Studies Subject to IRB Review Fees
The IRB charges for the review of the following types of human research studies:
- All studies funded by private industry
- All studies submitted on behalf of UCSF-affiliated institutions. This includes the following entities: NCIRE, Gladstone Institutes, Institute on Aging, SF Coordinating Center, Vitalant and the Vitalant Research Institute, SFDPH, ZSFG, and SFVAHCS.
- Multisite studies for which UCSF is the sIRB
IRB Fee Schedule
The following rates are in effect as of July 1, 2024. These rates reflect current operating costs and are in line with national standards. Contact our office with billing questions. UCSF departments (not including “UCSF affiliated institutions”) pay the IRB fees through the recharge process.
Fee Chart 1: Fees for Studies Reviewed by the UCSF IRB
Note: This table does not include fees for (a) reviews of submissions for relying sites for studies where UCSF is the sIRB, or (b) studies where UCSF is relying on an external IRB. For those rates, see Fee Charts 2 and 3.
|
Initial Full Committee Reviews |
Renewal of Full Committee Reviews (Continuing Review) |
Initial Expedited Reviews |
Renewal of Expedited Reviews |
Modifications, Personnel Changes, Enrollment Exception Requests |
|
|---|---|---|---|---|---|
|
Protocols funded by private industry (institutional indirect costs are not included in this rate) |
$3930 |
$2140 |
$1540 |
$1540 | $290 |
|
Protocols submitted by • Vitalant • See full list of UCSF affiliates |
$4960 |
$2700 |
$1950 |
$1950 | $370 |
|
Federally funded or unfunded UCSF Investigator-Initiated protocols |
No Charge |
No Charge |
No Charge |
No Charge | No Charge |
Fee Chart 2: Fees for Multi-Site Studies where UCSF is the sIRB* (UCSF is serving as the single IRB of Record for all participating sites)
Important information about this table:
- These fees will be implemented on new sIRB studies submitted to the IRB for Initial Review on or after October 1, 2024. Studies that have IRB approval prior to October 1st and then add relying sites on/after October 1st will not be subject to these fees.
- These fees are for each relying site.
- These fees are additional to the costs of the review for the UCSF study site, which are outlined in Table 1.
|
Initial Full Committee Reviews |
Renewal of Full Committee Reviews (Continuing Review) |
Initial Expedited Reviews |
Renewal of Expedited Reviews |
Modifications, Personnel Changes, Enrollment Exception Requests |
|
|---|---|---|---|---|---|
|
Protocols submitted by • Vitalant See full list of UCSF affiliates (Primary site is UCSF affiliated institution) |
$1550 per relying site
|
$720 per site
|
$1430 per site
|
$720 per site
|
$170 per affected site
|
|
Protocols submitted by UCSF
(Primary site is UCSF) |
$1230 per relying site |
$570 per site |
$1130 per site |
$570 per site |
$130 per affected site |
*Guidance about the sIRB Mandate is available here: https://irb.ucsf.edu/nih-single-irb-mandate
Examples of sIRB Study Fee Assessments
Initial reviews of UCSF or affiliate sites plus relying sites:
Post-approval reviews for studies with relying sites:
*The NIH provided further guidance through various scenarios to illustrate how costs are handled in different sIRB arrangements. See https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-109.html#_ftn1
Fee Chart 3: Fees for Studies Relying on an External (Non-UCSF) IRB
Studies that use external IRBs first need to obtain permission from the UCSF IRB. This review process will be charged the expedited review rate from Table 1. These fees should be budgeted into the clinical trial agreement. Charging for the reliance on an external IRB has been our standard practice for some time, ensuring that we can adequately support the necessary review processes.
|
|
Initial Full Committee Reviews |
Initial Expedited Reviews |
Modifications, Personnel Changes |
|---|---|---|---|
|
Industry-funded studies where the UCSF researchers rely on an external (non-UCSF) IRB |
$1540 |
$1540 |
$290 |
Important Note: There will be no charge for adverse event reports or violation/incident reports submitted to the IRB for review and processing. For additional information, please review the FAQs below.
Continuing reviews occur at intervals defined by the IRB, typically annually. However, continuing reviews may occur more frequently.
FAQs
The following questions are the most common ones that have been asked about the recharge for IRB review for industry-sponsored studies and studies being conducted by the affiliated institutes.
Individual investigators will be charged after IRB review has occurred, whether or not the study is finally funded.
- Internal UCSF investigators will be charged through a journal recharge
- External investigators will be charged through an invoice sent directly to the institution
Important Note: For both UCSF-affiliated institutions and non-affiliated institutions or organizations, Maria Velasco at (415) 502-2180, HRPP Business Analyst, bills the institutions directly, not the individual PIs.
If the IRB review has already taken place, the investigator or the institute will still be charged.
Investigators should list the expense for IRB review as a budget line item as part of the start up costs.
Continuing Review fees will not be waived after the sponsor funding has ended. Once the sponsor has closed UCSF as a site, the study team should start the process of preparing to close the study. Activities such as ensuring all billable procedures have been submitted to the sponsor or patients’ insurance providers and all study-related costs have been reimbursed should be completed before the study fee account is closed.
As soon as the study fee account is closed the PI should submit a Study Closeout Form to the IRB. FDA requires investigators to submit closeout reports to the IRB for all FDA-regulated research and submission of a Study Closeout Form after completion of the study is a requirement at UCSF. If the PI wishes to continue analyzing the data beyond the period of sponsor involvement, the PI should de-identify the data or transfer coded data into a separate IRB-approved research database. The Study Closeout Report has a section for explaining plans for post-study disposition of study data.
In general, there are no cases in which waivers for the charge may be granted. However, if an investigator believes there are special circumstances, they may request a waiver in writing. Approvals for waivers will be rare and will be approved by the Director of the HRPP in consultation, as needed, with the Associate Vice Chancellor for Research.
All IRB reviews will be charged, including industry-sponsored studies after the contract has ended and studies in Data Analysis Only status.
If funding for a study submitted on behalf of an affiliated institution ultimately does not get awarded the IRB review fees are still due. Affiliates may choose to restrict IRB submission until after funding has come through to ensure that costs are not incurred for studies that don’t receive funding.
Is UCSF unusual in charging for IRB review? Are the charges at UCSF in line with other institutions?
No, most academic medical centers throughout the country charge for IRB review. The charges are similar to many academic institutions, lower than many others, and lower than external IRBs. The current rates were set in July 1, 2024.
The rates were determined based on cost according to University procedures, and were reviewed and approved by the UCSF Budget Office. The charge for affiliated institutes is higher because an indirect cost charge is added to these as mandated by the Budget Office, in accordance with University policy.
If you are unsure how to complete the Funding section of the IRB application, please call the IRB office at (415) 476-1814 and ask to speak with the Analyst of the Day.