APPROVED: No changes are required.
An IRB action taken when the required determinations are made that allows research involving human subjects to
proceed consistent with federal regulations, state and local laws, and University policy.
CONTIGENTLY APPROVED: Minor, specific, non-substantial changes are required.
An IRB action that specifies conditions under which research can be approved. Comment by IRB members must be
directive requesting simple concurrences or specific, non-substantive changes.
Upon receipt of the required changes, the IRB Chair or another member designated by the Chair will verify that the
appropriate additions/corrections were made and will either approve the study or return it to the Full Board for further
review at a convened meeting.
DEFERRED: Substantial modifications and/or additional information are required.
An IRB action taken when the convened IRB cannot fully evaluate the research under review and make the
determinations required for IRB approval without modifications to the Application and/or informed consent
document(s), or submission of clarifications or additional materials prior to reconsideration of the research.
Deferring a submission requires that the entire study with the additional information or modifications be reviewed by
the Full Board at a convened meeting.
DISAPPROVED: Criteria for IRB approval are not met.
An IRB action taken when the determinations required for approval of research cannot be made, even with substantive
clarifications or modifications to the Application and/or informed consent process/document(s). Only the Full Board may
disapprove a study.
TABLED: Criteria for a convened Full Board meeting are not met.
An IRB action that indicates that review was not initiated or was not completed, resulting in postponement of IRB
review, usually due to loss of quorum or other administrative issue. Research tabled at a convened meeting will be
reviewed at the next convened meeting.
EXPEDITED CATEGORY #9: Criteria for continuing review of research by a convened Full Board that no longer involves greater than minimal risk.
An IRB action on continuing review of research, not conducted under an investigational new drug application or
investigational device exemption, where Expedited categories two (2) through eight (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.