Find answers to some of the questions we've been hearing below, organized by topic.
You may provide an administrative contact with access to initiate and prepare an application. The PI and/or application preparer control which members of the study and related personnel will have read-only or editing access.
The entire history (including documents such as approved consent forms) will be accessible to all designated people.
Yes, Kuali IRB will allow you to add co-investigators as part of study personnel.
Kuali IRB does not have a limit on the number of users who can access records.
Yes, the Study Personnel can prepare the application and upload documents then notify the PI that the application, to the best of their knowledge, is available for them to review.
The application preparer will need to answer the “User Assurance/Acknowledgement” section prior to submitting an application to the review staff.
The system currently allows users on a protocol application with “Full Access” permission to submit the application to the review staff. The submitter will need to answer the “User Assurance/Acknowledgement” section prior to submitting an application to the review staff. The PI and Study Team are notified that the application is submitted. Should the need arise, the PI or Study Team can contact the Office of IRB administration to request the application be returned if needed.
Any internal department processes required to submit applications should be completed prior to submission.
No, system configuration was updated after multiple rounds of testing to allow users listed on a protocol application with “Full Access” permission to submit a Continuing Review application. The submitter will need to answer the “User Assurance/Acknowledgement” section prior to submitting an application to the review staff.
The project team and UC San Diego IT Services have developed a process for non-UC San Diego users here: <link to KBA about Access Request Process>
The legacy system will still be accessible after Kuali IRB is live. Some actions will still be taken in that system until approximately July 2022.
July 2022
The current system was set up with the PI of the study to access all documents in the project file. It is recommended to follow up with the PI to obtain this information.
The project team is currently investigating options to this process and will announce updates in future communications.
Not at this time.
Various security measures adopted over the years prevents this, but we are actively looking into options to make this work.
The UC San Diego coordinating unit will need to distribute study documents to sites relying on UC San Diego IRB.
We haven't configured the text of approval letters yet but will look for opportunities to populate this information.
Separate from Kuali IRB, UC San Diego is deploying Kuali Build. A Kuali Build Application consists of a smart form, approval and notification workflow and document dashboard, and is available to build department/process-specific documentation.
Submit a Kuali Build New Application Request at UC San Diego.
Yes, the current system will be operational for amendments to an existing study until that study either closes or is transitioned to Kuali IRB at Continuing Review, whichever happens first.
The current system will not be available after July 2022.
Depending on what activities remain, you may be able to close IRB oversight of the study now (we'll be releasing guidance about this soon).
No, submission of stamped/clean consents will not be required in Kuali IRB.
Depending on what activities remain, you may be able to close IRB oversight of the study now (we'll be releasing guidance about this soon).
Because of changes to regulations, we're phasing out the 3-year approval periods and we may be able to covert them to no renewals needed. We will update you when this is determined.
Kuali IRB will include a Delayed Onset application.
This is a compliant version of the former "Approval-in-Principle," but only for use in limited circumstances (mostly proposals funded by the National Science Foundation).
We'll also better serve you with other administrative determinations such as confirmations that research is not regulated (because, for example, you're not involving "human subjects" or your activities are not "research" as defined in the regulations).
We haven't worked out the exact impact on the NOITR and the UC Reliance Registry, but Kuali IRB will have a streamlined pathway for studies that are being registered for reliance on an outside IRB.
Kuali IRB will have a streamlined pathway for studies that are being registered for reliance on an outside IRB, including commercial IRBs.
Kuali IRB will have a streamlined pathway for studies that are being registered for reliance on an outside IRB, including under the SMART IRB agreement.
An application will confirm that the activity does not qualify as Human Subjects Research (HSR).
When existing projects become due for Continuing Review (starting with IRB approvals that expire around August 2021) there is a rollover process to follow. The conversion and Continuing Review will be done in Kuali, and all transactions for a study will be conducted in Kuali after conversion.
Yes, the project team is collaborating with IT Services and with the RCHSD research leadership to provide similar functionality.
Currently there is no planned integration between IRB and PRMC.
We're still working out the process integrations for executing grants and contracts.
Kuali IRB will include some functionality to notify other units (COI, HERC, IBC, OCGA/OCTA, OCAA) when an IRB submission has been submitted to the IRB that involves their unit. We plan to improve this functionality over time.
No, we do not plan to integrate with CTMS platforms at this time.
Yes, guidelines will be made available before the system goes live.
Yes, training will be provided before and after the system goes live.
Visit the Get Ready for Kuali IRB page for current information and available courses.
Contact us at esr-irb@ucsd.edu, and we will include you in our communication and scheduling of upcoming sessions.
We have designed Kuali IRB to include risk-proportionate reviews for social science protocols and avoid the biomedical framework.
Our testing and feedback process will include representatives from the social/behavioral/educational research community along with designated IRB members.
We will provide instructions and training to guide users for risk-proportionate review and how to avoid unnecessary IRB reviews.