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Exempt Review Categories

In order to be classified as exempt, studies must fit into one of the categories below and cannot involve more than minimal risk. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Exempt does not mean that your research does not require review by the IRB. Exempt is a level of IRB review determined by the federal regulations governing human subjects research. Investigators are not allowed to make their own determinations regarding whether their research is exempt.

Currently, the University of Tennessee, Knoxville does not plan to use the Revised Common Rule Exempt Categories 7 or 8.

Can vulnerable populations be included in exempt research? Exempt studies cannot include prisoners unless the research is aimed at involving a broader subject population that only incidentally includes prisoners.

Exemptions 2(i) and (ii) for research involving survey or interview procedures or observations of public behavior do NOT apply to research in children, except for research involving observations of public behavior when the investigator does not participate in the activities being observed. Exemption 2(iii), where identifiable information is obtained and the IRB conducts a limited IRB review, is NOT applicable to research involving children. Exemption 3 does NOT apply to research involving children.

What is limited IRB review? The Revised Common Rule allows for a new category of review called limited IRB review. This level of review applies to four exempt categories in which participants’ identifiable information or biospecimens are collected for research. Studies that fit into these categories must still be minimal risk studies, with the primary risk to participants being the risk of harm to participants from the loss of confidentiality of their personal information. For these studies, the IRB must conduct a limited IRB review to ensure that there are adequate protections for participant privacy and confidentiality.

Human Subject Regulations Decision Chart

Exempt Categories

Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if the information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects.

Category 2 with limited IRB review: Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if the information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by .111(a)(7).

Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and the information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects.

Category 3 with limited IRB review: Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and the information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by .111(a)(7).

Category 4i: Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if the identifiable private information or identifiable biospecimens are publicly available.

Category 4ii: Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects.

Category 4iii: The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b).

Taste and food quality evaluation and consumer acceptance studies: (i) If wholesome foods without additives are consumed, or (ii) If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

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