Approval Timelines and IRB Process

Getting Started

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. Training is considered an ongoing process. 
3. Plan for the review process to take up to 8 weeks. Review timelines are affected by total submission volume, see the chart below. 
4. Collaborate with your team to determine who will write the application and respond to any IRB comments 

Preparing the IRB application

1. Reviews common mistakes and questions document and Information on levels of review
   1. Applications with significant writing concerns will not reviewed until the concerns have been addressed (see common mistakes and questions).
   2. Anyone conducting exempt research should review the IRB Guidance on Exempt Research
2. Completes and submits the application after ensuring appendices and any other supplemental materials, including recruitment and consent materials are complete and accurate.

IRB review 

1. The ORC conducts a prereview and distributes the application as noted below.
2. 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. 
   • PIs are invited to attend the meeting and should forward the invite to any other research team member that should be present. 
     • The researchers are asked to provide a very brief overview of the study and answer questions.  
3. Level II projects are reviewed by one IRB member and then the IRB Chair.
   • ​​​​​​​Comments are typically released after Chair review.
4. Most Level I projects are reviewed by one IRB member. 
   • ​​​​​​​Comments are typically released after member review.
5. A small number of reviews may require a dynamic process that requires a deviates from the process.
6. Address comments, if any, to secure an IRB determination. This step may require back and forth.   

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 (see IRB Help Section 6 and 3) or are conducted in international settings (see IRB Help Section 8 - 8.14) take longer to review (common comments).
   1. HIPAA review occurs 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.

Post approval

1. File amendment, continuing review, and event reports as needed, see the IRB help page for more details.
2. Use the Self Assessment Tool regularly to check-in and evaluate the completeness of your records.
3. Practice data stewardship by deidentifying information as soon as allowed by the research. Remove access from those that leave the study.
4. File Close Out requests once all participant intervention and interactions are complete, including long term follow-up, and the data is deidentified.