Updated IRB Review Fees Effective July 1st (Non-sIRB studies) and October 1st (New sIRB studies)

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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?
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.

ProtocolInitial Full Committee ReviewsRenewal of Full Committee Reviews (Continuing Review)Initial Expedited ReviewsRenewal of Expedited Reviews
(Continuing Review)

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
UCSF affiliated institutions, e.g.,
• Gladstone
• NCIRE

• Vitalant
• SFDPH

• See full list of UCSF affiliates

$4960$2700$1950$1950$370
Federally funded or unfunded UCSF Investigator-Initiated protocolsNo ChargeNo ChargeNo ChargeNo ChargeNo 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. 
ProtocolInitial Full Committee ReviewsRenewal of Full Committee Reviews (Continuing Review)Initial Expedited ReviewsRenewal of Expedited Reviews
(Continuing Review)

Modifications,

Personnel Changes,

Enrollment Exception Requests

Protocols submitted by
UCSF affiliated institutions, i.e.,
• Gladstone
• NCIRE

• Vitalant
• SFDPH

(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: /nih-single-irb-mandate

Examples of sIRB Study Fee Assessments
Initial reviews of UCSF or affiliate sites plus relying sites:

Initial full board review, non-industry-funded study, UCSF is the IRB of record for 2 relying sites, UCSF is the primary site:

Initial review of UCSF site: No chargeEach relying site : $1230 x 2 relying sites = $2460Total: $2460

Initial full board review, industry-funded study, UCSF is the IRB of record for 2 relying sites, UCSF is the primary site:

Initial review of UCSF site: $3930Each relying site : $1230 x 2 relying sites = $2460Total: $6390

Initial full board review submitted by an affiliated institution, UCSF is the IRB of record for 2 relying sites:

Initial review of affiliate site: $4960Each relying site : $1550 x 2 relying sites = $3100Total: $8060

Initial expedited review, non-industry-funded study, UCSF is the IRB of record for 2 relying sites, UCSF is the primary site:

Initial review of UCSF site: No chargeEach relying site : $1130 x 2 relying sites = $2260Total: $2260

 

Post-approval reviews for studies with relying sites:

Study-wide modification, non-industry-funded study, UCSF is the IRB of record for 2 relying sites, UCSF is the primary site:

Modification to UCSF site: No chargeModification to each onboarded site: $130 x 2 relying sites=$260Total: $260

Study-wide modification, industry-funded study, UCSF is the IRB of record for 2 relying sites, UCSF is the primary site:

Modification to UCSF site: $290Modification to each onboarded site: $130 x 2 relying sites=$260Total: $550

Study-wide modification submitted by an affiliated institution, UCSF is the IRB of record for 2 relying sites:

Modification to affiliate site: $370Modification to each onboarded site: $170 x 2 relying sites=$340Total: $710

Modification that affects a single relying site (e.g., site-specific consent form changes), UCSF is the primary site:

Modification to the affected site: $130Total: $130

Modification that affects a single relying site (e.g., site-specific consent form changes), an affiliate institution is the primary site:

Modification to the affected site: $170Total: $170

Full board continuing review, non-industry-funded study, UCSF is the IRB of record for 2 relying sites, UCSF is the primary site:

Continuing Review of UCSF site: No chargeContinuing review of each onboarded site: $570 x 2 relying sites=$1140Total: $1140 per renewal period (no less than once per year)

Full board continuing review, industry-funded study, UCSF is the IRB of record for 2 relying sites, UCSF is the primary site:

Continuing Review of UCSF site: $2140Continuing review of each onboarded site: $570 x 2 relying sites=$1140Total: $3280 per renewal period (no less than once per year)

*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.

ProtocolInitial Full Committee ReviewsInitial Expedited Reviews

Modifications,

Personnel Changes

Industry-funded studies where the UCSF researchers rely on an external (non-UCSF) IRB$1540$1540$290

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