UCLA OHRPP Policy
IRB review fees are charged for industry-sponsored clinical trials as new clinical trial agreements are negotiated. A onetime fee of $3,200 will be charged for the review of new industry-sponsored clinical trials that meet the following conditions:
- Designed to assess in humans the safety, efficacy, benefits, adverse reactions, and/or other outcomes of drugs, devices, diagnostics, treatments, procedures, medical evaluations, monitoring or preventive measures; and
- Fully supported by an industry sponsor; and
- Comply with UC Operating Requirement 95-5 "Requirements for Administration of Agreements with Private Sponsors for Drug and Device Testing Using Human Subjects."
As of September 1, 2023, there will be a new fee of $2000 charged for any industry-sponsored clinical trial that utilizes a reliance mechanism for the IRB review and approval.
The number and complexity of human research protocols at the University of California, Los Angeles (UCLA) have increased substantially in recent years. Each of these studies requires review and ongoing oversight by the Institutional Review Board (IRB)/Office of Human Research Protection Program (OHRPP) a process that is vital to the university’s ability to conduct research. The fee structure for industry-funded research is being updated to help meet current needs and allow revenue to keep pace with expenditures.
Rates for Recharge of IRB Reviews
The following rates are effective September 1, 2023.
|For Industry-Sponsored Clinical Trials|
|Initial Full/Expedited Committee Review||$3,200|
|Initial Reliance Review||$2,000|
Important Note: There is no charge for exempt research, amendments, continuing reviews, or post approval reports (PARs) submitted to the UCLA-OHRPP for review and processing. For additional information please review the Frequently Asked Questions below.
IRB review fees are also not charged for unfunded research, clinical studies supported by the National Institutes of Health (NIH) or other government agencies, investigator-initiated studies, or industry-sponsored studies that do not meet the UCLA definition of a clinical trial outlined above.
FAQs about the UCLA-OHRPP Charge for Review
The following questions are the most common ones that have been asked about the recharge for UCLA-OHRPP review for industry-sponsored studies.
When does the increase in IRB review fees take effect?
The new rates for UCLA IRB review and Reliance Reviews applies to all new contracts submitted on or after September 1, 2023.
When and how will these fees be paid?
The IRB fee is to be budgeted as a separate line item in the contract budget and reimbursed by the sponsor at the time of contract execution. The invoicing and collection of the fee will be managed by the Office of Research Administration with assistance from the School of Medicine Clinical Trial Administration Office.
How do investigators cover the costs of these charges?
Investigators should list the expense for IRB review as a budget line item as part of the start-up costs. IRB fees ($3200 for initial UCLA IRB review and $2000 for Reliance review) should be included in clinical trial budgets. However, since the fees are not subject to F&A charges, they should be listed as a separate line item, and not included in the F&A calculation.
Will there be a charge for modifications of existing studies?
No, there will be no charge for continuing renewals, amendments, or modifications.
Will there be a charge for submitting post approval reports?
No, there will be no charge for that action.
Will there be a charge for Exempt Certifications?
No, there will be no charge for exempt certifications.
Who do I contact if I have questions?
If you have questions about the collection of the IRB fee, please contact Marcia Smith, Associate Vice Chancellor in the Office of Research Administration. For questions about budgeting or negotiating the fee with industry sponsors, please contact Tamika Merrick, Director of Clinical Trials Contracts & Strategic Relations (CTC&SR).