The Human Research Protection Program (HRPP) has completed the evaluation of Kuali Protocols, and implementation of this new online IRB system has begun.
HRPP is carefully planning to minimize the impact to the research community. This new online IRB system will enhance the user experience. The new system is designed to be user-friendly and we hope that it will make the process of submitting protocols easier, paving the way for a quicker review and turnaround.
What is the new online system?
Kuali Protocols is a cloud based online IRB submission system that will replace KC IRB. The new system will go live January 19, 2021. For important details regarding the timeline, migration of studies in KC IRB, and the one week submission freeze in advance of go-live, see the What do I need to know section below.
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 In Progress.
Phase 4: Testing - Ensure designs and functions meet researcher and regulatory needs. Scheduled for 2020 and In Progress.
Phase 5: Training - Train to ensure a successful transition. Scheduled for December 2020/January 2021 and In Planning.
Phase 6: Submission Freeze - No new submission can be created or submitted for IRB review. Scheduled for January 11 - January 18, 2021 and In Planning.
Go Live! We are here to support you! January 19, 2021.
What do I need to know?
First of all: Don’t panic! The transition from KC IRB (the current system) to Kuali Protocols (the new system) is being closely overseen by the HRPP and should require minimal effort from most study teams. But there are some things you need to know:
IU has been engaged with the Kuali Research software projects for more than a decade. IU functional and technical staff are active members of the Kuali community and represent IU as a client of Kuali to advocate for the features and priorities of our researchers and research compliance offices. Prior to making a final decision to proceed with Kuali Protocols, HRPP leadership considered other available IRB electronic submission systems. A key factor in the decision to implement Kuali Protocols was our ability to impact the development process and advocate for features and functionality that meet our needs. Another advantage of Kuali Protocols is that it is a cloud-based system utilizing continuous delivery.
As an IU researcher, you are likely already familiar with Kuali Research products; you complete your annual COI disclosure using Kuali software (Kuali COI-C), which IU implemented over 3 years ago.
Kuali Protocols is a newer application than KC IRB with a more intuitive interface. However, Kuali Protocols currently lacks some of the functionality we have been able to implement over the years in KC IRB. While certain features may not be available at go-live, HRPP is carefully planning the implementation to minimize the impact of these gaps on researchers. Additionally, Kuali practices continuous delivery of its software which allows new features to be rapidly available without long wait times between releases found in older software. In moving to the cloud for IRB protocols, IU will maintain control of how the system is configured, we can choose to use some features on our own time table, and we do not have to commit resources to months-long upgrade projects.
We hope you’re 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.
Currently in KC IRB, only individuals listed as PI, Co-PI, Aggregator, and Study Manager/Correspondent on a Protocol receive notifications when actions are taken in the system. In Kuali Protocols, these notifications will be sent to all individuals listed on the protocol, including Key Personnel and Non-Key Personnel. As we approach the cutover date, we will provide suggestions and guidance on strategies to manage the influx of notification, including setting up Outlook rules to appropriately filter or flag these notifications.
Currently 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) can view all protocols where their organization is listed as a performance site. In Kuali Protocols, researchers will need to add organization administrators to each protocol as Protocol Viewers. Prompts will be included in the system where possible to remind you to add organization administrators so they can view protocols being conducted at their facility. We are hopeful that this process will only be temporary, as the future plan is to provide individuals in these roles with appropriate system access in a more streamlined manner. For existing studies, we will ensure that appropriate access is granted to organization administrators during the migration process.
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 entirely within the online form, rather than having to download a PDF of the questionnaires to access HSO screener comments.
In Kuali Protocols, 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.
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.
The below image, Pre-review Image 3, illustrates how revisions are displayed when you check the Show Latest Changes checkbox at the top of the submission screen, after responding to an action item. The image displays a sample question with the question ID number, the question text, the action item and edit buttons, but now displays the response text in a tracked changes format. The previous response is shown, to the left, in a red, strikethrough font with a red tag labeled Old. To the right, the edited response is displayed in a green font with a green tag labeled New. This allows you and the screener to see revisions in real time.
Re-Opening a Study after Closure
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. Unfortunately, Kuali Protocols does not have the “copy protocol” function at the current time, so if you wish to resume research activities, you will need to submit a brand new study.
