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 outlined below.
As of Fiscal Year 2022-2023, the review fee schedule for industry sponsored research will change. This change was based on a review of multiple peer institution IRB fee schedules. The new fee schedule is in line with the median and average rates across peer institutions.
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. The contracts office will help you with this if needed. Most industry sponsors are aware of IRB fees and have included funds for IRB review.
NOTE: The Initial Review fee is charged even if the study does not commence at Penn, but the IRB review occurred
Studies Submitted as of July 1, 2022
All new studies with industry/commercial sponsors submitted to the IRB on or after July 1, 2022, should include the new IRB fee schedule as outlined below. All budgets within this timeframe that are negotiated for industry sponsored studies should include the following 4 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), and Closure.
|Reliance Agreement Single Administrative Fee||$1500|
Studies Submitted Prior to July 1, 2022
All studies submitted prior to July 1, 2022 will remain on the old fee schedule, as outlined below. 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).
Modifications requiring convened review or deemed complex
Initial Administrative Review where Penn is the relying IRB
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 outlined below. These fees should be included in grant proposals for federally funded, multi-site trials for any grant proposals submitted after January 2018.
NOTE: If a relying site is not affected by a modification submitted to the sIRB, OR if a site has minimal to no activity at the time of request for continuing approval, a fee will not be assessed for that specific site.
Initial Review (per relying site)
Continuing Review (per relying site with study activity during the last approval period)
Modification (fee per affected relying site) excluding administrative and/or minor revisions
Other Important Information
How to Reflect Financial Information in HSERA
The information needed by the IRB to complete the billing should be included in the HS-ERA application on the Sponsor Page. An internal financial contact should be listed under Business Administrator. Please add the appropriate fund number or budget codes on this page. 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, or when any other changes are made (e.g., new funding added).
Invoicing of Fees
- Beginning in 2016, the IRB started invoicing and journaling IRB 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.