Relying on Another IRB for Review via Memorandum of Understanding (MOU)

Brief Overview

The purpose of this guidance is to help UC Berkeley investigators determine in which cases they may rely on another UC IRB (Institutional Review Board) to review their human research projects. Current UCB policy requires that all faculty, staff, and students (as applicable) must have approval from UCB’s IRB, the CPHS (Committee for Protection of Human Subjects) before they begin research using human subjects. This requirement applies regardless of the source of funding and even when no funds are involved, and regardless of the site of the study activities. However, there are several exceptions, which are described below.

The following limited exceptions have been made in response to requests by investigators for a more streamlined IRB review for research studies involving multiple UC campuses.

Definitions and Responsibilities

Reviewing IRB

  • The Reviewing IRB will conduct initial and continuing reviews, and will review amendments to an approved protocol and all unanticipated problems or adverse events that may arise.
  • The Reviewing IRB will have the authority to suspend the research for failure to comply with conditions of approval or regulatory requirements.
  • The Reviewing IRB will notify the Relying IRB(s) of any adverse events, unanticipated problems, or suspension of research.
  • The Reviewing IRB will consider conflicts of interest and confirm, where appropriate, that the application or proposal for human subjects research submitted to the federal Department of Health and Human Services (HHS) matches the protocol submitted for IRB approval.
  • The Reviewing IRB will serve as the IRB of record.
  • A UC IRB may refuse, on a case-by-case basis, to serve as the IRB of record for another UC location.

Relying IRB

  • The Relying IRB will rely on the IRB review of the Reviewing IRB. It will not re-review the study. However, an institution may impose institution-specific requirements on its investigators. For example, a Relying IRB may have different human subjects education or training requirements than the Reviewing IRB UC institution. In this case, investigators at the relying campus must adhere to local HRPP policies and procedures for education and training.
  • The Relying IRB’s Human Research Protection Program (HRPP) will monitor compliance with the terms and conditions of the Reviewing IRB’s approval or research being conducted at the relying UC location. The Relying IRB will advise the Reviewing IRB of any noncompliance of which it becomes aware.
  • The Relying IRB will send the Lead Investigator and the Reviewing IRB a letter acknowledging receipt of each exempt determination or IRB approval.
  • A UC IRB may refuse, on a case-by-case basis, to rely on the review of another UC IRB.

Memorandum of Understanding (MOU) Between Human Research Protection Programs at University of California Campuses and UC-Managed Laboratories for IRB Review of Multi-Campus Human Subject Research for Exempt and Expedited Categories of Research

This Memorandum of Understanding (MOU) applies to research eligible for expedited review research involving no more than minimal risk to the subject, as well as research that qualifies for exempt status review. When applicable, the MOU will allow research to be reviewed by the IRB at only one UC location rather than having to go through the entire IRB process at every UC campus at which the research will take place.

The MOU became effective March 21, 2006. Click on Memorandum of Understanding Between Human Research Protection Programs at University of California Campuses and UC-Managed Laboratories for IRB Review of Multi-Campus Human Subject Research to see the MOU in its entirety.

Conditions of Use:

A Lead Investigator (LI) from UC Berkeley may request that another UC IRB review his or her application if:

1) The research is not regulated by the FDA; and,

2) Any of the following conditions are met:

  • The research:
    • will be conducted concurrently at more than one UC location and/or
    • involves personal identifiable data or samples from more than one UC location.
  • Most or all of the subject contact occurs at another site.
  • Another UC campus is the prime recipient of the funding award.
  • Research has already been approved at one UC campus or lab and the investigator transfers to another campus.

Steps for Use:

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