The UC Memorandum of Understanding (MOU) outlines the agreement between and among the Human Research Protection Programs at the ten campuses of the University of California and the Lawrence Berkeley National Laboratory. The MOU describes the criteria and procedures for the relience by a Human Research Protection Program (HRPP) at a UC campus or at the Berkeley Lab on the review and approval, or determination of exemption, of human subject research, by a HRPP at another UC campus or Berkeley Lab.

The types of research covered by this agreement include human subject research as defined by federal and state statutes and regulations that is determined to be exempt or is eligible for IRB review and that:

1. will be a collaborative research effort between one or more of the UC campuses or Berkely Lab
2. involves obtaining individually identifiable data or samples from one or more UC campuses or Berkeley Lab on which one or more other UC campuses or Berkeley Lab will conduct analyses
3. involves obtaining samples that are not identifiable for research subject to oversight by the Food and Drug Administration (FDA)

Note: Starting July 1, 2012, UC investigators applying for a new or renewed reliance on another UC campus or Berkeley Laboratory for IRB review or vice versa by means of the UC MOU will be required to do so using the UC Online Reliance Registry at http://irbreliance.ucop.edu . Paper NOITRs will no longer be processed after that date.

Help with using the Registry can be found at https://irbreliance.ucop.edu/site/help .

A summary of the instructions includes the following:

If you are the Reviewing Campus Principal Investigator (PI) or Research Coordinator (RC), Request a New Reliance:

1. If you have not already Request a New Reliance, register by going to http://irbreliance.ucop.edu and click on "Register" and complete the "User Registration" form.
2. Click Create Request tab You will need to disclose if your study involves the VA. (The UC IRB MOU applies only to UC campuses and the Lawrence Berkeley National Laboratory.)
3. Identify your role in the study. Be prepared to answer all of the questions marked with the red asterisk. You can complete the form in a few sessions if you make sure you save each of your entries.
4. Enter contact information for the Relying Campus PIs. The Registry will send each PI an e-mail invitation to register and sign up for the study. Once all of the invited PIs have registered their participation, you will be able to sign the Request form. The Office of the President notes:

   "Prior to signing this form, you may want to check with the [UCSD HRPP] if all entered information is correct, and make appropriate changes BEFORE signing the assurances at the bottom of the form. At this time, the IRB Reliance Registry does not allow for editing after you declare that the information entered is correct by signing off on the form."

5. Sign the Request form
6. Convert it to a PDF
7. Submit it along with a complete initial review submission, including...
   1. Application Facesheets
   2. Research Plan
   3. Consent documents (as appropriate)
   4. Instructions for submitting a new project can be found in the IRB How To section.
8. Once the UCSD IRB approves your study, the UCSD HRPP will enter the study's approval expiration date in the Registry as well as upload the approved Research Plan and consent form, if applicable. You will receive an e-mail from the Registry informing you that these procedures have been done and you will be able to review all of the uploaded documents for any study you are associated with in the Registry.

Continuing Review, Submitting Amendment and Reporting Adverse and Unanticipated Events

1. You will submit to the UCSD IRB/HRPP required documents for Continuing Review approximately 45 days prior to expiration date of the study.
   • Continuing Review Documents are found on the Forms page .
   Once the Continuing Review has been approved, the UCSD HRPP will update the expiration date in the Registry. The Office of the President notes: "... no relying UC site on your study will be able to continue work if you don't obtain IRB renewal [continuing review approval] on time: it is your responsibility as a Reviewing Campus PI to apply for the renewal [continuing review] on time!"
2. You are responsible for submitting amendments, adverse events and unanticipated problem(s) involving risk to subject or others to the UCSD IRB/HRPP per UCSD IRB/HRPP guidelines — regardless of whether they are related to the UCSD site or to a Relying Campus. The Relying PIs/RCs are required to promptly inform you of all such events and you will submit those to the UCSD HRPP per guidelines, not using the Registry. Results of the review of these submissions will be provided to you and uploaded into the Registry by the UCSD HRPP.

If You are a Relying Campus PI or RC on a Study using the Registry

If you have received an e-mail invitation from the Registry noting that you have been identified as a PI or RC on a multisite study on a Relying campus.

1. Follow the instructions provided in the e-mail.
2. Be prepared to answer all of the questions marked with the red asterisk.You can complete the form in a few sessions if you make sure you save each of your entries.
3. Register your participation as soon as possible. Only after all of the invited Relying PIs have registered their participation can the Reviewing PI sign the Request form, which is needed as part of the submission to the Reviewing IRB. A delay in responding to the e-mail invitation to register your participation will further delay the IRB review. Note: although the UCSD IRB/HRPP will likely accept to rely on the Reviewing Campus IRB, this does not constitute funding or other institutional required approvals. It is the investigator's responsibility to ensure all approvals are in place prior to conducting the research.
4. Once the Reviewing campus IRB approves the study, they will enter the study's approval expiration date in the Registry as well as upload the approved Research Plan and consent form, if applicable. You and the UCSD IRB/HRPP will receive an e-mail from the Registry informing you and UCSD of the Relying Campus IRB approval. The UCSD IRB/HRPP will then review all of the uploaded documents and decide whether to accept or deny to rely on the Reviewing Campus IRB review. If the UCSD IRB/HRPP decides to accept to rely, we will upload an acceptance letter to the Registry and the reliance will be complete.

Continuing Review, Submitting Amendment and Reporting Adverse and Unanticipated Events

1. You are required to promptly inform the Reviewing PI/RC of the need for amendments. You are also required to report to the Reviewing PI/RC and the UCSD HRPP any adverse or unanticipated events at the UCSD site. The Reviewing PI is responsible for notifying the Reviewing Campus IRB following the Reviewing Campus's guidelines and using the Registry. Any decision, change in protocol, etc. will be reported and uploaded to the Registry by the Reviewing Campus IRB.
2. Continuing Reviews (Annual Reviews) are the responsibilty of the Reviewing PI. If the Continuing Review approval is not obtained in a timely manner, none of the relying sites will be allowed to continue research. The Relying IRB will update the Registry once the Continuing Review approval has been granted.

For more information, please contact the HRPP Office at 858-246-HRPP (858-246-4777) .