The number and complexity of human research protocols at the University of California, Davis (UC Davis) have increased substantially in recent years. Each of these studies requires review and ongoing oversight by the Institutional Review Board (IRB), a process that is vital to the university’s ability to conduct research.
In 1999, following the practice in place at most peer institutions around the country, UC Davis implemented application of an IRB Review Fee for review of industry-sponsored clinical research (including clinical trials). Prior to that time, all of the cost of overseeing industry-sponsored research at UC Davis was fully subsidized by the F&A (“indirects”) funds received from the federally funded grants, as well as by state funds received by the University.
While the fee structure for industry funded research is now being updated to help meet current needs, please note that University continues to heavily subsidize this activity.
We have received approval from the Office of Resource Management and Planning to proceed as follows:
Effective October 1, 2009, in order to streamline the process of application of IRB Review Fee detailed below, UC Davis is implementing the following changes to its IRB Review Fee program:
- IRB Review Fees will be collected based on the following rates for all industry sponsored projects, regardless of the committee reviewing them:
- Initial Review: $3,400
- Each Annual Review: $1,600
The above listed IRB Review Fees apply to all research involving human subjects, fully, or in part funded by extramural funds, and conducted by UC Davis employees, students, or agents, except for those projects that are fully and directly funded by the following sources:
Additionally, the following IRB reviews will not be assessed IRB Review Fee:
- Reporting adverse events;
- Annual review of investigator-initiated clinical trials (however these projects continue to be subject to IRB Review Fee for their initial review);
- Review of modifications and amendments of previously IRB approved projects;
- Projects that qualify as “Exempt Review”, as defined by the Code of Federal Regulations, Title 45, Part 46, Section 101(b)(1) through 101(b)(6) §46.101(b)(1) through (6),- (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm/l46.101(b)(1)#46.101(b)(1));
- Unfunded projects, such as projects conducted by undergraduates, as a part of their educational activities are also exempt from the application of IRB Review Fees;
- Medical records research that is not industry-sponsored;
- Reporting of noncompliance, potential unanticipated problems, or adverse events;
- Applications involving a non-research use of a Humanitarian Use Device;
- Application for emergency or one-time use of an investigational drug or device.
Human Subjects Research Budgets
Researchers need to account for applicable IRB Review Fee 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
Update - Effective March 15, 2010, the method of billing IRB fees will be changed from recharging the campus departments via Interdepartmental Billing (IB) to directly invoicing the private sponsor. The Office of Research -Budget & Finance unit will use the DaFIS Financial System -Accounts Receivable module to invoice the sponsoring agency for IRB fees.
For questions regarding:
IRB Fee invoicing/billing– firstname.lastname@example.org
Contract negotiation – Clinical Trials – Erick Jenkins (email@example.com; 916-734-2345)
Contract negotiation – other than “clinical trials” - Sponsored Programs, Office of Research
IRB review – Contact the IRB