The Institutional Review Board (IRB) at Penn has an existing process to bill IRB fees for submissions. A signed memorandum from the Vice Provost of Research, Dr. Dawn Bonnell, is available for your records.
This process includes the following review fees:
The current IRB fee schedule for studies where the study is industry-sponsored is the following:
- Initial Review*: $2400
- Continuing Review: $1000
- Modifications requiring convened review or deemed complex: $500
- Administrative Review where Penn is the relying IRB: $500
*NOTE: The Initial Review fee is charged even if the study does not commence at Penn, but the IRB review occurred.
All budgets that are negotiated for studies that are industry sponsored should include 3 line items for IRB fees: Initial, Continuing Review(s) (with the number of reviews being based off the proposed duration of the protocol) and modification(s) (which should be captured as invoiced per occurrence).
These IRB fees should be included in contract negotiations, including initial review whether the study contract is finalized or not; it should be a line item in the budget of the formal contract as an upfront and non-refundable item. ORS will help you with this if needed. Most industry sponsors are aware of IRB fees and have included funds for initial review, continuing reviews and modifications.
Single IRB of Record (sIRB) Federally Funded Studies
The IRB may charge fees for serving as the single IRB of Record (sIRB) for federally funded, multi-site studies for any grant proposals submitted to the NIH after January 2018. The NIH policy states that the IRB of Record should bill for additional administrative fees for external site reviews as direct costs.
The current IRB fee schedule for studies where the Penn IRB is serving as the sIRB is the following:
- Initial Review (per relying site): $1400
- Continuing Review (per relying site with study activity during the last approval period): $600
- Modification (fee per affected relying site) excluding administrative and/or minor revisions: $300
*NOTE: If a relying site is not affected by a modification submitted to the sIRB or if a site has minimal or no activity at the time of request for continuing approval, the fee will not be assessed for that specific submission.
These fees should be included in grant proposals for federally funded, multi-site trials for any grant proposals submitted after January 2018. If you have any questions about whether IRB review fees should be included in your proposal budget for multi-site research where you are asking the Penn IRB to serve as the single IRB of record (sIRB), please contact Patrick Stanko.
Single IRB of Record (sIRB) for Industry-Sponsored Studies:
The sIRB fees described above are in addition to the general fee schedule described under Industry-Sponsored Studies.
Other Important Information
The information needed by the IRB to complete the billing should be included in the HS-ERA application section regarding Industry Sponsored protocols; this section will require you to include an internal financial contact (business administrator) and fund number or budget code. This information should be included at the initial submission, whether the contract is pending or not. The application should also be updated when the contract is complete, that is, changed from pending to finalized.
As of January 4, 2016, the IRB started invoicing and journaling these fees from your departmental research accounts. The billing for IRB fees should be part of your routine invoicing to your funding sponsor. In addition, the IRB will begin requesting follow-up from either the department Business Administrator or Study personnel if the IRB fees remain unpaid.
As of May 6, 2021, if the IRB billing office is unable to secure a budget code for the charges from the department within two months from the date of billing, they will automatically charge the department’s 01XX01 Fund. It will then be the responsibility of the department to reallocate the charges to the correct sponsor project fund.
If you have any questions regarding the content of this memo or how to move forward with budget negotiations related to IRB fees, please feel free to contact Edward Fong, IRB Billing & Financial Business Administrator at email@example.com or 215-573-0791.
Thank you for your ongoing commitment to human research at the University of Pennsylvania.