UC IRB Reliance

1. Determining if the UCI IRB should be the Relying IRB: Review the Process of Registering New Multi-Site Study Flowchart for an overview of the UC Campuses MOU process. Note: where UCI serves as the IRB of record, UCI will utilize the SMART IRB agreement instead of the UC IRB Reliance.
   1. Relying IRB – The relying IRB is a UC IRB willing to rely on another UC IRB for review and approval of human subjects research.
   2. Reviewing IRB – The reviewing IRB is one of the following:
      • The UC location which is the prime recipient of the research award, or
      • In studies where the research is not funded by an external award, the campus with which the Principal Investigator (PI) or Lead Researcher (LR) is primarily affiliated.

      NOTE: Exceptions to this provision shall be determined by the Institutional Official at the UC location that is the prime recipient of the research award or the campus with which the PI is primarily affiliated.

2. Notifying the UCI IRB The Reviewing Campus PI notifies all Relying IRBs (including UCI) of the intent to submit a protocol under the UC Campuses MOU by creating a request at the UC IRB Reliance Registry
3. Acknowledging Participation as a Relying PI: After the Reviewing Campus PI submits the Reliance Request, an invitation will be sent to all Relying PIs to log into the registry and acknowledge their participation as a Relying PI for the newly registered study.  For step-by-step instructions on how to register on the UC IRB Reliance Registry, please use this guidance document. Please note that only after all invited PIs register their participation will the Reviewing PI be able to sign the Request Form and submit the Registry Request (previously the NOITR process).
4. UC IRB Reliance Registry Approval: After the Reviewing IRB reviews the study and agrees to serve as the Reviewing IRB, they will enter the approval and upload the IRB Approval Letter into the UC IRB Reliance Registry. The Registry will notify all Relying IRBs that the study has been approved.
5. Submitting to the UCI IRB for Administrative Registration: Once the Reviewing IRB approves the study via the UC IRB Reliance Registry, the UCI investigator must register the study with the UCI IRB. The UCI investigator submits a new application online.  See How to Submit Protocols to the UCI IRB for details.
6. Reviewing the Reliance Request and IRB Approved Study Documents: The UCI IRB will determine if reliance upon another UC campus for IRB review is acceptable. The UCI IRB may refuse, on a case-by-case basis to rely on the IRB review of another UC location. Further, any other required regulatory committee approvals must be in place before the UCI IRB will agree to rely and research can commence at UCI. This includes, but is not limited to the, Protocol Review and Monitoring Committee (PRMC), Conflict of Interest Oversight Committee (COIOC), Radiation Safety Committee (RSC), and others as required.
7. IRB Reliance Letter: The Reviewing IRB will upload a IRB Reliance Letter to the Registry which will notify all parties that the reliance is completed. The registration (approval) period will coincide with the Reviewing IRB approval and expiration date. The UCI investigators must keep a copy of the reliance letter and approval documents for their records.
8. UCI Investigator Responsibilities to Reviewing IRB: The UCI investigator must comply with all decisions of the Reviewing IRB. This includes following the standards and guidelines of the Reviewing IRB for the reporting of any adverse events, other safety information, and/or protocol violations or incidents.
9. UCI Investigator Responsibilities to the UCI IRB: The UCI investigator is responsible for advising the UCI IRB of the continuation of the approved study by submitting copies of such materials to the Office of Research and for the reporting of any adverse events, other safety information, and/or protocol violations or incidents.

Once the Reviewing IRB approves the continuation of the study, the UCI investigator must submit a request for continuing administrative registration. Please see the following flowchart for a description of the process.

1. Notifying the UCI IRB: The Reviewing Investigator submits a request through the UC IRB Reliance Registry for continuation of the protocol.
2. Reviewing IRB Responsibilities: Upon approval of the continuing protocol application, the Reviewing Campus IRB will update the UC IRB Reliance Registry with the updated approval dates along with the updated approval documents.
3. Submitting to the UCI IRB for Continuing Administrative Registration: After the UCI investigator receives notification from the UC IRB Reliance Registry that the protocol has been re-approved, the UCI investigator must submit a copy of the IRB Approval Letter to IRBReliance@uci.edu.
4. IRB Reliance Letter: The Reviewing IRB will upload a IRB Reliance Letter to the Registry which will notify all parties that the reliance is completed. The registration (approval) period will coincide with the Reviewing IRB approval and expiration date. The UCI investigators must keep a copy of the reliance letter and approval documents for their records.
5. UCI Investigator Responsibilities to Reviewing IRB: The UCI investigator must comply with all decisions of the Reviewing IRB. This includes following the standards and guidelines of the Reviewing IRB for the reporting of any adverse events, other safety information, and/or protocol violations or incidents.
6. UCI Investigator Responsibilities to the UCI IRB: The UCI investigator is responsible for advising the UCI IRB of the continuation of the approved study by submitting the e-CPA to the UCI IRB.

Review the Process of Registering Amendments/Adverse Events/Unanticipated Problems Flowchart for an overview of the UC Campuses MOU process.

Modifications:

All changes (e.g., a change in procedure, number of subjects, personnel, study locations, new recruitment materials, study instruments, etc.) must be prospectively reviewed and approved by the UC reviewing campus IRB before they are implemented.  The UCI Investigator must notify the UCI IRB of any modification requests that involve significant changes via the online MOD request form. A significant modification/change is a change in research related activities that significantly affects an assessment of the risks and benefits of the study or substantially changes the specific aims or design of the study.  See the list of examples of minor vs. significant changes for more information.

Adverse Events/Unanticipated Problems:

The UCI investigator must report all reportable adverse events and unanticipated problems to the UCI IRB. For more information on what constitutes a reportable event, see the list of reportable events. The UCI IRB will review any incident(s) and notify the Reviewing IRB as applicable (i.e., constitutes a reportable event – unanticipated problem involving risk to subjects or others).