Instructions to Rely on the State of California’s IRB

1. When is review by the California state Institutional Review Board required?

Review by the California (CA) state Institutional Review Board (IRB), also known as the Committee for the Protection of Human Subjects (CPHS), is required whenever one or more of the following scenarios apply:

  1. UCB investigators want to access personally identifiable data held by the California Health and Human Services Agency (CalHHS) or any of its departments for use in research. Pursuant to the California Information Practices Act (SB 13) (effective January 1, 2006), CA state agencies will only release personally identifiable data to UCB investigators when the request to access the data has been reviewed and approved by the State’s IRB.
  2. UC Berkeley investigators will be engaged in a human subjects research project sponsored by the CalHHS or any of its departments. Research that is funded by one or more of the following departments requires CA state IRB review:
    • California Department of Aging
    • California Department of Child Support Services
    • California Department of Community Services and Development
    • California Department of Developmental Services
    • California Department of Health Care Services
    • California Department of Managed Health Care Services
    • California Department of Public Health
    • California Department of Rehabilitation
    • California Department of Social Services
    • California Department of State Hospitals
    • Emergency Medical Services Authority
    • Department of Health Care Access and Information
    • Office of Youth and Community Restoration
  3. UC Berkeley investigators will be engaged in a collaborative human subjects research project conducted by or under the direction of any employee or agent of the CalHHS or any of its departments.
  4. UC Berkeley investigators will be engaged in a human subjects research project involving participants for whom the CalHHS or any of its departments have direct responsibility, such as patients in CA state hospitals.

Information about the CA state IRB’s legal authority and scope can be found on their website. In addition to the scenarios listed above, there may be other situations in which review by the state IRB is required. Investigators should contact the state IRB administrator at cphs@otsi.ca.gov if they are unsure of whether their project requires review by the CA state IRB.

2. I am a UC Berkeley investigator whose project has been approved by the California state Institutional Review Board. Is this sufficient to start my research?

NO. Review by the CA state IRB does not replace/meet UC Berkeley’s IRB review requirement. UC Berkeley investigators either need to obtain separate UC Berkeley IRB review, or UC Berkeley may rely on the CA state IRB’s review, depending on the following circumstances:

a). When separate UC Berkeley IRB review is required: If the project uses identifiable California state data but does not engage CalHHS or any of its departments in the research, approval is needed from both IRBs:

  • CA state IRB: Reviews the project solely for compliance with the Information Practices Act (IPA), not standard human subjects protection (Common Rule).
  • UC Berkeley IRB: Reviews the project under federal human subjects research regulations (Common Rule).

Investigators must secure approval from both the CA state IRB (for IPA compliance) and UC Berkeley’s IRB (for Common Rule compliance) before accessing or using the data. These reviews may be sought simultaneously.

b). When UC Berkeley may rely on the CA state IRB’s review: When a UC Berkeley research project engages CalHHS (including any of its departments) in human subjects research, UC Berkeley may rely on the CA state IRB for Common Rule review. When a project is eligible for IRB reliance, the process is completed as follows:

Step 1: UC Berkeley investigators obtain IRB approval for Common Rule compliance through the CA state IRB.

Step 2: After approval is obtained, investigators submit a formal request for UC Berkeley to rely on the CA state IRB’s review by sending required documentation to the UC Berkeley Reliance Coordinator at irb_reliance@berkeley.edu:

Step 3: Once paperwork is received and complete, the Reliance Coordinator fills out a CA State CPHS Authorization Agreement (reliance) form for signature by UC Berkeley’s Institutional Official (IO).

Step 4: After receiving the partially signed Authorization Agreement from UC Berkeley’s IO, the UCB Reliance Coordinator submits the form to the CA state IRB for signature as well.

Step 5: The CA state IRB returns the fully executed agreement to the Reliance Coordinator who then notifies the UCB PI/investigators and provides them with a copy of the agreement.

UCB investigators may not commence with any human subjects research activities until the reliance agreement between UC Berkeley and the CA state IRB has been fully executed.

Questions about reliance agreements between UC Berkeley and the CA state IRB should be directed to irb_reliance@berkeley.edu.

Additional Requirements for Accessing Identifiable Data from a CA State Agency:

In addition to the IRB review requirements outlined above, investigators who are requesting to use personally identifiable data (PID) from a CA state agency must consult the Industry Alliances Office’s (IAO’s) Data and Software Agreements for Research page for requirements regarding accessing the PID, such as a data use agreement (DUA) or a data access agreement (DAA). For more information about accessing non-UC Berkeley data, investigators should refer to the FAQ for Secondary Use of Existing Data. In addition, investigators should be aware that as of 2012, the CA state IRB requires a new set of data security requirements for investigators who are requesting PID from CA state agencies. Therefore, investigators wanting to access PID from a CA state agency should contact UC Berkeley’s Information Security Office (ISO) for a California state CPHS data security assessment.

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