Some studies that are “minimal risk” may qualify for EXEMPT category status. These studies have features and procedures that are specifically described by the federal regulations as “exempt” from IRB review. [Click here for descriptions and definitions of what research qualifies as an “exempt” category project].
Recall that all research projects involving human subjects must be reviewed by the North Texas Regional IRB to determine if they are truly “exempt” or if they require additional review and monitoring by the IRB.
By providing complete and accurate information along with the Exempt Category Review form, investigators can obtain effective review and approval within a few days (often sooner).
All EXEMPT category projects are then reported to the full IRB at their next convened meeting for their acceptance and approval as Exempt category projects.
Note that EXEMPT category projects do not need continuing IRB review and do not need any annual reporting (see below for brief overview of Continuing Review).
This page was last modified on December 21, 2017