Levels of Review
There are six exemption categories recognized by the federal regulations (45 CFR 46). Research projects involving no more than minimal risk to participants and do not collect private, identifiable information are often reviewed at the exempt level because it falls into one of these categories. Exempt review means that the project can be reviewed by the director of the Institutional Review Board as it is exempt from review by other board members or the full 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 private, identifiable information at the expedited level. However, if any identifying information would cause harm to participant employability, reputation, or social status then the research must be reviewed by the full board.
Any review that does not fall under exempt or expedited levels of 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). Full review includes research involving greater than minimal or significant risk to participants or any research involving vulnerable populations. Vulnerable populations include children, pregnant women, prisoners, 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.