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Review Fees

 

UCLA OHRPP Policy

 

IRB review fees are charged for industry-sponsored clinical trials as new clinical trial agreements are negotiated. A onetime fee of $2,500 will be charged for the review of new industry-sponsored clinical trials that meet the following conditions:

  • Designed to assess in humans the safety, efficacy, benefits, adverse reactions, and/or other outcomes of drugs, devices, diagnostics, treatments, procedures, medical evaluations, monitoring or preventive measures; and
  • Fully supported by an industry sponsor; and
  • Comply with UC Operating Requirement 95-5 "Requirements for Administration of Agreements with Private Sponsors for Drug and Device Testing Using Human Subjects."

IRB review fees are not charged for clinical studies supported by the National Institutes of Health (NIH) or other government agencies, investigator-initiated studies, or industry-sponsored studies that do not meet the UCLA definition of a clinical trial outlined above.

 

Click here to view the July 3, 2012 memo from the Vice Chancellor for Research regarding the change in the rate and structure of the IRB review fees charged for industry-sponsored clinical trials.

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Rates for Recharge of IRB Reviews

 

The following rates are effective July 1, 2012.

 

For Industry-Sponsored Clinical Trials

Initial Full Committee Review

Renewal of Full Committee Reviews

(Continuing Review)

Initial Expedited Review

Renewal of Expedited Review

(Continuing Review)

Amendment

Exempt Certification

$2,500

no charge

$2,500

no charge

no charge

no charge

Important Note: There is no charge for adverse event reports submitted to the UCLA-OHRPP for review and processing. For additional information please review the Frequently Asked Questions below.

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FAQs about the UCLA-OHRPP Charge for Review

 

The following questions are the most common ones that have been asked about the recharge for UCLA-OHRPP review for industry-sponsored studies.

 

When does the increase in IRB review fees take effect?

The $2,500 rate for IRB review applies to all new contracts submitted on or after July 1, 2012.

 

When and how will these fees be paid?

The IRB fee is to be budgeted as a separate line item in the contract budget and reimbursed by the sponsor at the time of contract execution. The invoicing and collection of the fee will be managed by the Office of Research Administration with assistance from the School of Medicine Clinical Trial Administration Office.

 

How do investigators cover the costs of these charges?

Investigators should list the expense for IRB review as a budget line item as part of the start-up costs. IRB fees ($2,500) should be included in clinical trial budgets. However, since the fees are not subject to F&A charges, they should be listed as a separate line item, and not included in the F&A calculation.

 

Will there be a charge for modifications of existing studies?

No, there will be no charge for continuing renewals, amendments or modifications.

 

Will there be a charge for submitting adverse event reports or incident reports?

No, there will be no charge for either action.

 

Will there be a charge for Exempt Certifications?

No, there will be no charge for exempt certifications

 

Who do I contact if I have questions?

If you have questions about the collection of the IRB fee, please contact Marcia Smith in the Office of Research Administration. For questions about budgeting or negotiating the fee with industry sponsors, please contact Helene Orescan in the Clinical Trials Administration Office.

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Page Last Updated: July 5, 2012