ZOT IRB + Safety (hSCRO)

Limited IRB Submissions

In order to transition effectively, limited protocol submissions will begin on August 4, 2025 and run through September 14, 2025. This will allow additional time for HRP to clear their review queue, train on the new system and, importantly, the data migration process.

Exceptions may be made based on how closely the application meets the below criteria.  Researchers who qualify will submit through the current process in KRP.  To obtain the passcode needed for submission, contact Beverley Alberola or Jessica Sheldon in HRP AFTER August 1, 2025.

The following table illustrates what submissions will and will not be allowed:

 

Data Migration

Only IRB and hSCRO approved protocols will migrate. Un-submitted drafts will be discarded.  Not yet approved applications will be discarded. If a protocol is currently under IRB review, work closely with the HRP and the IRB to finalize and approve the application prior to the launch and final data migration – prior to September 15, 2025.

In order to transition to Huron IRB, the HRP must migrate current data in KRP.

Here is what will migrate:

• IRB approved protocols
• IRB approved protocol attachments (latest versions only)
• A PDF of the entire IRB approved protocol
• Important!! Please note that unsubmitted drafts and submitted items in KRP that remain unapproved by the IRB by August 4, 2025 will be discarded.

When a researcher’s protocol migrates from KRP to the Huron IRB SmartForm, not all data fields will be a perfect match. The Huron IRB SmartForm is condensed.  Only essential study information will be housed in the Huron IRB SmartForm. Information will include; basic study information (e.g., title of study, description, IRB of record, study team, conflict of interest, department or lead unit, Principal Investigator (PI) eligibility and submission type), study funding, study scope (e.g., drug, supplement, device (i.e., if a medical device and under clinical investigation)), study procedures, study site (e.g., UCI campus, UCI Health), and study related attachments (e.g., consent forms, recruitment materials and other attachments as noted above).

UCI HRP will maintain complete data from KRP through a combination of self-service Cognos reports and FileNet. Researchers must maintain their own complete IRB protocol records as a part of their PI responsibilites.

Protocol Narratives:

The Huron IRB SmartForm contains basic information. Details will reside in a Word document or Protocol Narrative, similar to what was used prior to KRP. This attachment is to be uploaded into the Huron IRB system as a part of the IRB protocol submission.

Once Huron IRB launches, at the next transaction, researchers will need to complete any errant or incomplete fields within the Huron IRB SmartForm and, if any protocol changes are proposed, append a completed Protocol Narrative as part of an amendment application. Researchers can get started by completing the Protocol Narrative in advance.   Below are the Draft Protocol Narrative templates. 

 We expect to post final versions of the following by early August 2025. 

• Biomedical Full Committee
• Exempt / Expedited / Full Committee Social Behavioral Educational
• Exempt Self Determination
• Non Human Subject Self Determination
• UCI is Relying IRB
• hSCRO Protocol Narrative