Criteria for IRB Determination of More than Annual Review
Except for studies determined to be exempt from IRB oversight, all human subjects studies are subject to continuing review based on the level of risk as assessed by the board.
- This review takes place at a minimum annually, and may require more frequent review or reports as determined by the UI IRB.
- The length of approval is calculated from the date of the convened meeting at which the IRBs approve the protocol or approve the research with modifications.
- The appropriate length of approval should be considered as part of the full board discussion on both initial and continuing reviews.
- Examples of when the IRB might consider requiring review more frequently than annually may include:
- Experimental therapies in which the clear potential for significant adverse experiences have been identified at the time of review;
- Non-therapeutic projects based on risk information provided at the time of initial review;
- Projects in which new information provided during the duration of the study (including at the time of continuing review) indicates a high probability of significant adverse experiences not previously reported;
- Projects in which local or outside adverse experience reports create new concerns regarding the need for closer project scrutiny;
- Projects where the UI IRB has concerns with regard to previous or potential serious or continuing noncompliance; or
- Other, as determined by the convened IRB.
In such cases, the IRB may consider granting approval:
- for time periods less than one year, or
- for a limited number of subjects over a period not to exceed one year, or
- with additional monitoring as a requirement.