IRB Review Fees

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Studies Subject to IRB Review Fees 

IRB Recharge Rates

FAQs

 

Studies Subject to IRB Review Fees

The IRB charges for the review of the following types of human research studies:

  • Studies funded by private industry
  • Studies submitted on behalf of UCSF-affiliated institutions (e.g., NCIRE, the Gallo Center, the Gladstone Institutes)
  • Studies submitted on behalf of non-UCSF organizations (e.g., the San Francisco Department of Public Health, the Blood Centers of the Pacific)

IRB Recharge Rates

The following rates are in effect as of July 1, 2013. These rates reflect current operating costs and are in line with national standards. For billing questions, contact Bruce Miller by email at Bruce.Miller3@ucsf.edu or call 415-502-2180. 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
(Continuing Review)**

Modification

Exempt Certification

Protocols funded by private industry (institutional indirect costs are not included in this rate)

$2700

$1200

$700

$700

no charge

no charge

Protocols submitted on behalf of
UCSF affiliated institutions, i.e.,
• Gallo
• Gladstone
• NCIRE

$4500

$2000

$1200

$1200

no charge

no charge

Protocols submitted on behalf of
non-UCSF organizations, i.e.,
• Blood Centers of the Pacific
• SFDPH

$4500

$2000

$1200

$1200

no charge

no charge

Important Note: There will be no charge for modifications, adverse event reports or violation/incident reports submitted to the IRB for review and processing. For additional information, please review the FAQs below.

* Western IRB (WIRB): Studies that use WIRB 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.

When will the PI be charged?

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, Judy Der at 415-502-2180, Assistant to the HRPP Director, bills the institutions directly, not the individual PIs.

What happens if the contract is not approved?

If the IRB review has already taken place, the investigator or the institute will still be charged.

How are investigators expected to cover the extra costs of these charges?

Investigators should list the expense for IRB review as a budget line item as part of the start up costs.

Are there any exemptions to these charges?

Yes, a junior investigator (Assistant Professor) who is submitting his or her first industry-sponsored clinical trial will not be charged. In order to receive a waiver, however, the investigator must submit a written request for an exemption attached to the application.

In general, there are no other cases in which waivers for the charge may be granted. However, if an PI believes there are special circumstances, he or she 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.

For Gallo, Gladstone, NCIRE, and other affiliated and non-affiliated institutions, will there be a charge for each protocol reviewed or only those funded by private industry?

All IRB reviews will be recharged.

Is there any plan to expand this charge to NIH-funded studies or to studies funded by foundations?

There are currently no plans to expand this recharge. However, the NIH is considering adding a line item in its budget for IRB review.

Is UCSF unusual in charging for IRB review? Are the charges at UCSF in line with these other institutions?

Many other academic medical centers throughout the country charge for IRB review and many other institutions are considering doing so. The charges are in line with other academic institutions and certainly lower than private IRBs.

How were the charges determined?

The amount of recharge was determined based on cost according to University procedures and was 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.

What if I don't know my funding source?

The Funding section of the IRB application must be completed before IRB review can occur. 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.