Step 4: What happens to my application once submitted?

Once your application is submitted and it has received its unique IRB number, the IRB Review Process begins.

1.       Pre-Review

Once your application is submitted, the submission will undergo a pre-review by an HRPP coordinator. The coordinator will ensure that the application is complete and in keeping with the IRB’s requirements. The investigator may be asked to make changes to the application and study documents during this time. Once the coordinator has determined that the submission is complete, it will be routed for Exempt, Expedited or Full Board Review.

2.       Review

Non-Committee Review

    • If the study poses little to no risks and fits in any of the exempt category, the submission is reviewed by the HRPP staff for an Exempt Determination.
    • If the study doesn’t fit in any of the exempt category and poses minimal risks, the submission is sent to one IRB member for review via expedited procedure.
    • The study may be approved or the investigator may be asked to make some changes to secure approval.

     

    If the HRPP staff or the IRB reviewer determine that the study does not qualify for Exempt or Expedited Review, the study will be referred to convened board for Full Board Review.

    Full Board Review

      • The submission will be assigned to two IRB members for review.
      • If the reviewers have questions, concerns or edits, they will be relayed to the research team in advance of the meeting (as time allows).
      • The project will be presented at a convened IRB meeting.
      • The study will receive one of the following determinations by the IRB: ApprovalModifications required to Secure Approval, Deferred (the application lacks information or significant details) or Disapproved (the study does not meet the criteria for approval).

       

      3.     Post Review

      • The Review outcome will be communicated to the investigator via iRIS.
      • If modifications or clarifications are requested, the application will be sent back to the investigators to revise and the process will start over. The revised application will be reassessed but the HRPP coordinator and then routed back to the original reviewer. 
      • When the study is approved, an approval letter with a list of approved study materials and stamped consent forms (when applicable) will be sent to the investigator via iRIS.
      • Approved documents will be noted as such in iRIS and downloadable.

       

      Next Step: I am approved, now what?