IRB Review Process
IRB staff perform an initial review to ensure the application is complete. Based on this review, the IRB may determine the project does not meet the regulatory definition of human subject research, the project is exempt, the project is eligible for expedited review, or the project must be reviewed by a convened board.
Applications that do not qualify for exemption or expedited review are reviewed by a convened board.
Please Note: For profit and/or industry sponsored studies must pay IRB fees before the review process begins. IRB Fee Schedule
| Review Type | Approximate Time Requirement |
|---|---|
| Non-Human Subject Research Determination | 1 week |
| Exempt Review | 1 week |
| Expedited Review | 4-6 weeks |
| Convened Board Review | 4-6 weeks |
Criteria for Approval
The IRB will only approve research projects that meet the minimum criteria for approval established by the Department of Health and Human Services and the Food and Drug Administration. These criteria are described in 45 CFR 46.111 and 21 CFR 56.111.
Criteria for Disapproval
The IRB will disapprove a proposal for the following reasons:
- It violates the law or regulations of the United States, State of Utah, or the University of Utah
- The risk to the participant outweighs the benefit (personal or societal)
- Unnecessary risk is created
- Selection of subjects is not equitable
- Procedures for obtaining and documenting informed consent are inadequate
- Payment or other inducements are likely to influence participant judgment
- Poor or improper design such that meaningful conclusions cannot be derived
- Promotional (seeding) design that is not scientific in nature