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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 meets the requirements for one of the exempt categories of review. 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 46.104. 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 Protocol Form is required 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 granting approval at one of the exempt categories.