Office of Research Compliance

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 - Studies must fit in one or more of these categories. Determination of exemption is processed by the Office of Research Compliance.  The processing time for exempt determinations ranges from 0 days to 87 days, with the average turnaround time of 7.2 days.

OR

Expedited Review - Studies must fit in one or more of these categories.  Expedited reviews are conducted by a sub-committee of the IRB.  The processing time for expedited reviews ranges from 1 day to 146 days, with the average turnaround time of 25.7 days.

If a study is determined to be greater than minimal risk, 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 days.  Once the corresponding investigator (CI) submits a revised study, it is again reviewed.  The processing time for full board reviews ranges from 19 days to 140 days, with the average turnaround time of 46.6 days.