Instructions to Rely on the State of California’s IRB
1. Collaborative Research Involving a CA State Agency:
Whenever UC Berkeley investigators will be involved in a collaborative research project with a California (CA) state agency, and UC Berkeley will be engaged in the proposed human subjects research, the project must be reviewed and approved by the state of California’s Institutional Review Board (IRB). Note that review by the CA state IRB does not replace/meet UC Berkeley’s IRB review requirement. For collaborative projects involving the state of CA, UCB investigators must submit a request for UC Berkeley to rely on the state’s IRB review by completing the following supplemental documentation:
(i). Request to rely form
(ii). 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 CPHS/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.
Questions about reliance agreements between UC Berkeley and the CA state IRB should be directed to irb_reliance@berkeley.edu.
2. Accessing Identifiable Data from a CA State Agency:
UCB investigators may want to access personally identifiable data from a CA state agency for use in research. Investigators should know that 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 of California’s institutional review board (IRB). Note that review by the CA state IRB does not replace/meet UC Berkeley’s IRB review requirement. And, in accordance with SB 13, the State IRB will not rely on another institution (i.e., UC Berkeley) for review of research involving personally identifiable CA state data. In order to access personally identifiable data from a CA state agency, UCB investigators must submit a request for UC Berkeley to rely on the state’s IRB review by completing the following supplemental documentation:
(i). Request to rely form
(ii). 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 CPHS/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 access the 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.