IRB Fees

The Human Research Protections unit in the Office of Research will charge Institutional Review Board (IRB) fees for new clinical research submissions that are partially or fully supported by industry sponsors, including chart review studies. 

Applicability

IRB Review Fees apply to all clinical research involving human subjects that are funded in whole (including chart review studies) or in part by industry sponsors.  If UCI defers review to an independent IRB (e.g., Western IRB, Advarra), UCI IRB charges the one-time fee of $1,800 for administrative review and oversight. 

 IRB Review Fees are not charged for the following:

• Exempt research;
• Modifications/ amendments to approved studies;
• Unanticipated Problems

For additional information on what qualifies as “clinical research” for the purpose of IRB Fees, please see HRPP Policy# 6 and/ or the UCI IRB Review Fee Policy.

HRPP Policy # 6 states (in part):

The UCI IRB will assess a charge for all fully or partially industry-supported IRB submissions requiring initial and continuing review that meet the following criteria:

• Designed to assess the safety, efficacy, benefits, adverse reactions, and/or other outcomes of drugs, devices, diagnostics, treatments, procedures, medical evaluations, monitoring or preventive measures; and
• Fully or partially supported by an industry sponsor; and
• Meets UCI contractual requirements for industry-supported clinical trials.
• All initial study submissions to the UCI IRB must identify the funding sources supporting the proposed research.

Note: When an IRB submission is received and is not designated as fully or partially industry-supported, but is later determined by the IRB to be industry-supported, appropriate IRB fees will be assessed.

Researchers need to account for applicable IRB Review Fees in their proposed budgets for industry-sponsored projects, as well as budgets for all subcontracts they expect to receive from such industry sponsors.

IRB Review Fee Collections Process

IRB fees are assessed once the research is approved by the IRB.  If the agreement / contract is finalized, the fees will be recharged to the study account. For recharges, e-mail notification is provided to the investigator and the department business office regarding the amount and date of each charge. 

Effective July 1, 2020, the single IRB (sIRB) process will have a new fee structure that reflects the HRP service level when submitting the study to a non-UCI IRB. 

There will be two tiers.  The Self-Service model allows the research team to submit to the non-UCI IRB.

In the Full-Service model, the UCI sIRB Team will administer the submission.

⦁    The sIRB fee for Full-Service remains at $1800.00.
⦁    The sIRB fee for Self-Service will be $975.00.

When requesting that UCI rely on another non-UCI IRB, please be sure to:

1.        Complete a UCI IRB Application,
2.        In Section 6 of the UCI IRB Application, indicate that UCI will rely on another non-UCI IRB.  Next, select either “Self-Service” or “Full-Service.”
3.        In addition, be sure to complete and submit Appendix R.

Submitting the UCI IRB Application enables the HRP sIRB team to perform the required local ancillary clearance process (e.g., Conflict of Interest, Radiation Safety Review, etc.).  This review applies to both tiers and must occur prior before submission to the non-UCI IRB.

Contacts

If you have questions about the new IRB Fee structure contact Beverley Alberola, Director of Human Researh Protections at 949-824-5746 or beverley.alberola@uci.edu.