As of July 1, 2023, the University of Virginia will implement a new fee structure for industry sponsored clinical trials requiring full board IRB review.
The fee will be charged for studies for which the UVA IRB HSR is the IRB of record as well as those studies that are being conducted under a non-UVA IRB.
The fee is NOT charged for Expanded Access Protocols. Under FDA regulations (21 CFR 312.300), expanded access is the use of an investigational drug/biologic (referred to as “test article”) outside of a clinical trial for the diagnosis, monitoring, or treatment of a serious disease or condition when there is no satisfactory alternative therapy to treat the patient’s disease or condition.
This fee ONLY applies if the Principal Investigator for the protocol is from the School of Medicine.
This fee is made after the study has been approved by the IRB-HSR Convened Full Board and the Contract office has opened an account.
This fee structure applies to all studies for which the Clinical Trial Agreement (CTA) is executed on or after July 1, 2023.
The revised fee structure is as follows:
|
Service |
Charge |
|
UVA-HSR as IRB of record: initial review |
$3,500 |
|
Reliance on an outside IRB: initial review |
$3,500 |
|
UVA-HSR as IRB of record: yearly fee (billed at annual continuation) |
$2,000 |
|
Reliance on an outside IRB: yearly fee (billed at annual continuation) |
$1,000 |
|
UVA-HSR serving as sIRB of record for non-UVA sites: initial review |
$1,000 per site |
|
UVA-HSR serving as sIRB of record for non-UVA sites: yearly fee (billed at annual continuation) |
$500 per site |
|
Study close-out |
$2,500 |
Note: The fee is considered a direct cost and is subject to F&A. Information regarding F&A may be found on the Office of Sponsored Programs.
Questions regarding this fee may be referred to the School of Medicine Clinical Trials office at 434-924-8570.