What is Happening?
The IRB is implementing the following fee-related changes:
- IRB review fees will increase on July 1, 2024.
- Multi-site studies subject to sIRB oversight by UCSF IRB will be charged review fees starting October 1, 2024. Note: This only applies to new sIRB studies submitted for initial IRB review on/after October 1.
Why Must Fees Be Increased at This Time?
The IRB’s current fee structure does not sufficiently cover the escalating operating expenses involved in carrying out IRB reviews. Since the last fee adjustment in 2021, an additional review panel was formed in response to a need, and the IRB office has been managing Federally funded sIRB submissions at no cost to the study team. These services are not sustainable without additional revenue.
What Types of Studies are Subject to IRB Review Fees?
- UCSF studies funded by private industry
- Studies submitted by UCSF affiliated institutions
- Multisite studies for which UCSF is the sIRB
What Types of IRB Submissions are Affected by the New Fee Structure?
IRB review fees will increase for the following types of reviews for Full Committee and Expedited studies:
- New studies
- Continuing reviews
- Modifications, Personnel Changes, Enrollment Exceptions, and Adding Relying Sites
- Requests to rely on an external IRB
The new fees are listed below in 3 tables. The “IRB FY25 Updated Fees” document provides a more detailed explanation about why the fees are being increased, including data on work volume and operating costs.
Fee Chart 1: Fees for Studies Reviewed by the UCSF IRB
Note: This chart 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. Examples of how the fees from Tables 1 and 2 may be combined for sIRB studies will be added to the IRB website shortly.
|
|
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
(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
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.
|
|
Initial Full Committee Reviews |
Initial Expedited Reviews |
Modifications, Personnel Changes |
|---|---|---|---|
|
Studies where the UCSF researchers rely on an external (non-UCSF) IRB |
$1540 |
$1540 |
$290 |
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