FAQ

Find answers to some of the questions we've been hearing below, organized by topic.

Kuali IRB Access

Who has access to view, edit and upload to the IRB application?

An administrative contact may be provided 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.

Can you still have co-investigators within Kuali?

Yes, Kuali IRB allows you to add co-investigators as part of study personnel.

Is there a limit to who can have access?

Kuali IRB does not have a limit on the number of users who can access records.

Will individuals have the ability to route draft versions of IRB submissions to the PI for final review before official submission?

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.

Who will be able to submit applications to the IRB Office for review?

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.

Any internal department processes required to submit applications should be completed prior to submission.

Does the PI-only submission apply to Continuing Reviews as well?

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.

How will non-UCSD user accounts be handled with Kuali IRB?

The project team and UC San Diego IT Services have developed a process for non-UC San Diego users. Details can be found in Submitting Access Request for Kuali IRB Process - Non-UCSD Users.

Will the legacy eIRB System be accessible once Kuali IRB has gone live?

The legacy system will still be accessible for project transfers until July 2022.

When will the legacy system no longer be available?

July 2022

Is it possible to get access to what others have uploaded to the legacy eIRB system so I can see all of files related to our studies before the system turns into an archive?

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.

Documents

Is there a means to batch download documents from the existing IRB system?

Not at this time.

Various security measures adopted over the years prevent this, but we are actively looking into options to make this work.

Will there be a way for relying sites to have access to downloading their sIRB stamped consent documents? Or will it still be up to us as the coordinator of a single IRB to distribute those?

The UC San Diego coordinating unit will need to distribute study documents to sites relying on UC San Diego IRB.

Do the ICFs have all documents listed that have been submitted and approved?

We haven't configured the text of approval letters yet but will look for opportunities to populate this information.

Can Kuali be used for activities other than soft research project document creation? (i.e., approval forms for internal departmental records.)

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.

See more about Kuali Build.

Submit a Kuali Build New Application Request at UC San Diego.

Business Processes

Do we submit amendment requests to existing protocols in/around June before the protocol gets rolled over to KIRB via e-IRB?

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 no longer be available after July 2022.

Should we roll studies with a status of 'Analysis Only' to the new system or keep it in the legacy system?

Depending on what activities remain, you may be able to close IRB oversight of the study now.

If you can't close IRB oversight now but you expect to close it by July 2022, you will not roll it over.
If it needs continued IRB oversight past June 2022, you will transition it to Kuali IRB at Continuing Review.

Find details on the Study Matrix Kuali IRB Transition.

Will we still be required to submit stamped/clean consents for continuing review?

No, submission of stamped/clean consents will not be required in Kuali IRB.

Will Analysis Only switch to review every 3 years?

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).

If you can't close IRB oversight now but you expect to close it by July 2022, you will not roll it over.
If it needs continued IRB oversight past June 2022, you will transition it to Kuali IRB at Continuing Review.

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.

Find details on the Study Matrix Kuali IRB Transition.

Will Kuali IRB include Approval-In-Principal guidance and applications?

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 have used the 'Notice of Intent to Rely' for some of our large-scale surveys (e.g., all new students, all graduating seniors, etc.) with the UCLA IRB. Will the NOITR process remain in place or be changed?

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.

How will use of single /central commercial IRB (e.g. Advarra) be addressed in Kuali IRB?

Kuali IRB has a streamlined pathway for studies that are being registered for reliance on an outside IRB, including commercial IRBs.

Will SMART IRB also roll over to Kuali?

Kuali IRB has a streamlined pathway for studies that are being registered for reliance on an outside IRB, including under the SMART IRB agreement.

Do you anticipate a need to revisit the exemption process for large-scale undergraduate and graduate surveys primarily used for program review, or should we now resubmit our survey research for IRB review?

An application will confirm that the activity does not qualify as Human Subjects Research (HSR).

If you previously secured a non-HSR determination for these surveys, additional confirmation is not required.
If the activities or intent of these activities changes, we recommended you seek confirmation again.

When does renewal of an existing HRPP project come into effect?

When existing projects become due for Continuing Review 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.

Integrations

Has consideration been given to implementation at RCHSD? Are there interface issues that need to be considered to provide the same functionality at RCHSD as at UC San Diego?

Yes, the project team is collaborating with IT Services and with the RCHSD research leadership to provide similar functionality.

Will there be integration between HRPP and PRMC?

Currently there is no planned integration between IRB and PRMC.

Will this system be integrated with OCTA / OCAA to streamline final release of stamped ICF?

We're still working out the process integrations for executing grants and contracts.

Does Kuali have the ability to communicate to other offices (OCTA/OCGA, Business office)? For example, ensuring study flows to the correct office (OGCA/OCTA, unfunded etc.)?

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.

Will Kuali IRB have the ability to integrate with CTMS platforms?

No, we do not plan to integrate with CTMS platforms at this time.

Testing & Training

Is training provided?

Yes, visit Get Ready for Kuali IRB to view recorded training sessions.

With medical studies terminology and logic used in IRB forms, will social sciences users be asked to test the new system?

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.