Change in IRB Fees Effective July 1, 2019

Change in IRB Fees Effective July 1, 2019

Background

The Human Research Protections unit in the Office of Research charges Institutional Review Board (IRB) fees for reviewing new and continuing clinical research submissions that are partially or fully supported by industry sponsors, including chart review studies.  The last increase in IRB fees occurred in 2012. 

The number and complexity of human research protocols at UCI have increased since that time, particularly as it relates to the single IRB/ reliance review process.  In addition, because these services are provided on a re-charge basis and revenue has not kept pace with expenditures, a portion of the increase will reduce the current deficit.

To adapt for the current climate and anticipated growth of our program, the UCI Recharge Rate Review Committee has approved an increase in IRB fees effective July 1, 2019. For a detailed table of IRB fees, see Table 1 below.

We understand that these fee increases may cause challenges for some studies.  In such case, please contact Beverley Alberola at 949-824-5746 or . Going forward, the Office of Research is committed to reviewing and revising these fees on a more frequent basis – at least once per year to ensure minimum fluctuations in future rate changes.

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.

Human Subjects Research Budgets

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. 

Contacts

If you have questions about the new IRB Fee structure contact Beverley Alberola, Interim Director of IRB Operations at 949-824-5746 or . 

Table 1.