IRB Process

The IRB review process can be broken up into 4 stages. These stages and the standard timelines for each are listed below. The submissions that require review must be reviewed and approved by the IRB before the requested study activity can commence. The linked document provides a visual of this process...

The PI or a designated member of the study team must complete a submission form (for Initial Study Review, Study Continuation, Study Modification, Reporting, or Study Closeout) in the iRIS electronic compliance platform. The submission is reviewed and approved by departmental and School/College/Unit personnel. The study will have a Pending status until an outcome has been made by the IRB.

Pre-Review Stage

The pre-review stage begins once the ORRC is in receipt of the submission. The ORRC reviews the submission for completeness and ensures that the submission adheres to requirements of the Board and federal regulations. If any information is incorrect or incomplete, the PI will be notified and asked to make corrections. If the submission is complete, it will be assigned to a review process and to at least one IRB member (or ORRC staff member) for review. If the submission requires review by the full regulatory Board, the ORRC schedules the submission for review at the next available IRB meeting as indicated by the IRB submission and deadline schedule.

IRB Review Stage

The submission is reviewed by at least one IRB member. This review process can take up to 6 weeks

  • Exempt reviews may take up to 2 weeks
  • Expedited reviews may take up to 4 weeks. It is important to note that an “expedited” review is not a quicker review. It is merely a review process in which the study activity poses minimal risk to participants and does not require a review by the full board.
  • Full Board reviews may take up to 6 weeks
  • Reviews of submissions already approved by a central or single IRB and only require HU IRB approval for local context may take up to 1 week

Post-Review Stage

Once the regulatory compliance review is complete, an outcome letter will be sent to the study PI and authorized study personnel indicating that the submission was approved/accepted, disapproved/unaccepted, requires revisions, may be approved pending the administrative review of given conditions, or the review has been tabled for a given reason. Depending on the outcome, further information may be requested by the prior to the full approval of the submission.