Understanding whether a protocol may qualify for exempt status can often be confusing. “Exemption” does not mean a project is exempt from IRB evaluation: all studies involving human subjects must be submitted to the IRB for a final status determination. The section “How does the IRB decide whether a project is expedited or exempt?” offers insight into how the IRB might evaluate a study's risk level. At any point, feel free to email firstname.lastname@example.org for guidance in determining which application form to submit.
After reviewing the information below, if you believe your study qualifies as exempt, please complete and submit the Application for Exemption from IRB Review. You do not need to submit CITI human subjects training with exemption applications. (However, if your protocol needs a higher level of review, you will be required to complete a new protocol submission and include CITI certification.) Exemption applications usually take 3-4 business days to process and issue an exemption letter (unless the study needs elevation to a higher review level).
The IRB first determines whether the study meets Federal definitions of “human subjects research" and whether any risks may exist in the data collection process (regardless of intention to present or publish). If the study poses no risk to participants and does not meet definitions of human subjects research, the IRB will issue a determination of "Not Human Subjects Research (NHSR)." (The researcher may still be responsible for HIPPA, local regulations, and best ethical practices.)
The IRB may determine a project to be "exempt" from higher IRB review if the study meets human research definitions and research activities (1) present no more than minimal privacy, psychological, and/or physical risk to human subjects, and (2) involve only procedures listed in one or more of the following categories:
If a project fits within a potential exemption category above, the IRB will then consider the following questions:
If the answer to any of these questions is YES, or if the project does not appear to fit any exempt category, it will be processed as expedited or full board.