Review of IRB Submission Package

When your submission is ready for IRB review, you will submit it to the IRB. An IRB administrator will review the documents, and assuming all documents are complete, your proposed activity will be reviewed and placed into one of the following 8 categories. You will receive an email that details the next steps (see Figure 1 - IRB Decision Tree) for a visual):

1. Not Human Subjects Research (e.g., QI projects, secondary data analysis on de-identified data, etc.). Reviewing this type of project/research takes up to 5 business days.

2. Exempt Determination. The review for this type of research takes up to 5 business days.

3. Approved (Expedited or Full Board Review). The review for expedited research takes up to 7 business days, while the approval of research requiring full board review takes up to 21 days.

4. Conditional Approval - This category is only applicable when a project/study is being conducted at another organization, and this organization requires conditional approval prior to providing documents that will be required with your USU IRB submission. This type of review requires a variable amount of time, depending on whether the proposed activity is: Not Human Subjects research or Exempt (5 business days), Expedited (7 business days), or Full Board Review (up to 21 business days).

5. Modifications Required - This category is used if your materials are incomplete or require modifications. This type of review requires a variable amount of time, depending on whether the proposed activity is: Not Human Subjects research or Exempt (5 business days), Expedited (7 business days), or Full Board Review (up to 21 business days).

6. Disapproved - The IRB has met and conducted a full board review and has all the information it needs to make a determination, but the study does not meet the criteria for approval. The review for research requiring a full board review takes up to 21 business days.

7. Deferred - This disposition is only used if a quorum is not met for a full board review. The review for research requiring a full board review takes up to 21 business days.

8. Other IRB of Record – This category is used if another IRB has already reviewed your project/study. This economizes the IRB process by limiting the IRB review to one organization. Even if you have an official letter from another IRB, the IRB at USU must receive this letter via the IRB review process and send you official communication that you may proceed with your project/study. Reviewing projects/research overseen by another IRB requires up to 5 business days.