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.
IRB Recharge Rates
The following rates are in effect as of July 1, 2021. 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.
|
|
Initial Full Committee Review |
Renewal of Full Committee Reviews (Continuing Review)** |
Initial Expedited Review* |
Renewal of Expedited Review |
Modification |
|
Protocols funded by private industry (institutional indirect costs are not included in this rate) |
$3630 |
$2030 |
$1210 |
$1210 |
$230 |
|
Protocols submitted on behalf of |
$4570 |
$2550 |
$1530 |
$1530 |
$290 |
|
Protocols submitted on behalf of |
$4570 |
$2550 |
$1530 |
$1530 |
$290 |
| Federally funded or unfunded UCSF Investigator-Initiated protocols | No Charge | No Charge | No Charge | No Charge | No Charge |
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.
* External IRBs: Studies that use external IRBs will be charged the expedited review rate, which should be budgeted into the clinical trial agreement.
** Continuing reviews occur at intervals defined by the IRB. However, continuing reviews may occur more frequently. In particular, the PI may submit a continuing review early if there is a protocol amendment from the sponsor that includes major changes to the study (e.g., a new study arm is added or removed). In such cases, the IRB can review the change at a convened meeting as required, and re-approve the study.
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.
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 2013 and have not been increased since.
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.