Post Submission Process

  1. A New Information Report is submitted in eIRB+.
     
  2. The IRB review process begins:

    Pre-Review
    The New Information Report will undergo a pre-review by IRB staff to ensure that the submission is complete and in keeping with the IRB’s requirements.  The investigator may be asked to provide additional information.  Once the submission is determined to be complete, it will be routed for IRB review.

    IRB Review:

    1. Expedited Review
      • The submission is sent to an IRB member for review.
      • The submission will receive one of the following determinations:
        • Non-compliance that is neither serious nor continuing,
        • Allegation of non-compliance with no basis in fact, or
        • None of the above.
      • An acknowledgment letter that may or may not request additional actions will be issued through eIRB+. If additional action is specified, a modification or an additional New Information Report must be submitted.
         
    2. Full Board Review
      • The submission will be assigned to a Board meeting for review.
      • The submission will be presented at a convened IRB meeting by a primary reviewer.
      • The submission will receive at least one of the following determinations by the IRB:
        • Unanticipated problem involving risks to subjects or others,
        • Suspension or termination of IRB approval, 
        • Serious non-compliance, 
        • Continuing non-compliance,
        • Non-compliance that is neither serious nor continuing,
        • Allegation of non-compliance with no basis in fact, or
        • None of the above
  • If the IRB determines the reported event constituted a UPIRSO, or serious and/or continuing non-compliance and the study is funded by HHS or subject to FDA regulations, these agencies will be notified by the IRB of this finding.
  • An acknowledgment letter that may or may not request additional actions will be issued through eIRB+. If additional action is specified, a modification or an additional New Information Report must be submitted.