NOTE: Exempt means that the Federal Government has “exempted” specific categories of studies from the Code of Federal Regulations. IT DOES NOT MEAN THAT A PROJECT IS EXEMPT FROM IRB REVIEW. The AU IRB determines which projects fit into the exempt categories and then completes an “exempt review” in accordance with principles and guidelines for the ethical conduct of human subject research.

Exempt Categories

Exempt Process

1. Investigator submits one hardcopy of protocol requests to the OHSR. There are no deadlines for submissions for exempt review.
   • The IRB reserves the right to assign any protocol to Full Board Review.
2.  Submissions are reviewed by an experienced member of the IRB.
3. Approvals or reviewer comments, suggestions, or recommendations are communicated by email from the OHSR to the investigator.
   • Exempt submissions are reviewed within 15 business days, unless workload or unusual circumstances exist where we are unable to meet this goal.
4. Investigators address comments for protocols which require revisions. A complete revised protocol packet, including a memo outlining how each of the IRB’s comments were addressed, must be submitted to OHSR.
5. The OHSR or the IRB, depending on the issues, will review the revisions.
   The investigator will be contacted via email if the revisions do not adequately address the IRB’s comments.
6. The investigator will receive written documentation of protocol approval from the OHSR along with copies of the stamped version of the approved consent document(s) (Informed Consent or Information Letter).
   • When consenting participants, investigators MUST use the approved consent document to which the IRB’s approval stamp has been applied.
7.  This allows the participant to see that the document has been reviewed and approved by the IRB and that the document approval dates are current.
8. All research reviewed and approved under an Exempt category is reported to the full IRB at convened meetings of the Board.
        

Expedited Categories

Expedited Process

1. Investigator submits one hardcopy of protocol requests to the OHSR. There are no deadlines for submissions for expedited review.
   • The IRB reserves the right to assign any protocol to Full Board Review.
2. Submissions are reviewed by the IRB Chairman and/or the IRB Liaison (or other members of the IRB).
   • Expedited Protocol Reviewers are determined based on the proposed research and experience or expertise of the reviewers.
3. Approvals or reviewer comments, suggestions, or recommendations are communicated by email from the OHSR to the investigator.
   • Expedited submissions are reviewed within 15 business days, unless workload or unusual circumstances exist where we are unable to meet this goal.
   • Expedited protocols may be approved, approved pending revisions, or required to be revised and resubmitted for review under this category. However, no research may be disapproved under this process.
4. Investigators address comments for protocols which require revisions. A complete revised protocol packet, including a memo outlining how each of the IRB’s comments were addressed, must be submitted to the OHSR.
5. The OHSR or the IRB, depending on the issues, will review the revisions.
6. The investigator will be contacted via email if the revisions do not adequately address the IRB’s comments.
7. The investigator will receive written documentation of protocol approval from the OHSR along with copies of the stamped version of the approved consent document(s) (Informed Consent or Information Letter).
   • When consenting participants, investigators MUST use the approved consent document to which the IRB’s approval stamp has been applied. This allows the participant to see that the document has been reviewed and approved by the IRB and that the document approval dates are current.
8. All research reviewed and approved under an Expedited category is reported to the full IRB at convened meetings of the Board.
    

Full Board Process

1. Investigator submits one original and 18 copies of protocol requests to the OHSR.
   • Deadlines for submission are posted here. Protocols are due in the Office of Human Subjects Research two weeks before the IRB meeting date. IRB meetings are generally held during the second week of every month. (Exception: Protocols are not reviewed during the August IRB Meeting.).
2. Protocols are assigned primary and secondary reviewers and an Agenda is constructed.
3. All protocols on the Agenda are distributed to the Board members the week prior to the scheduled IRB Meeting.
4. Investigators are notified by email from the OHSR of the IRB’s determination.
5. IRB comments, suggestions, or recommendations for any protocol requiring revisions or resubmission are communicated by email from the OHSR to the investigator.
6. Investigators address comments for protocols which require revisions. A complete revised protocol packet, including a memo outlining how each of the IRB’s comments were addressed, must be submitted to the OHSR.
7. The OHSR, the IRB, or selected IRB Member(s), depending on the issues, will review the revisions.
8. The investigator will be contacted via email if the revisions do not adequately address the IRB’s comments.
9. The investigator will receive written documentation of protocol approval from the OHSR along with copies of the stamped version of the approved consent document(s) (Informed Consent or Information Letter).
   • When consenting participants, investigators MUST use the approved consent document to which the IRB’s approval stamp has been applied. This allows the participant to see that the document has been reviewed and approved by the IRB and that the document approval dates are current.
      

IRB Meeting Schedule/Protocol Deadlines