Institutional Review Board

EXPEDITED RESEARCH PROTOCOLS


Research activities that present no more than minimal risk to human subjects may be reviewed by the IRB through the Expedited Review Procedure authorized by 45 CFR 46.110 and 21 CFR 56.110.

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45.CFR.46.102(j))(Common Rule).

To be eligible for expedited review, the research activities must be limited to those described in one or more of nine (9) federally-defined Expedited Review Categories. The activities listed in these categories should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.


Applicability of Expedited Review Categories


Expedited Review Procedure

The requirements for review of research using expedited procedures are identical to review by the convened board with two exceptions:

How to Submit

Submit a new protocol in Kuali Research and select Expedited Research under “Protocol Type.” The IRB Chair or designee will determine if the research qualifies for expedited review. Additional instructions for submitting a study for review by the expedited procedure are available in the Kuali Quick Guide - Expedited / Full Board Research.


Resources

Use the following resources (as applicable) to submit an initial application for a study that meets the regulatory criteria for expedited research: 

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