IRB must review all projects that meet the definition of research and that involve human subjects prior to any data collection to determine the appropriate level of review, and, as appropriate, approve them. There are three major types of review: Exempt, Expedited, and Full.
Studies that receive an exemption determination from IRB are exempt from the specific regulations and requirements in Title 45, Part 46 of the Code of Federal Regulations. Please note, however, that they are still considered human subject research.
If the proposed research involves no greater than minimal risk to participants and involves any of the following, it may qualify for exempt status in accordance with the revised Common Rule (effective January 21, 2019):
Studies that involve no more than minimal risk but which do not meet any of the above criteria for exempt status may be eligible for Expedited Review. According to the CFR, “minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”
If the proposed research presents no more than minimal risk, does not involve any vulnerable populations (i.e., children, prisoners, individuals with impaired decision-making capacity, and/or economically or educationally disadvantaged persons), and involves any of the following, it may qualify for Expedited Review.
If the proposed research does not qualify for Exempt or Expedited Review as defined above, it will be subject to a Full Review. In addition, if the proposed research involves any of the following, it will be subject to Full Review.
Protocols requiring Full Review are vetted by the entire IRB and discussed at a convened meeting. Please see our Timing of the IRB Process web page for submission deadlines and meeting dates for Full Review protocols.
If you have questions about what type of review may be appropriate, contact the Chair of IRB at email@example.com prior to submitting a proposal. IRB, however, makes all final determinations of what level of review is required.