• Brief Overview
• Definitions and Responsibilities
• Information & Instructions: Exempt and Expedited IRB Review for Collaborative Research under MOU at All UC Campuses and LBNL
• Information & Instructions: All Categories of IRB Review for Collaborative Research under MOU at UC Berkeley, UC Davis, UC San Francisco, and LBNL

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

The 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 confirm, where appropriate, that the application or proposal for human subjects research submitted to the federal Department of Health and Human Services (HHS) is consistent with 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.

The 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 comes aware.
  
  
• The Relying IRB will send the Principal 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.
  

Steps for Use

Use above links to obtain more information, instructions, and forms for each of the two UC Memoranda of Understanding agreements: 1) the MOU between all UC campuses and LBNL for expedited and exempt categories of human research, and 2) the MOU between UC Berkeley, UC Davis, UC San Francisco, and LBNL for all categories of human research. If you have any questions in this regard, you may call or email the OPHS Analyst of the Day (see OPHS contact information).