IRB Fees
GEORGETOWN UNIVERSITY INSTITUTIONAL REVIEW BOARD FEE SCHEDULE
IRB fees should be included in contract negotiations, including initial IRB review, whether the study contract is finalized or not. These fees 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 Georgetown, but the IRB review occurred.
STUDIES SUBMITTED AS OF JULY 1, 2023
All new studies with industry/commercial sponsors submitted to the IRB on or after July 1, 2023, 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.
| Institutional Review Board Review of Industry Funded Research | ||
|---|---|---|
| Review Level | Review Type | Fee |
| Full Board | New Protocol Submission | $3,000.00 |
| Full Board | Continuing Review | $1,500.00 |
| Full Board | Amendment* | $1,000.00 |
| Expedited Review | New Protocol Submission | $2,500.00 |
| Expedited Review | Continuing Review | $500.00 |
| Expedited Review | Amendment* | $500.00 |
| Exempt Review | New Protocol Submission | $1,000.00 |
| Expedited Review | Closure Fee | $350.00 |
*IRB fees will not be applied to administrative changes such as staff changes
or IRB required administrative updates.
| IRB Administrative Review of Industry Funded External IRB Submissions | ||
| Review Level | Review Type | Fee |
| Administrative | Initial Review | $2,000.00 |
| Administrative | Annual Administrative Fee** | $1,500.00 |
| Administrative | Close Out | $350.00 |
| Administrative | For Cause Audit | $1,000.00 |
** Modifications and Continuing Review (Inclusive, and billed annually)
SINGLE IRB SERVICES
Georgetown IRB does not provide Single IRB services for multi-center studies. Ensure you work with the budgeting office to incorporate appropriate fees into your budget for use of an external IRB that provides Single IRB services. Please contact IRBoard@georgetown.edu for questions or resources regarding Single IRB services.
STUDIES SUBMITTED PRIOR TO JULY 1, 2023
All studies submitted prior to July 1, 2023 will remain on the old fee schedule, as outlined below. All budgets that are negotiated for studies that are industry sponsored should include 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.
| Institutional Review Board Review of Industry Funded Research | ||
| Review Level | Review Type | Fee |
| Full Board | New Protocol Submission | $2,500.00 |
| Full Board | Continuing Review | $650.00 |
| Full Board | Amendment | $650.00 |
| Expedited Review | New Protocol Submission | $650.00 |
| Expedited Review | Continuing Review | $500.00 |
| Expedited Review | Amendment* | $500.00 |
| Expedited Review | Closure Fee | $200.00 |
*IRB fees apply only to non-administrative changes of study documents requiring IRB review.
| Administrative Review of Commercial IRB Approved Research | ||
| Review Level | Review Type | Fee |
| Administrative | Initial Review | $2,000.00 |
| Administrative | Continuing Review | $500.00 |
| Administrative | Close Out | $200.00 |
| Administrative | For Cause Audit | $1,000.00 |
HOW TO REFLECT FINANCIAL INFORMATION IN THE IRB SYSTEM
The information needed by the IRB to complete the billing should be included in the IRB application on the Study Funding Sources Page. Please add the appropriate Georgetown grant number (GR Number) on the Study Funding Sources page under Grants Office ID. This information should be included at the initial submission. The application should also be updated through a modification as needed when the contract is complete or the funding changes
INVOICING OF FEES
Beginning on July 1, 2023, if the IRB billing office is unable to secure a grant or award number from the study team within three months from the date of initial IRB approval, the IRB may automatically charge the departmental account. It will then be the responsibility of the department to reallocate the charges to the correct sponsor project fund.
IRB ARCHIVED FILE REQUEST
Study teams are expected to maintain their own documents according to federal, institutional and departmental guidelines. In the event that a study team needs to access inactive, archived regulatory files maintained by the IRB, an IRB Archived File Request form must be submitted.