Clinical Trials
- The Starting Point
- Confidential Disclosure Agreements (CDA)
- Negotiation and Execution of Clinical Trial Agreements
- Clinical Trial Master Agreements
- Frequently Asked Questions -- Application of Facilities and Administrative (F&A) Cost Rates For Clinical Trials
IRB Fees on Industry Sponsored Clinical Trials
On July 1, 2003, the Office of Research Administration began assessing a fee for the Institutional Review Board (IRB) review related to clinical trials initiated and supported by industry sponsors.
- 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
- Initiated and fully supported by an industry sponsor; and
- Meets UCI contractual requirements for industry-supported clinical trials.
An IRB fee of $1,500 will be assessed upon initial full committee IRB approval when, and if, both parties execute a clinical studies agreement. This fee will be imposed based upon IRB review dates after July 1, regardless of whether the proposed budget included this line item.
An IRB fee of $500 will be assessed at the time of expedited review and approval for all industry-sponsored clinical trials as defined above. This fee will be imposed based upon IRB review dates after July 1, regardless of whether the budget included this line item.
An IRB fee of $500 will be assessed at the time of continuing review and approval for all industry-sponsored clinical trials as defined above. This will apply even to protocols originally approved before July 1, 2003, and regardless of whether the budget included this line item.
No IRB fees will be assessed on clinical studies supported by the National Institutes of Health or other governmental or non-profit entities, on investigator-initiated studies, on industry-sponsored studies that do not meet the above definition of clinical trials, or on clinical trial proposals that are not funded. IRB fees will not be assessed on IRB modifications to approved studies.
In preparing budgets for new clinical trials, investigators should include an amount for the IRB fees to be incurred during each year of the trial. These fees are in addition to any costs the investigator might want to include for administrative activities that would be provided by the study team, such as preparation of the IRB applications, modifications, and adverse event reports.
IRB fees will be assessed as recharges to the account and fund number assigned to the clinical trial and authorized by signature of the Lead Researcher on the IRB application form. E-mail notification will be provided to the investigator and the department business office relative to the amount and date of each charge.
The collected IRB fees provide benefits to the campus research enterprise in the form of enhanced educational services for researchers and financial incentives for IRB member participation. A portion of the fees is returned to the Dean of the School of Medicine to compensate for reduced income to clinical departments resulting from the participation of their faculty on the IRB.
See Section II.b. of the Human Research Protections Program Policies and Procedures.
