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An Exempt Form is submitted for research involving human subjects, including data or tissues derived from humans, when the investigator believes the research may be exempt from the federal regulations at 45 CFR 46 and continuing IRB oversight. To be eligible for an exemption determination, activities involving human subjects must be limited to one or more of the categories for exemption at 45 CFR 46.101(b) [38 CFR 16.102(b)]. A proposal is not eligible for a claim of exemption if the research is greater than minimal risk, FDA regulated (except for category 6), involves deception, or involves prisoners.
If at any time in the process of completing the exempt form, you determine that the research does not meet the requirements for exemption, please STOP and use:
- the Determination of Human Subjects Research checklist if the research does not represent Human Subject Research, or
- the initial Social and Behavioral Sciences or Health and Biological Sciences Application form if the research requires expedited or convened (full) IRB review.
Note: Research may not begin; including initiating recruitment, voluntary informed consent, or collecting data on potential subjects, until you receive a written letter from OPRS approving the claim of exemption.