IRB Review Fees

 

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.
  • Multisite studies for which UCSF is the sIRB

IRB Fee Schedule

The following rates are in effect as of July 1, 2024. 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.

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 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 July 1, 2024.

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?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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