For researchers, understanding whether a protocol falls under expedited or exempt status can often be confusing. “Exemption” does not mean a project is exempt from evaluation: all human subjects studies, without exception, must be submitted to the IRB for a final status determination. This FAQ, however, will help investigators reflect on the distinction between expedited and exempt studies. The section “How does the IRB decide whether a project is expedited or exempt?” offers insight into the thought process the IRB might use when reviewing a study. The side by side chart gives a general comparison of expedited and exempt studies.
After reviewing the checklist and FAQ sheet, if you believe your study qualifies as exempt, please complete and submit the Application for Exemption from IRB Review. You do not need to complete CITI human subjects training to submit an application for exemption. However, if it is determined that your protocol needs a higher level of review, you will be required to complete a new protocol submission and include certification of CITI training. Exemption applications usually take no more than 2-3 business days to process and issue an exemption letter (unless it is determined that the study should be elevated to a higher level of review).
First, the IRB Administrator will look at the abstract and methodology and determine if the protocol submission meets the Federal definition of both “human subjects” and “research” (see SU IRB Policies and Procedures: Section I). If the study does not meet both definitions, the IRB will notify the researcher that the protocol is determined Not Human Subjects Research (NHSR), although the researcher may still be responsible for HIPPA, local regulations, and best ethical practices.
If the project meets both definitions, and involves data or specimens with no individual identifiers (see SU IRB Policies and Procedures: Appendix B) or no identifying link to participants available to the investigator, then these projects are also NHSR according to DHHS “Coded Specimen Guidance.” A letter to that effect is provided.
To qualify as exempt, research activities must (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 is still not eliminated, the next step is to see whether it fits one of the six exemption categories. Once a potential exemption category is determined, the following questions will be asked:
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.