Active studies will be transitioning to Kuali Protocols
We plan to migrate all active Expedited and Full Board studies, and Reliance Requests from KC IRB to Kuali Protocols. For Exempt studies and studies that did not require review (“Not Human Subjects Research” submissions), only those studies that were first approved in 2020 will be transferred.
So what do I need to do?
For many studies, the transition will not require any additional work from the research team. However, there are two situations that may require study team action: studies that are completed but not closed out in KC IRB, and studies that have not received any recent updates such as a renewal or amendment.
Closing completed studies: If you have a study where you have completed all study interventions and no longer need access to identifiable information, please close it. This helps us because we don’t have to transfer unnecessary data; it also helps you because we will not have to ask you for any updates to those studies. (Note: this is NOT the same as closing enrollment to a study. A study should not be closed if you are still performing research activities with individuals or their identifiable data).
For Expedited and Full Board studies, take the “Request to Close” action in the Protocol Actions tab in KC IRB.
Exempt research and Reliance Requests can be closed by simply taking the "Close" action in the Protocol Actions tab in KC IRB.
Updating current studies: In order for a study to be transitioned, it must be on the most recent version of the KC questionnaires. In order to accommodate this, HRPP staff is updating the questionnaires when Amendments and Renewals are submitted. Additionally, we are creating Amendments for some studies to initiate these changes. While most of this can be handled by us, there may be situations where we have to reach out to you for answers to new questions where the information is not already available in the study documents. If you have a study that is still using the old Summary Safeguard Statement (SSS), that information will need to be entered into the questionnaires. Again, HRPP staff will do as much of this as possible, but it is likely that we will need to reach out to you for more information.
What about studies that are not transitioned?
Studies that do not migrate to Kuali Protocols – closed studies and Exempt/Not Human Subjects Research approved prior to 2020 - will be archived and available at request from HRPP staff for three years after the Kuali Protocols system is live.
After the Kuali Protocols go-live date, exempt studies that are not transitioned 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 if you anticipate making changes to your Exempt study.
As described above, all active protocols will be transferred (migrated) into the new Kuali Protocols IRB system. This includes general information associated with the protocol, personnel, questionnaire responses and attachments that are active in KC IRB.
Pending submissions, including New Studies, Amendments, Renewals, and FYI/Reportable Events that are not in an approved status, will not be migrated. Pending submissions include all items with a Status of Pending/In Progress, Submitted to IRB, Return to PI, Provisionally Approved, Tabled, and Withdrawn. These items must be approved prior to the system freeze or they will need to be recreated in Kuali Protocols after January 19, 2021.
For items that are Submitted to IRB, Return to PI, Provisionally Approved, or Tabled, your assigned screener will work closely with you in early January to ensure the item is approved prior to the migration or a plan is created for handling the submission in Kuali Protocols after the go-live date. You can assist us in this process by responding to pre-review and any requests from the IRB as quickly as possible so items can be resolved and approved prior to the data migration.
IRB submissions will not be accepted from January 11, 2021 through January 18, 2021 – the submission freeze period. This one week period is necessary to allow final processing of pending items in KC IRB by HRPP staff and migration of data from KC IRB to Kuali Protocols.
Beginning January 11, 2021, KC IRB will no longer allow creation or submission of new items. HRPP staff will spend the next few days finalizing as many pending submissions as possible. It is vitally important that you respond as quickly as possible to any requests from HRPP staff in the early weeks of January. If you do not respond in a timely fashion, it is possible your pending submission will not be approved and will need to be re-created after January 19th in Kuali Protocols. HRPP staff will provide guidance on the status of any pending submissions and the plan for IRB review prior to the submission freeze or re-creation of the submission after the system cutover.
The new system will feature 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. Our transition team is working hard to make sure the new software is as easy to use as possible. Some improvements include:
Re-writing certain questions that cause confusion on the current forms
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 will be easier, as well.
More information and training opportunities will be provided as we approach the January 19th go-live date. Keep up to date by checking this website regularly. We will also be periodically sending out information via email announcements and newsletters. And of course, if you have questions or concerns, you can email us at email@example.com.
Kuali Protocols training opportunities are coming soon!
Multiple training opportunities will be provided in January 2021. Information regarding training dates and times as well as how to sign up for a training session will be provided in December 2020.
ORC encourages all researchers and research staff to stay subscribed to our Newsletter & Announcements for any compliance updates or changes.
Who to contact?
Contact firstname.lastname@example.org with any questions at this time regarding the implementation.