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UC IRB Reliance

Terms of the UC IRB Reliance

All UC campuses and Lawrence Berkeley National Laboratory have signed a Memorandum of Understanding (MOU) that allows one UC IRB to rely on another UC IRB for review and approval of human subjects research. The UC MOU allows human subjects research to be reviewed by one UC IRB rather than submitting for IRB approval at each UC campus where the research will take place. A UCI investigator may request that another UC IRB review his or her application if:

The research:

  • will be a collaborative or multi-site effort involving two or more UC locations;
  • involves obtaining individually identifiable data or samples from two or more UC campuses, on which one or more other UC campuses will conduct analyses; and/or
  • Involves obtaining biospecimens for research subject to FDA regulations.

Also:

  • Another UC location is the prime recipient of the funding award, or
  • UCI acts solely as the funding recipient of an award however no research activities will be taking place at UCI, or
  • The Principal Investigator (PI) of the study is affiliated with another UC location, or
  • The research will primarily take place at another UC location (e.g., subject contact occurs at one UC location), and
  • No UCI research team member has a disclosable financial interest that would require review by the UCI Conflict of Interest Oversight Committee (COIOC). 

UCI uses the online UC IRB Reliance Registry for all studies requesting IRB review under the UC MOU. All new reliance requests, renewals and modifications will need to be submitted via the online registry.  Instructions on how to register and work with the new UC IRB Reliance Registry are available here.

Relying on another UC Campus IRB for Review and Approval

A UCI investigator may request to rely on another UC IRB if the study meets the terms of the UC Campuses MOU.  For step-by-step instructions on how to register on the UC IRB Reliance Registry, please use this guidance. For detailed instructions on this process, see below as well as the following instructions for: Relying Campus PI or Research Coordinator

Procedures for New Applications:

  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.
    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. Click here for instructions on using the UC IRB Reliance Registry. 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. UCI IRB Reliance Letter: The UCI IRB will upload a UCI Reliance Letter to the Registry which will notify all parties that the reliance is completed at UCI. 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.

Procedures for Continuing Protocol Applications:

Once the Reviewing IRB approves the continuation of the study, the UCI investigator must submit a request for continuing administrative registration. Please click here to 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. UCI IRB Reliance Letter: The UCI IRB will upload a UCI IRB Reliance Letter to the Registry. The registration period will coincide with the Reviewing IRB approval and expiration date. The UCI investigators must keep a copy of the registration 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.

Procedures for Modifications and Adverse Events/Unanticipated Problems:

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 e-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 via the online e-AE/UP form. 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). 

UCI Serving as the UC Reviewing IRB for another UC Campus IRB

UCI may serve as the Reviewing IRB of record for other UC campuses that wish to rely on UCI if the study meets the terms of the UC Campuses MOU. For more information on this process, see below as well as the following instructions for: Reviewing Campus PI or Research Coordinator

Procedures for New Applications:

  1. Determining if the UCI IRB should be the Reviewing IRB: Review the Process of Registering New Multi-Site Study Flowchart for an overview of the UC Campuses MOU process.
    1. Reviewing IRB – UCI should be the reviewing IRB if one of the following applies:
      1. UCI is the prime recipient of the research award, or
      2. In studies where the research is not funded by an external award, the Principal Investigator (PI) is primarily affiliated with UCI.
      NOTES:
      • For UCI to serve as the Reviewing IRB, the UCI investigator must be willing to serve as the Lead Researcher (LR) and accept responsibility for the conduct of the study at the other UC campus sites.
      • 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. Relying IRB – The relying IRB is a participating UC location that does not meet the criteria for the Reviewing IRB.
  2. Notifying the UCI IRB & Relying IRB: The UCI investigator notifies the UCI IRB and the Relying IRB of the intent to submit a protocol under the UC Campuses MOU by creating a request at the UC IRB Reliance Registry
  3. Submitting the UCI IRB for Protocol Approval: The UCI investigator completes the online UCI IRB Application (eAPP) for UCI IRB review and approval. See How to Submit Protocols to the UCI IRB for details. When entering the title of the study, please add, “(UC Reliance)” at the beginning of the study title. NOTES:
    • The UCI protocol narrative must describe all activities that will occur at each UC campus and include all study investigators engaged in the research at all other UC locations that are relying on the UCI IRB for review.
    • Under the UC Campuses MOU, UCI becomes a Coordinating Center for a UC Multi-campus Study. Please be sure to complete Appendix A when filling out the IRB application and indicate that this study is being submitted under the UC Campuses MOU.
    • All investigators from other UC campuses must comply with the human research protections education requirements for their own institution. Campus education requirements will be verified by each investigator’s campus IRB prior to agreeing to rely.
  4. Reviewing the UC IRB Reliance Request: The UCI IRB will determine if it will serve as the Reviewing IRB of record for other UC campuses. The UCI IRB may refuse, on a case-by-case basis, to be the Reviewing IRB for the research. Also, the Relying IRB must agree to rely on the UCI IRB review and it must agree that UCI will serve as the IRB of record for the study. A campus or lab may refuse, on a case-by-case basis to rely on UCI  IRB for review. The UCI IRB and/or the Relying IRB will notify the UCI investigator by e-mail or phone if there is a problem.
  5. Notification of UCI IRB approval: The UCI IRB will upload an IRB approval letter and the approved study documents to the UC IRB Reliance Registry which will notify all Relying Campus Investigators, Relying IRB Directors, and UCOP of the Reliance approval.
  6. UCI Investigator Responsibilities to UC Relying Campuses: The UCI investigator is responsible for submitting for timely submission of any modifications and adverse events and/or unanticipated problems (AE/UPs) as well as submitting for continuing approval to the UCI IRB.
  7. UC Relying Campus Investigator Responsibilities: Relying Investigators are required to promptly inform the UCI PI of any need for modifications to the study.  Adverse events and unanticipated problems may need to be first reported to an investigator’s local IRB for consideration. If investigators have questions about their reporting responsibilities they should contact their local IRB for assistance.

Procedures for Continuing Protocol Applications

  1. Submitting to the UCI IRB for Continuing Approval: The UCI investigator must submit an electronic Continuing Protocol Application (eCPA) to the UCI IRB in a timely manner.
  2. Notifying the UCI IRB & Relying IRB: The UCI investigator notifies the UCI IRB and the Relying IRB of the intent to submit a continuing protocol under the UC Campuses MOU through the UC IRB Reliance Registry. Please see the flowchart describing the process for submitting for Continuing Review via the registry here.
  3. Notification of UCI IRB approval: The UCI IRB uploads the new IRB approval letter and any approved study documents to the UCI investigator which will notify all Relying Campus Investigators, Relying IRB Directors, and UCOP of the continuing approval of the Reliance Request.
  4. UC Relying Campus Investigator Responsibilities: Investigators should contact their IRB for details on the acknowledgment process for their campus.

Procedures for Modifications and Adverse Events/Unanticipated Problems:

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

Modifications

  1. 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 UCI IRB via the online e-MOD request form before they are implemented.
  2. Notification of UCI IRB approval: The UCI IRB will upload an IRB e-MOD approval letter and the approved study documents to the UC IRB Reliance Registry which will notify all Relying Campus Investigators, Relying IRB Directors, and UCOP of the Reliance approval.

Adverse Events/Unanticipated Problems:

The UCI investigator must report all reportable adverse events and unanticipated problems to the UCI IRB via the online e-AE/UP form. 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 all Relying Campus Investigators, Relying IRB Directors via the UC IRB Reliance Registry as applicable (i.e., constitutes a reportable event – unanticipated problem involving risk to subjects or others).

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