This Memorandum of Understanding (MOU) applies to all categories of human research, including research that requires full committee review, research that is eligible for expedited review, and research that qualifies for exempt determination. When applicable, the MOU will allow a research study to be reviewed by the IRB at only one UC location, rather than having to go through the entire IRB process at UC Berkeley, UC Davis, UC San Francisco, and/or LBNL.

The MOU became effective in April 2006 and was revised in November 2007. Click on Memorandum of Understanding Between Human Research Protection Programs at UC Berkeley, UC Davis, UC San Francisco, and Lawrence Berkeley National Laboratory [LBNL] to see the MOU in its entirety.

Conditions of Use:

A student, post-doc, or PI from UCB may request that only UC Berkeley, UC Davis, UCSF, or LBNL review his/her application if:

• The research
• will be conducted concurrently at more than one of these UC locations and/or
• involves personal identifiable data or samples from more than one of these UC locations.
• Most or all of the subject contact occurs at one of these UC locations.
• UC Berkeley, UC Davis, UCSF, or LBNL is the prime recipient of the funding award.
• San Francisco Veterans Affairs Medical Center (SFVAMC) is not a site.
• Neither the PI nor any member of the research team has a financial conflict of interest in the project.

Procedures for Use (see Decision Tree):

• PI from the Reviewing Campus Notifies the Reviewing IRB: After the Relying PI completes and signs the Notice of Intent to Rely on Another UC IRB (NOITR), the Reviewing PI submits his/her IRB Application to the Reviewing IRB and includes the completed NOITR.

• The Reviewing IRB Sends a Copy of the NOITR to the Relying IRB.

• The Reviewing and Relying IRBs Determine if Reliance Is Acceptable: The Reviewing IRB has to agree to review. The Relying IRB has to determine if reliance is acceptable. Either or both the Reviewing and the Relying IRB will notify the PI if there is a problem. Otherwise, the PI can assume the reliance is acceptable.

• The Reviewing IRB Notifies PI of Approval: Once the Reviewing IRB has completed its review and granted approval, the Reviewing IRB will send a copy of its IRB approval letter to the Reviewing PI and to the Relying IRB.

• The Relying IRB Issues Letter of Acknowledgment: The Relying IRB will issue a letter of acknowledgment to the Relying PI, the Reviewing IRB, and UCOP. The Relying PI must keep a copy of this letter of acknowledgment in his/her study file in case the study is audited by the home UC Human Research Protection Program, the federal government, or its funding agency.

• Additional Notification Requirements for Reviewing and Relying PIs:  For each continuing review and/or protocol modification, the PIs must file a new Notice of Intent to Rely on Another UC IRB with the Reviewing IRB and any Relying IRB where the research is ongoing.

• Post-Approval Event Reporting for Reviewing and Relying PIs: The PIs should follow the standards and guidelines of the Reviewing IRB for the reporting of any post-approval events. These include adverse events, other safety information, and/or protocol violations or non-compliances.

• Additional Reporting for PIs: The PI at the Reviewing Campus is responsible for notifying the Relying PI, who in turn notifies the Relying IRB, when a study is closed.

Application Instructions:

Reviewing Campus (UCB) Investigator

• Submit normal application documents as required for research protocol (new, continuation, and amendment).
• Include completed NOITR signed by Relying PI.

Relying Campus (UCB) Investigator

• Submit NOITR (original) to Reviewing Campus PI.
• Submit CPHS Application Cover Sheet and CPHS Financial Conflict of Interest Checklist to the Office for Protection of Human Subjects (OPHS).
• Optional: Include a copy of NOITR with the above materials to OPHS.

IMPORTANT NOTE: The application materials must meet all the requirements of the reviewing UC IRB’s standards and guidelines. Links to the websites of these IRBs can be found at UC Office of the President and UC Schools.