Commercial IRBs are independent pay-for-service IRBs that provide regulatory and ethical review services for academic and non-academic institutions to conduct reviews of research involving human subjects. Commercial IRBs will not review research on behalf of UCLA researchers without notification that the UCLA OHRPP has cleared the study for commercial IRB oversight.
Types of studies that qualify for commercial IRB review:
- Clinical trials (all phases)
- Industry sponsored
- Non-industry sponsored, at the discretion of UCLA OHRPP Director
- Others at the discretion of the UCLA OHRPP Director
UCLA has established service agreements with the following commercial IRBs:
Advarra (Chesapeake IRB, Schulman IRB, Advarra IRB)
WIRB-Copernicus Group (Western IRB, Copernicus IRB, New England IRB)
Each commercial IRB has their own submission requirements, which are detailed on their websites. UCLA PIs are required to submit their applications directly to the commercial IRB along with all supporting documents, including the UCLA OHRPP "External Review Accepted" letter.
See below for instructions on how to:
- Obtain a UCLA OHRPP "External Review Accepted" letter for use of commercial IRB service,
- Register the reliance in the UCLA IRB electronic submission system, and
- Communicate with the commercial IRB to obtain IRB approval.
UCLA PI creates and submits a "reliance registration" in the IRB electronic submission system
Applications to applicable ancillary committees (such as CIRC, ISPRC, MRSC, Coverage Analysis, data use agreements, material transfer agreements, etc.) can be submitted in parallel to the IRB reliance registration. UCLA regulatory committee(s)’ required language must be added to the UCLA site-specific consent/assent forms based on the regulatory committee(s)’ request(s).
For more information regarding ancillary review committee requirements, see: Guidance and Procedure: Approvals from Other UCLA and External Committees.
- UCLA OHRPP designated staff screens the reliance registration submission for completeness and will notify the UCLA PI in writing via the IRB electronic submission system for any additional requirements.
- Once the submission is acceptable, the UCLA OHRPP will provide the UCLA PI with the "External Review Accepted" letter attesting that UCLA has agreed to cede IRB review responsibility to the commercial IRB.
- UCLA PI submits the appropriate application, including the "External Review Accepted" letter, to the commercial IRB using their online system.
- The commercial IRB reviews the UCLA PI’s submission and will communicate directly with the UCLA PI with respect to any required revisions and/or additional information as needed.
- UCLA PI will concurrently communicate with UCLA ancillary committees as applicable.
The commercial IRB will communicate directly with the UCLA PI and, when the review is completed, will provide the UCLA PI with an approval notice and stamped versions of the UCLA site-specific consent and recruitment documents (if applicable).