Criteria for IRB Determination of expedited review of future Continuing Reviews
Expedited Review Category (8):
Under Category (8), an expedited review procedure may be used for the continuing review of research previously approved by the convened IRB as follows:
(a) Where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; OR
(b) Where no subjects have been enrolled and no additional risks have been identified;
(c) Where the remaining research activities are limited to data analysis.
Of note, category (8) identifies three situations in which research that is greater than minimal risk and has been initially reviewed by a convened IRB may undergo subsequent continuing review by the expedited review procedure.
For a multi-center protocol, an expedited review procedure may be used by the IRB at a particular site whenever the conditions of category (8)(a), (b), or (c) are satisfied for that site. However, with respect to category 8(b), while the criterion that "no subjects have been enrolled" is interpreted to mean that no subjects have ever been enrolled at a particular site, the criterion that "no additional risks have been identified" is interpreted to mean that neither the investigator nor the IRB at a particular site has identified any additional risks from any site or other relevant source.
Expedited Review Category (9):
Under Category (9), an expedited review procedure may be used for continuing review of research not conducted under an investigational new drug application or investigational device exemption where categories (2) through (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
The determination that "no additional risks have been identified" does not need to be made by the convened IRB.
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.