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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.

In an effort to promote a more streamlined process, effective in 2020, where UCI serves as the IRB of record, UCI will utilize the SMART IRB agreement instead of the UC IRB Reliance.  SMART IRB is a platform designed to ease common challenges associated with initiating multisite research.  Important note: SMART IRB is not an actual IRB that provides regulatory approval. SMART IRB provides a roadmap for institutions to implement the Single IRB Review requirements. Through a flexible master IRB reliance agreement, standard operating procedures, and complementary tools and resources, SMART IRB supports and encourages collaboration and harmonization across the nation.

SMART IRB is funded by the National Center for Advancing Translational Sciences (NCATS). For more information, visit SMART IRB.

When UCI is relying, 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. 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. 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. 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.

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. 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.

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 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). 

Flowcharts

UC IRB Reliance Process

(Note: In an effort to promote a more streamlined process, effective in 2020, where UCI serves as the IRB of record, UCI will utilize the SMART IRB agreement instead of the UC IRB Reliance.)

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