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, at UNTHSC, all research projects involving human subjects must be reviewed by the OReC to determine if they are truly “exempt” or if they must be reviewed by the IRB. This EXEMPT category of review is conducted by OReC staff and verified by the Executive Director of OReC.
By providing complete and accurate information along with the Exempt Category Review form, investigator’s 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).