UCI ADMINISTRATIVE POLICIES & PROCEDURES
RESEARCH AND SPONSORED ACTIVITIES
Human Subjects Research
Section 485-2: IRB Review Fee Recharge Program
Responsible Office: Office of Research Administration
Issued: July 1, 2003
Revised: March 17, 2008
Revised: March 1, 2012
Summary:
On July 1, 2003, the Office of Research began assessing a fee for the Institutional Review Board (IRB) review related to clinical trials initiated and supported by industry sponsors. Exempted from the fees are studies wholly funded by: public entities, such as Federally sponsored studies; cooperative group trials; private non-profit entities; gifts to the University; or internal sources. In 2008, this policy was revised to exempt from payment of the review fee, full committee protocols that have closed to enrollment and completed interventions or that are open solely for data analysis. Effective April 1, 2012 IRB fees increased for new studies submitted for IRB review and approval.
Background
Institutional Review Boards (IRBs) and their human subject protection programs are highly regulated operations requiring experienced researchers, highly skilled staff, and dedicated community and non-scientific representatives. All institutions performing human research with federal funding must comply with two sets of federal regulations (45 CFR 46, governing research supported by any federal agency, and 21 CFR 50 and 56, governing research on products regulated by the Food and Drug Administration). The Department of Health and Human Services' Office for Human Research Protections (OHRP) and the Food and Drug Administration provide oversight of institutional human research protection programs. UCI accepts federal funding and, thus, falls under the terms of these regulations.
The IRB fee supports the increasing costs of IRB operation and research oversight not otherwise covered by the overhead assessment.
Amount of Fee
The IRB review fee schedule is shown below. The fee level is consistent with rates at other university medical centers. The rates will be reviewed annually and adjustments made as necessary. Additional F&A costs are assessed on the IRB review fee.
Effective April 1, 2012, the Human Research Protections unit in the Office of Research will increase the IRB fee for those IRB applications that meet the following criteria and are received on or after April 1, 2012:
- 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.
The new fee structure is as follows:
Initial Review - Full Committee / $ 2200.00Initial Review - Expedited / $ 1000.00
Continuing Review - Full Committee / $ 825.00
Continuing Review - Expedited / $ 500.00
Continuing Review 7-Year De Novo - Full Committee / $ 1500.00
Continuing Review 7-Year De Novo - Expedited / $ 725.00
IRB applications received prior to April 1, 2012 are charged according to the old criteria and at the old rate, as follows:
Initial Review - Full Committee / $ 1500.00Initial Review - Expedited / $ 500.00
Continuing Review - Full Committee, including 7-Year De Novo / $ 500.00
Continuing Review – Expedited, including 7-Year De Novo / $ 500.00
IRB fees are not assessed on IRB modifications/amendments to approved studies or exempt studies.
In preparing budgets for new clinical trials, investigators 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 investigator 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.
IRB fees are 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 is provided to the investigator and the department business office regarding 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 are transferred to the IRB Member’s department, as a stipend.
Payment of the fee will not provide additional services (e.g., preferential review or faster response time), nor guarantee the outcome of the review.
Implementation
A predetermined fee is assessed for IRB review of studies fully or partially supported by for-profit, commercial entities. For-profit sponsors routinely allow such a fee in their budgets. Studies that are fully internally funded or supported by non-profit entities are exempted from the IRB review fees. At this time, federally supported studies and NCI-sponsored cooperative group trials are not assessed a review charge since the expense is considered part of Facilities and Administrative (indirect) costs rate.
Processing of the Fee
In order to reduce the administrative burden on investigators and staff, ORA Sponsored Projects and IRB staff notes the anticipated funding source in the ORA databases and track the execution of the agreement with a for-profit sponsor. When the contract is finalized and the IRB approval is issued, Office of Research Operations electronically issues an Interdepartmental Recharge Invoice to the appropriate account/fund. Questions regarding the appropriateness of the charge should be directed to the Director of Research Protections or the Director for Sponsored Projects.
The Director of Research Protections retains the right to waive or reduce the fee when justified under special circumstances. Such waiver requests must be made in writing and signed by the Lead Researcher. Any approved waiver does not establish a precedent for other actions unless the policy is amended.
Appeals may be directed to the Assistant Vice Chancellor for Research.