IRB Fee

Effective January 1, 2007, the process for collecting IRB review fees for human research sponsored by commercial companies will change.

Current process: Currently, investigators submitting commercial sponsored clinical trial agreements to the Office of Sponsored Projects (OSP) are required to include a line item in the study budget for the IRB fee. OSP invoices the study sponsor once the contract is signed and collects the fee for the IRB Office.

New process: The IRB Office will now bill for the fees. After a commercial sponsored clinical trial has been reviewed by the IRB, the IRB Office will invoice the study sponsor and collect the fee. The IRB fee will be collected whether or not a contract is executed.

General information about IRB fees: The fee for the initial review of a human research protocol reviewed by the IRB is $2,000. This one-time fee applies only to those studies undertaken for commercial companies who are sponsoring a drug or device protocol. Clinical trials supported by federal funds do not incur this fee. No F&A (indirect) cost will be assessed against the fee, and no additional charges will be assessed for the required annual re-review or protocol amendments.

The OSP and the IRB Office will work closely over the next several months to close out outstanding fees invoiced under the current system and transition to the new process.