Fees

The Following IRB Fees Are in Effect

Beginning April 1, 2022:

1. the study is funded by the federal government; or by a university or another non-profit entity; or
2. the study is investigator-initiated; or
3. the study uses an external IRB as its IRB-of-Record, and the DUHS IRB performs an administrative review; or
4. the activity qualifies for expedited review, or is declared exempt from further IRB review by an IRB Chair/designee.

There will be no charge for Single Patient Treatment Use/Single Patient Expanded Access Requests.

All investigators submitting industry‐sponsored research protocols to the IRB are required to include a separate line item in the protocol budget for initial review, continuing review, and amendments that require convened IRB review.  Fees for continuing review will be charged annually until a Final Report form is received by the IRB office. 

Fees are assessments of actual costs associated with protocol review by the IRB and are charged for services rendered. Because the IRB office commits its full resources to each review, the fees are due in full even if the IRB does not approve the study, subjects are never enrolled, a research contract is never executed, or the study is terminated before objectives are achieved. IRB fees are non‐refundable. 

All continuing reviews and amendments will be charged based on the fee structure in effect at the time of the Initial Approval by the IRB.  The fees in effect at the time of Initial IRB Approval will be applied in perpetuity, for the life of the project.  If the Initial Approval date is 4/1/2022 or after, then the rates above apply.

Any requests for exception should be submitted by the CRU Medical Director to Sharon Ellison, PharmD, DUHS IRB Executive Director.