The Application Process
An investigator should apply to the IRB as soon as they have a clear picture of the project they intend to conduct, but before they initiate any part of the project- including subject recruitment. The IRB accepts and reviews projects that are no greater than minimal risk on a rolling basis- except during semester breaks and the month of August. Projects that are greater than minimal risk will be accepted on a rolling basis, but will only be reviewed at a scheduled convened meeting (also known as a full board review),for which all project materials have been received by the appropriate deadline and there is sufficient room on the agenda. The full board does not convene during summer months (i.e., June, July, August).
There are a number of factors to consider when determining how long the review process may take. Such factors may include: if the project request is complete; the level of risk- as determined by the IRB; the workload of the IRB at the time the request is received; the length of time investigators take to respond to any stipulations/ conditions/ contingencies or modifications required by the IRB; and -- if the project presents greater than minimal risk-- when the next convened meeting is scheduled. You will be able to monitor the status of your submitted materials through the IRBManager system.
- If the IRB’s workload is manageable, the project presents no greater than minimal risk, and the project request is complete, an investigator may expect to receive a notification* via email about the review outcome within 8-10 business days from the time a project is received by the IRB for review.
- If the project is greater than minimal risk (as determined by the IRB), a complete request is received by the meeting deadline, and the IRB does not have a full agenda for the next meeting, an investigator should expect to receive notification* via email about the review outcome within 2-3 business days from the scheduled review (i.e., the convened meeting at which the board will review the project).
*This notification may not indicate the last step in the review process, but rather the estimated turn- around time from receiving the submitted request or scheduled full board review until an initial (and sometimes final) outcome can be made.
A notification will inform the investigator of the action the IRB has taken during the review process and any stipulations/conditions/contingencies or modifications required or, if approved, the expiration date and terms of approval (e.g., complying with amendment(s), continuing review and study closure report submissions). The IRB may make one of the following determinations:
- The project does not meet the definition of human subject research.
- Approved with conditions/ contingencies (this does not constitute final approval).
- Tabled/Deferred (modifications may possibly be requested).
- Suspended (indefinitely or until identified concerns are addressed).
If the notification states any outcome, other than “Approved,” the investigators may not initiate the project. “Approved with conditions/ contingencies” does not mean the project is approved, but rather conditions/ contingencies must be submitted, reviewed, and approved by the IRB prior to initiating the project.
In the event a review results in modifications, the IRB requests such to be submitted within 30 days from the date of the notification. Likewise, if a review results in a suspension or disapproval and the investigator wishes to appeal the decision, a written request must be received within 30 days from the notification.
*A project may only be disapproved at a convened full board meeting.
Follow the Instructions to Submit to the IRB. Locate and follow the relevant instructions (i.e., initial, amendment, continuing review, key personnel change, study closure report, unanticipated problem/ violation report, faculty advisor training submission) on that page.
Most approvals expire 1 year from the date of approval, but may be shorter depending on the degree of risk associated with the project and compliance history with the IRB policies and procedures. The approval period will expire at midnight on the expiration date. The expiration date will be on the approval letter and may also be found in the IRBManager system under the relevant project. Research may not be conducted beyond the expiration date without obtaining continuing approval [through the continuing review process]. If the project is complete and approval is no longer needed, investigators are required to submit a study closeout report on or before midnight of the date of expiration.