UC IRB Reliance Registry for Studies under the UC MOU

For assistance with MOU-related issues, please contact irb_reliance@berkeley.edu.

UC Berkeley utilizes the online UC IRB Reliance Registry for studies in which our investigators rely on another UC campus (excluding UC Irvine and UC San Francisco) or Lawrence Berkeley National Lab for IRB review or vice versa by means of the Reliance Memorandum of Understanding and MOU Implementation Procedures.

On this page, researchers will find a summary of the MOU process for reviewing and relying investigators. For more information about the workflow and answers to frequently asked questions, visit the UC IRB Reliance Registry Help page.

Exempt Research Exception

Investigators should note that the following UC campuses* do not enter into reliance agreements for Exempt research:

  • UC Davis
  • UC Irvine
  • UC Los Angeles
  • UC San Diego
  • UC San Francisco

If your study qualifies as Exempt and involves a collaboration with one of the sites listed above, separate applications for Exempt review must be submitted to UC Berkeley and to the collaborating site’s IRB or human subjects protection office.

For all other UC sites, reliance agreements for Exempt research are generally considered on a case-by-case basis. Investigators are strongly encouraged to check in with both UC sites before creating a new reliance request in the online Registry. See Campus IRB Reliance Registry Contacts for contacts for each UC site.

*Subject to change.

Definitions

  • The Reviewing IRB is the IRB that has agreed to review the human subjects research study and assume IRB responsibilities for another UC campus or institution under the MOU.
  • The Reviewing PI is the designated principal investigator (PI) for the research study under the MOU at the UC campus or institution of the Reviewing IRB.
  • The Relying IRB is the IRB that cedes IRB review to a Reviewing IRB for an instance of research under the MOU.
  • The Relying PI is the designated PI for the research study under the MOU at the UC campus or institution of the Relying IRB.

Please review MOU Implementation Procedures for information regarding duties and responsibilities of both Reviewing and Relying IRBs and PIs.

Registration

All first-time users must register with the UC IRB Reliance Registry before they create a new reliance request.

  • Go to UC IRB Reliance Registry.
  • For first-time registration, click “Sign Up” and complete the “User Registration” form. A link to complete the registration will be sent to your email address. Use the link to log in to the Registry and create a new password.

Creating a New Reliance Request

  • If you are the Reviewing PI, click the Create Request tab and check “no” when disclosing if the study involves the Veteran’s Administration (VA) as UC Berkeley will not serve as the IRB of record for VA studies. Complete the information regarding your role in the study and the other required fields marked by an asterisk. Make sure to save your entry every 30 minutes so you are not logged out. Note: If either the reviewing or relying research teams have a conflict of interest, contact the IRB prior to filling out the MOU application.
  • If you are a Student Investigator for the Reviewing or Relying Campus, your faculty sponsor must be listed as the PI. You will have access to the online reliance request (if you list yourself as the Research Coordinator) but only Reviewing PIs may formally submit the application via the Registry.
  • Identify your Relying PIs. You may choose your Relying PI from a list of registered PIs or invite your Relying PI to register and confirm their involvement in the study. Email addresses must be entered accurately as there is no bounce-back function in the system.
  • Once all Reviewing and Relying PIs have signed up for the study via the Registry, the Reviewing PI will be able to convert the registry page to a PDF and submit it with their protocol application to their campus IRB for review.
  • Upon approval of the study, the Reviewing IRB will add the approval/expiration date, approved protocol, approval letter and any applicable consent forms to the study’s Registry record and an automated email notice will be sent to all PIs and the Relying IRB.
    • The Relying IRB will review the documents and accept or deny the reliance via the Registry. UCB requires that our Relying PIs submit the following supplemental materials:

Submitting Renewals and Amendments

Reviewing PIs should submit Continuing Review applications of their studies to their campus IRB, per usual. Upon approval, the Reviewing IRB will update the study’s expiration date in the Registry. No Relying PI can continue work on the study if the Reviewing Campus does not submit a renewal on time.

Amendments must be submitted to the Reviewing IRB who will update any changes to the study in the Registry. The Relying PI is also responsible for informing the Reviewing PI of any necessary amendments.

Reporting Adverse/Unanticipated Events

Reports of adverse and/or unanticipated events must be submitted to the Reviewing IRB who will update any changes to the study in the Registry. The Relying PI is also responsible for informing the Reviewing PI of any adverse/unanticipated events.

For further assistance, please contact irb_reliance@berkeley.edu. Researchers may also call OPHS at (510) 642‑7461.

 

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