to provide individuals in these roles with appropriate system access in a more streamlined manner.

Kuali Protocols does not automatically assign submission numbers to Amendments, Renewals, and Reportable Events. For both Amendments and Reportable Events, the individual creating the submission will assign an item number, using the A0XX or F0XX format.

For migrated studies originally approved in KC IRB, this identifier should continue the numbering from KC IRB. For example, if Amendments A001 through A004 were previously approved in KC IRB, the first Amendment in Kuali Protocols should be numbered A005. This identifier is included on the Approval letter generated by Kuali Protocols to allow easy identification of the item to which the Approval letter applies.

Renewals no longer have an assigned item identifier in Kuali Protocols. Renewals are easily identified by the month and year of submission and approval. Therefore, manually maintaining identifiers for Renewals is not necessary.

In KC IRB, users were instructed to always create Renewals as Renewals with Amendment regardless of whether they needed to make changes to the approved study documents or information with the Renewal.

In Kuali Protocols, this is not required. You should only take the Renew/Amend action if you need to make changes to the IRB Protocol. If no changes are necessary, you should take the Renew action. You will be able to upload Renewal attachments, such as DSMB reports and deviation logs directly in the Renewal form without the need for an Amendment in the system.

Say ‘Goodbye’ to hunting for and downloading pre-review in KC IRB; say ‘Hello’ to easily accessible and visible pre-review comments within Kuali Protocols! Kuali Protocols allows for the pre-review process to be conducted within the online form, rather than having to download a PDF of the questionnaires to access HRPP screener comments.  (Pre-review comments on documents such as the Informed Consent will still need to be downloaded for viewing. However, these documents are easily accessible on the same page as the online form.)

When revisions are requested by a screener, an Action Item will appear directly in the online form outlining questions and requested revisions. Action items appear either next to specific questions or as General Action Items.

The below image, Pre-review Image 1, illustrates how an action item is displayed when a response and/or revisions are requested in pre-review. The image shows a sample question which displays question ID number, the question text, and the researcher's response text. Aligned to the right of the question, a blue button displays, noting 1 Action Item needs response. Directly below the action item button, is an Edit button enabling inline revisions.

Pre-review Image 1Pre-review Image 1

 

The below image, Pre-review Image 2, illustrates the dialogue box displayed when the blue Action Item button is selected. Your screen will expand to include a view of the action items dialogue box to the right. The image shows a ribbon at the top of the dialogue box displaying the question ID number and an arrow to the right that closes the action item dialogue box. Below the ribbon, each action item displays who posted the item, the date and time it was posted, along with the detailed action item comments.  Below the item comments, a summary of who can view the item is shown, as well as any previous action item response posts.  If the item is not resolved, a Reply link is provided to respond to the action item. You are then able to edit your response inline on the form and/or directly respond to the screener in the action item dialogue box.

Pre-review Image 2Pre-review Image 2

Informed consent documents are no longer watermarked by Kuali Protocols. Additionally, the approved consent will no longer be uploaded as a PDF document. Instead, the final, approved consent will be a Word document that can be downloaded from the attachments section in Kuali Protocols. To ensure the correct version of the consent is being used, the HRPP now requires the use of version dates in the header or footer of informed consents. While the HRPP does not dictate a system or method for version dating, they will ensure that the date or number is updated with any submission that includes a change to the text of the Informed Consent Statement.

Kuali Protocols will be validated as Part 11 compliant. Therefore, ink signatures are no longer applied to a Protocol Summary Report to indicate approval of studies. Instead, the IRB reviewer or a designated HRPP staff member takes the approval action directly in Kuali Protocols and an Approval Letter is generated for the submission.

Additionally, the Kuali Protocols Approval Letter does not support the inclusion of all of the categories of information that were previously included on the KC IRB Approval Letter. Specifically, the list of study personnel and list of sites are not included on the Approval Letter. Additionally, the IRB's determinations are not included with the exception of studies requiring waivers of HIPAA authorization.

All study-specific information that may be needed and is not displayed on the Approval Letter can be found directly in Kuali Protocols.

Finally, certain types of actions in Kuali Protocols, including Not Human Subjects Research determinations, do not generate a formal Approval Letter. For these items, only an email notification is generated. Where this is the case, the email notification includes language indicating that a separate Approval Letter will not be generated and the email notification should be saved in your research records.

After a closeout report is completed (approved) in Kuali Protocols, the protocol cannot be reopened. Please ensure that all research activities, including analysis of identifiable data, is complete before closing a study in Kuali Protocols. Kuali Protocols does not have the “copy protocol” function at the current time or the ability to re-open a closed study, so if you wish to resume research activities, you will need to submit a new study.

Implementation Timeline

Graphic representation of Kuali Protocols Implementation Timeline

Information represented in the above 'Implementation Timeline' graphic:

Phase 1: Discovery - Establish project goals, conduct gap assessment, and discover solutions. Scheduled for 2019 and Complete.
Phase 2: Design - Creation of the forms, reports, and process re-design. Scheduled for 2020 and Complete.
Phase 3: Data Conversion - Conduct iterative analysis and conversion of active studies. Scheduled for 2020 and Complete.
Phase 4: Testing - Ensure designs and functions meet researcher and regulatory needs. Scheduled for 2020 and Complete.
Phase 5: Training - Train to ensure a successful transition. Scheduled for January 2021 and In Progress.
Phase 6: Submission Freeze - No new submission can be created or submitted for IRB review. Scheduled for January 11 - January 18, 2021 and Complete.
We are here to support you! Go Live! January 19, 2021.

Who to contact?

Contact irb@iu.edu with any questions at this time regarding the implementation.

ORC encourages all researchers and research staff to stay subscribed to our Newsletter & Announcements for any compliance updates or changes.