FREQUENTLY ASKED QUESTIONS RE: IRB FEES
What is the start date for the revised fee schedule?
Effective April 1, 2012, the Human Research Protections unit in the Office of Research will increase the
IRB fee for new IRB applications received on or after April 1, 2012 if they meet the following criteria.
What types of studies will be charged?
Studies that meet the following criteria:
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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
Are there studies that are exempt from charges?
Yes. IRB fees will not be assessed on clinical studies supported by the National Institutes of Health or
other governmental or non-profit entities, on investigator-initiated studies that are not fully or partially
supported by an industry sponsor, or on industry-sponsored studies that do not meet the above criteria.
Will there be a charge for modifications to existing studies?
No.
Will there be a charge for submitting adverse event reports or incident reports?
No.
Will there be a charge for Exempt Certifications?
No.
When will the Lead Researcher be charged?
IRB fees are assessed once the clinical trial agreement is finalized. Fees are collected by recharge to
the account and fund number assigned to the clinical trial. E-mail notification is provided to the
investigator and the department business office regarding the amount and date of each charge.
How are researchers expected to cover the extra costs of these charges?
Researchers should list the expense for IRB review as a budget line item as part of the start-up costs. In
preparing budgets for new clinical trials, researchers should include the amount of the IRB fees to be
incurred during each year of the trial. These fees are in addition to any costs the researcher might want
to include for administrative activities that would be provided by the study team, such as preparation of
the IRB applications and related transactions.
Will all active studies approved by the IRB before April 1, 2012 be charged according to the new review
fee structure?
No, the old fee structure applies to studies submitted to the IRB prior to April 1, 2012.
Example (OLD FEE STRUCTURE): Dr. Scientist submitted a new IRB Application for full committee
IRB review March 31, 2011. The study was approved by the IRB on April 30, 2011. He was charged
$1500.00 based on the old fee structure. On February 1, 2012, Dr. Scientist submitted for continuing
review. His study is re-approved by the IRB on March 1, 2012. He was charged $500.00 based on the
old fee structure. When Dr. Scientist submits for continuing review in 2013, he will again be charged
$500 for continuing review.
Example (NEW FEE STRUCTURE): Dr. Researcher submits a new study for initial full committee IRB
review on April 1, 2012. The study is approved by the IRB on April 26, 2012. She is charged $2200.00
based on the new fee structure. When Dr. Researcher submits for continuing review in 2013 she will be
charged $825.00 based on the new fee structure.
Are there any other cases in which waivers for the charge may be granted?
Generally, no. However, if an investigator believes there are special circumstances, he or she may
request a waiver in writing. Approvals for waivers will be rare and will be approved by the Director of
Research Protections in consultation, as needed, with the Assistant Vice Chancellor for Research.
Are the charges assessed by UCI in line with other institutions?
Yes, the charges are in line with other academic institutions and private IRBs, who commonly charge for
IRB review.
Where do the fees go?
The IRB fee supports the increasing costs of IRB operation. In addition, IRB fees provide benefits to
the research enterprise in the form educational services for researchers, HRP staff, and IRB members
and financial incentives for IRB member participation.
What if I have additional questions?
If you have questions please about the new IRB Fee structure, please contact Karen Allen, Director of
Research Protections at 949-824-1558 or karen.allen@uci.edu.