Exempt From Review
Research may be exempt from review when human participants conform to one of the categories from section 46.101(b) of 45 CFR 46. Research may qualify for Exempt status if it involves very minimal or no risk. Projects will not be given Exempt status if they include any degree of deception, involve more than very minimal risk to participants, involve sensitive information, or include protected classes or vulnerable populations. Please note that researchers must always engage in practices that ensure privacy and that minimize the risks to participants, regardless of the level of review. All of the rights and protections afforded to human subjects in research are required in Exempt status cases. If you believe that your proposed research qualifies for Exempt status, submit a Request for Exemption.
Expedited review involves a review of a proposal by a subset of the IRB that includes the Chair and at least one other board member. Expedited review does not mean a quick review; the IRB determined whether a project requires expedited or full review. A proposal that does not fulfill the criteria for Exempt status may undergo an Expedited review if it involves no more than minimal risk to the participants and meets other standards, such as not including protected classes or vulnerable populations, and not using intentional deception. Expedited review may also be used when minor changes are proposed to an approved research project during the period for which approval is authorized.
Any proposed research not qualifying for Exempt status or Expedited review requires a Full Review, in which a majority of IRB members review and vote on the proposal. These typically involve projects that place human subjects at more than minimal risk, or that involve sensitive topics or vulnerable populations such as prisoners, terminally ill patients, children, veterans, or cognitively impaired persons.