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What will happen after IRB review?

The IRB will provide you with a written decision within eIRB+ indicating that the IRB has approved the Human Research, requires modifications to secure approval, has deferred review of the submission, or has disapproved the Human Research.

• If the IRB has approved the Human Research: You may begin Human Research after you meet all other institutional approvals. IRB approval will usually be for a limited period, not more than one year from the approval date, for greater than minimal risk studies or, as noted in some minimal risk studies. The IRB provides the expiration date in the approval letter.
• If the IRB requires modifications to secure approval: Only address the required modifications from the determination letter and submit them in eIRB+ within 21 business days after receiving your determination letter. Do not add any new changes to the study submission at this stage. The IRB will issue a final approval when you have made all required modifications. You cannot commence research until this final approval is received. If you do not accept the modifications, provide justification in your response and submit it to the IRB. If you submit the required modifications to the IRB after 21 business days, it will be evaluated on a case-by-case basis if it needs to go to a convened meeting.
• If the IRB defers the Human Research: The IRB will provide a statement of the reasons for deferral and suggestions to make the study approvable and allow you to respond in writing. In most cases, if you address the IRB’s reasons for the deferral, the IRB can approve the Human Research.
• If the IRB disapproves the Human Research: The IRB will provide a statement of the reasons for disapproval and allow you to respond in writing.

If the IRB determines that your study does not meet the criteria for approval, the IRB Chair or IRB Vice-Chair may reach out to you to convey the IRB’s concerns. If you are unable to resolve the issues, you may request to attend the next panel meeting to discuss the IRB’s concerns and provide additional information that may assist in the review. The IRB Chair or IRB Vice-Chair may grant your request at their discretion.

If your submission does not move forward in the review process due to inactivity on your or your designee's part for 30 business days, the IRB Office may administratively discard the submission from the eIRB+ system.  Please communicate the status of any ongoing efforts to the IRB Office by writing a comment in the eIRB+ submission.