700-10-Criteria for IRB Approval
| Title: |
Criteria for IRB Approval |
| Owner: |
IRB |
| Last Update/Revised: |
05/01/2024 |
Policy: All research proposals that intend to enroll human subjects as participants must meet certain criteria before study related procedures can be initiated. Three core principles: respect for persons, beneficence, and justice, as discussed in the Belmont Report, are the basis of the criteria for IRB approval. All regulatory criteria must be met prior to approval. In addition, certain other criteria that are unique to the USU may apply and must be met as well (see 700-3: USU as a Minimal Risk Institution, 700-14: Research Activities Not Permitted at USU, and 211: Research on USU Constituents).
Purpose: The purpose of this policy is to explain criteria used to determine if the IRB will approve a study.
Procedures:
- To ensure that all regulatory criteria and any other applicable requirements are met, the IRB uses a checklist system. The criteria for approval and other applicable requirements are included in the IRB Reviewer Checklists.
- Assigned IRB reviewers must complete the appropriate checklist to ensure that the criteria for approval and other applicable requirements are met. More detailed information about the criteria for approval and other applicable requirements is provided according to specific types of research.
Scope: This policy pertains to research activities that do not receive a determination of not human subjects research or exempt research.
Documents and Forms:
IRB Reviewer Checklist (available on IRB Google Drive)