IRB Review Levels
There are three IRB review levels: Exempt, Expedited and Full Board
The research activity is initially assessed to determine the risk level. Minimal risk is defined as the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the routine performance of physical or psychological examinations or tests. If a study is determined to be minimal risk, it may qualify for:
Exemption - All aspects of the study must fit in one or more of these exempt categories [PDF]. Exempt determinations may be granted by the Office of Research Compliance (ORC). Submissions meeting exempt criteria are reviewed on a rolling basis.
Expedited Review - Studies must fit in one or more of these expedited categories. Expedited reviews are assigned to one or more IRB members on a rolling basis.
Turnaround times for exempt and expedited submissions vary depending on the completeness of the submission, the number of rounds of revisions needed, and overall submission volume in our office. ORC staff will conduct a pre-review of your submission to ensure clarity and completeness before forwarding for IRB review. On average, ORC pre-review will occur within 1-3 business days, and IRB review will occur within 5 business days of the IRB reviewer receiving the assignment. ORC will process the IRB member’s review within 1-2 business days upon which the study may be approved or returned to the corresponding investigator (CI) for revisions. Therefore, we suggest planning for a minimum of 2 weeks for each round of review when developing your research timeline. This timeline may be extended during times of high submission volume.
If a study is determined to be greater than minimal risk, or if all aspects of the study do not meet the criteria for an exempt or expedited category, it must undergo:
Full Board Review - A submission is placed on the agenda based on the date it is received by the Office of Research Compliance. The meeting dates and submission deadlines are posted here. The submission is forwarded to all IRB members on the board for pre-review. Approximately one week later, questions or required changes are sent back to the study team. Once the corresponding investigator (CI) submits a revised study, it will then be reviewed by the board in the monthly convened meeting. Following the convened meeting, any questions or required changes are sent back to the study team, typically within a few business days. Once the CI submits a revised study, it is again reviewed. In some cases, substantive revisions will need to be reviewed again by the full IRB at a subsequent meeting, but most revised submissions are reviewed by one or more IRB members within approximately 5 business days of resubmission.
Amendments – amendments to exempt and expedited studies are reviewed similarly to new studies in those categories.
Minor amendments to full board studies may qualify for expedited review, provided the changes do not impact risk to subjects or substantively change the study design. Otherwise, amendments to full board studies will be reviewed at a full board meeting.
Periodic Reviews – periodic reviews of expedited studies are reviewed by one or more IRB members on a rolling basis. Periodic reviews of full board studies are reviewed via the full board process above and must be submitted by the deadline for a meeting date prior to the study expiration date.
Please note – a submission does not get routed to ORC for processing in LEO until all members of the research team have signed off.