Tips for Graduate Students - IRB Approval process

IRB Approval for research involving human subjects is required before conducting research.  Documentation of IRB approval must be submitted to the graduate school with the student's thesis or dissertation. 

Steps to obtaining IRB Approval:

Presubmission process:

• Discuss your project with your advisor/PI.  Obtain approval from your graduate committee prior to submitting to the IRB.
• Set up your Novelution profile by logging in at erac.ndsu.edu.
• Take required appropriate CITI training.
• All members of the research team including the PI, Co-investigators, and other team members must also have completed required CITI training within the last three (3) years.
• Submit IRB protocol for review. 
  • IRB review timelines vary from a matter of days (average of 5-7 business days for Exempt protocols) to weeks (for Expedited reviews) to months (if Full Review is required).  Ensure that you have planned for enough time to navigate the IRB review process and still conduct the proposed study prior to your anticipated date of graduation.
• If the protocol is submitted by a graduate student, the PI/Advisor is automatically notified that the protocol has been submitted on their behalf.  The PI/Advisor must approve the submission.
• Following PI approval, the department chair/head must also approve the protocol submission.

Postsubmission process:

• Once the Protocol has been submitted and received departmental approval, the protocol is now Ready for the IRB review process.
• Protocol submissions are processed in the order they are received, and may take a few days for the initial review to occur.
• The IRB Administrator will determine if the protocol can be reviewed via Exempt procedures, or if assignment to Expedited or Full Review procedures is required.  You may receive requests for clarifications and/or revisions along the way. PIs, Co-PIs and other team members with Edit access to the protocol receive an auto-generated email when revisions have been requested.  Use the link in the email to Log into Novelution and view requested revisions in the Review Comments panel.
• Comments/Questions may require updates to the protocol, submitted attachments, or in some cases questions may be answered in the Comment bubbles found next to the Review Comment.  Once ALL comments/questions have been addressed, the protocol must be resubmitted for further review.
• Protocols may go through multiple rounds of revisions so be sure to plan for enough time to secure IRB approval prior to beginning your research.
• Once final approval is granted, the PI, Co-PI and any team members with Edit access will receive an approval letter via email.  The Approval letter is stored in the IRB Correspondence section and can be accessed at a later date when requested by the Graduate School.