Approval Timelines and IRB Process

  1. Complete CITI: https://www.kent.edu/research/office-research-compliance/compliance-training
  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 
  4. 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. Kuali IRB E-Protocol
  5. Completes and submits the application after ensuring appendices and any other supplemental materials, including recruitment and consent materials are complete and accurate.
    1. Plan for the review process to take up to 8 weeks.
    2. "Legacy" projects are those that were approved prior to the implementation of Kuali. "Legacy" continuing reviews, amendments, and adverse/noncompliance events can be submitted to researchcompliance@kent.edu.
  6. The Office of Research Compliance administrates the review. 
    1. Level III projects are assigned to an agenda and the PI is invited to attend the meeting.        
      •  ​​​​​​​Requests for Level III review must be received by the ORC from a reviewer no later than 10 working days before an IRB meeting for inclusion. We cannot guarantee review by a particular committee.
      • Comments are typically released within 3 working days of the meeting. 
    2. Level II projects are reviewed by one IRB member and the IRB Chair.
      • ​​​​​​​Comments are typically released after Chair review.
    3. Most Level I projects are reviewed by one IRB member. 
      • ​​​​​​​Comments are typically released after member review.
    4. Some reviews may require a dynamic process that requires a deviation from steps 6.1-3.
  7. Address comments, if any, to for a final IRB determinations. This step may require back and forth.   
  8. Important notes:   
    1. If you are a student, your faculty advisor must review your application prior to submission - they are the PI and only the PI can submit via Kuali.
    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 by the number of submissions received. 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.

 

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