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Review Fees

Phronetik OHSR Policy

IRB review fees are charged for industry-sponsored clinical trials as new clinical trial agreements are negotiated. A onetime fee of $3,500 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 Phronetik Operating Requirements for Administration of Agreements with Private Sponsors for Drug and Device Testing Using Human Subjects.

As of January 1, 2023, there will be a new fee of $2200 charged for any industry-sponsored clinical trial that utilizes a reliance mechanism for the IRB review and approval.

 

Each study that uses a human research protocol requires review and ongoing oversight by the Institutional Review Board (IRB)/Human Research Protection Program (HRPP). This process is vital to Phronetik’s ability to conduct research. The fee structure for industry-funded research is to help meet current needs and allow revenue to keep pace with expenditures.

Rates for Charge of IRB Reviews

 

The following rates are effective January 1, 2023.

Important Note: There is no charge for exempt research, amendments, continuing reviews, or post approval reports (PARs) submitted to the Phronetik HRPP for review and processing. For additional information please review the Frequently Asked Questions below.

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

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FAQs about the Phronetik HRPP Charge for Review

The following questions are the most common ones that have been asked about the fee for Phronetik HRPP review for industry-sponsored studies.

When does the increase in IRB review fees take effect?

The new rates for Phronetik IRB review and Reliance Review applies to all new contracts submitted on or after January 1, 2023.

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 Sponsored Research Administration with assistance from Phronetik Office for Research.

 

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 ($3500 for initial Phronetik IRB review and $2200 for Reliance review) 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 post approval reports?

No, there will be no charge for that 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:

Phronetik Research
Office of Sponsored Research
1011 Surrey Lane, BLDG 200
Flower Mound, TX 75022

844.871.3575 | osr@phronetik.com

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