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 submitted, your submission will be assigned to the HRPP coordinator assigned to your department. The submission will undergo a pre-review. The coordinator will ensure that the application is complete and in keeping with the IRB’s requirements. You may be asked to make changes to the application and study documents during this time. This phase may take several rounds.

Once the coordinator has determined that the submission is complete, it will be routed for Exempt, Expedited or Full Board Review.

2.       Review Type

Non-Committee Review (Exempt or Expedited)

  • Exempt Determination: If the study poses little to no risks and fits in one of the exempt categories, the submission is reviewed by the HRPP staff for an Exempt Determination.
  • Expedited Review:
    • If the study doesn't meet the criteria for an exempt determination and poses minimal risks, the submission is sent to one IRB member for review via expedited procedure.
    • The IRB reviewer will ensure that the criteria for approval are met (HRP-314 Criteria for Approval)
    • The study investigator may be asked to make additional changes to secure approval.

 

If the study presents more than minimal risks to participants, or if the HRPP staff and/or the IRB reviewer determine that the study does not qualify for Exempt or Expedited Review, the study will be referred to the 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 review board convenes once a month, typically on the first Wednesday of each month.
  • The study will receive one of the following outcome by the IRB:
    • Approval
    • Modifications 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?