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 researchers 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@chhs.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. For all projects where review by the CA state IRB is required, UCB investigators must submit a request for UC Berkeley to rely on the sstate’s IRB review by completing the following supplemental documentation:

  1. Request to rely form
  2. Conflict of Interest checklist

These forms must be signed and dated by the UC Berkeley PI. Once the forms have been completed and signed, they must be sent to a UC Berkeley Reliance Coordinator at irb_reliance@berkeley.edu along with all relevant human subjects training certificates (i.e., UC Berkeley CITI Group 1 or 2; HIPAA and/or GCP if applicable). Information about required education and training can be found on the CPHS education and training page.

The PI/investigators must provide the UC Berkeley Reliance Coordinator with a copy of the CA state IRB approval letter along with the required supplemental documents listed above. UC Berkeley’s Office for Protection of Human Subjects (OPHS) will not process the reliance agreement until after the study has been approved by the CA state IRB.

After the required supplemental documentation is completed and the approval letter is received, the UC Berkeley Reliance Coordinator will fill out a CA State CPHS Authorization Agreement form for signature by UC Berkeley’s Institutional Official (IO). Once signed, the partially executed agreement will be submitted by the UCB Reliance Coordinator to the CA state IRB. When the CA state IRB returns the countersigned and fully executed agreement to the UCB Reliance Coordinator, the Reliance Coordinator will notify the UCB investigators and provide them with a copy of the fully executed reliance 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. Likewise, UCB investigators may not access CA state agency data until the reliance agreement between UC Berkeley and the CA state IRB has been fully executed, and any additional requirements for accessing the data (see below) have been completed.

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 submitting a reliance request as 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 researchers 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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