Now that you have determined that your study meets the definition of "human subject research" as defined in Step 1, you must submit for COMIRB review. You must also decide which type of review is most appropriate.
The potential level of risk to the subjects of a study determines the level of oversight by COMIRB. The three levels of oversight defined in federal regulation 45 CFR 46 are determined by the relative risk of the study to subjects. These levels of oversight are: Exempt review, Expedited review, and Full Board review.
Studies that are of "minimal risk" to subjects as defined in the federal regulations can be exempted all together from the federal rules governing "human subject research", provided that they fall into one of the 5 "Exempt Categories" outlined in the federal regulations. COMIRB must grant the exemption; investigators cannot exempt their own research.
Other studies that are considered "minimal risk", but do not qualify for one of the 5 "Exempt Categories", are subject to the federal rules governing "human subject research".
If your study does not qualify for an exemption from federal regulations, it may qualify for Expedited review provided that it fits into one of 7 "Expedited Categories". You will learn more about Expedited reviews in Step 3. All research that is considered more than "minimal risk" must be reviewed by a Full Board panel. You will learn about Full Board reviews in Step 4.
The accordion folders below will help you determine if your study is "minimal risk", and if your study falls into any of the 5 "Exempt Categories".
Please be aware that there are limitations to Exempt review if your study includes potentially vulnerable populations whose status may create additional risk for study participation, including children and prisoners. *Studies involving prisoners cannot qualify for an exemption.