Other studies that are “minimal risk“, but that do not meet the strict criteria for EXEMPT category must be reviewed by the IRB.
However, the regulations allow for such minimal-risk studies to be reviewed at an “expedited” level, in which only the IRB Chair, or an IRB member designated by the Chair, may review and approve the project. Federal regulations allow for such reviews for a wide-range of specifically defined studies with certain features. [Click here for descriptions and definitions of what research can be reviewed at an “Expedited” level].
As with Exempt category projects, an Expedited review is initially conducted by an OReC staff member and then verified by the Executive Director of OReC. However, at this level, the IRB Chair (or IRB member designee) must also review and approve the project. By providing complete and accurate information along with the Expedited Category Review form, investigators can obtain an effective and timely review and approval within a few days, depending on the complexity of the project and proper documentation provided by the investigator. An incomplete application or protocol with concerns that need to be addressed will extend the time period before final approval can be authorized.
All EXPEDITED category projects are then reported to the full IRB at their next convened meeting for their acceptance and approval as Expedited category projects. However, because of the increased level of risk and complexity that might be involved with such projects, any IRB member, at any time, can ask that a protocol which was approved on an Expedited basis be brought back to the full IRB for further review and consideration at the next convened meeting.