Levels of Review
There are eight exemption categories recognized by the federal regulations (45 CFR 46). Research involving no more than minimal risk to participants, which do not collect easily identifiable information, and fit into one of the eight exemption categories can be reviewed at the exempt level of review. Projects categorized as exempt or exempt with limited review are reviewed by the director of the Institutional Review Board. Please note that research studies involving medical treatments of any kind cannot fall under exempt review.
Research projects that qualify for expedited review fall into one of nine expedited categories recognized by federal guidance. Expedited research cannot present more than minimal risk to participants. This review level is called "expedited" because one or two IRB members or the IRB chair may review the application rather than the full board. One of the major differences between exempt and expedited review is that researchers may collect identifiable information at the expedited level. Any research intending to collect sensitive information or data which may cause harm to participant employability, reputation, or social status requires review by the full board.
Any project not categorized as exempt or expedited review requires full board review. Review by the fully convened board takes place at an Institutional Review Board meeting (a quorum, or majority, of the board must be present for the meeting to commence). Research involving greater than minimal or significant risk to participants or any research involving vulnerable populations must be reviewed by the full board. Vulnerable populations include children (in Minnesota, minors are individuals under the age of 18), pregnant women, prisoners or other incarcerated individuals, economically or educationally disadvantaged individuals, or individuals without the capacity to consent to participate in research. Any medical treatments for research beyond what is allowed at the expedited level require full review.