IRB Review Fees

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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 and the Gladstone Institutes)
  • Studies submitted on behalf of non-UCSF organizations (e.g., the San Francisco Department of Public Health, Vitalant (formerly 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. 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
(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.,
• Vitalant (formerly 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.

* 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.

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, Maria Velasco at 415-502-2180, HRPP Business Analyst, 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.

I'm a UCSF investigator and the contract for my industry-sponsored has ended, but my department was charged for Continuing Review for a Data Analysis Only study.  Why am I being charged for that review?

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.

Are there any exemptions to these charges?

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.

For 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 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 these 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 2013 and have not been increased since.

How were the charges determined?

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.

What if I don't know my funding source?

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.