Approval Timelines and IRB Process

  1. Complete CITI:
  2. Complete any project or lab specific training. If training needs to occur opportunistically during the study, ensure personnel are properly overseen.
  3. Reviews common mistakes and questions document and Information on levels of review then Selects the application to complete:
    1. Exemption Self-Determination, use this application for most Level I (exempt) Category 1 and 2 research (Tip, review the IRB Guidance on Exempt Research)
    2. Level I exemption application, use this application if your study is exempt and does not qualify for Exemption Self-Determination
    3. Level II/III application, use this application for all non-exempt research
  4. Completes the application and ensures appendices and any other supplemental materials, including recruitment and consent materials are complete and accurate.
  5. Send completed materials to the appropriate discipline specific reviewer.
    1. Plan for the review process to take up to 8 weeks.
    2. Annual reviews, amendments, and adverse/noncompliance events can be submitted to
    3. IMPORTANT! All CPM submissions must be made to Jill Kawalec
  6. Work with reviewer to address any actionable items.
  7. Reviewer sends complete review to Office of Research Compliance.
    1. Level III project go onto an agenda PI is invited to attend the meeting.
      1. Application for level III review must be received by the ORC from a discipline specific reviewer no later than 10 working days before an IRB meeting for inclusion. We cannot guarantee review by a particular committee.
    2. Level II projects are triaged by ORC and forwarded to IRB Chair for approval/comments.
    3. Most Level I projects are directly approved by the reviewer. Projects that involve research in international settings, involve HIPAA compliance, receive external research funds, or involve “engaged” external collaborators are subject to final review by ORC, or in limited circumstances the IRB Chair
  8. Important notes:  
    1. If you are a student, your faculty advisor must review your application prior to submission - they are the PI.
    2. Projects that involve FERPA or HIPAA compliance or conducted in international settings may take longer to review.
      1. All projects that are subject to HIPAA regulations must be reviewed by the Privacy Board prior to approval. The Privacy Board meets on the third Thursday of each month.
    3. Protocols that are highly complex or incomplete take longer to review.  
    4. Approval timelines are affected the number of submissions receive See the chart below.
The chart describes the volume of IRB submission received each month. High volume months are February, March, April, October, and November. Medium volume months are September, January and May. The remaining months are lower volume.