Research Compliance Exempt Categories

Which Exempt Categories Apply to My Research? Ohio University IRB Guidance

Purpose

To ensure consistency in review for research conducted under exempt review, promote awareness in the Ohio University research community about what kinds of study procedures are and are not permitted under each exemption category

Scope

This guidance applies to all studies to be reviewed by an OU IRB.

Definitions

exempt human subjects research involves study procedures with individuals and/or their identifiable data that fits into one or more of the following categories. “Exempt” human subjects research is not equivalent to research that does not meet the federal definition of “human subjects research” at all. Complete protocols must be submitted in Cayuse for exempt research. At Ohio University, the Office of Research Compliance reviews exempt protocols, except for protocols that require a limited IRB review. The Office of Research Compliance, in consultation with the Ohio University IRBs as necessary, determines eligibility for exempt review. Researchers do not determine eligibility for exempt review.

Please refer to the federal regulations for official definitions of each of the exemption categories.

Category 1

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.

Examples:

  • A comparison of two different but commonly used phonics approaches in second grade
  • A study comparing college students’ knowledge of the Battle of Gettysburg before and after a lecture on the topic is delivered
  • A project seeking to understand the most effective way to organize space in a community cooking class to minimize liquid spills

Category 2

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 at least one of the following criteria is met:

  1. The information obtained is recorded by the investigator in such a manner that the identity of the Human Subjects cannot be readily ascertained, directly or indirectly through identifiers linked to the subjects; OR
  2. Any disclosure of Human Subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; OR
  3. The information obtained is recorded by the investigator in such a manner that the identity of the Human Subjects can be readily ascertained, directly or indirectly through identifiers linked to the subjects, AND an IRB conducts limited IRB review.

Examples:

  • An interview project asking people to discuss their experiences with historic preservation boards
  • A survey project investigating people’s preferences for one teleconferencing platform over another
  • A focus group study about perceptions of severe weather alerts

Notes:

  • Does not include surveys, interviews, or focus groups with minors that are not eligible for review under exemption category 1
  • Does not include deception research for survey projects
  • Does not include participant observation (in which researchers would interact with people) or observation of private behavior

Category 3:      

(i) 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 at least one of the following criteria is met:

(A) 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;

(B) Any disclosure of the human subjects? responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects? financial standing, employability, educational advancement, or reputation; or

(C) 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.

(ii) For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.

(iii) If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

Notes:

  • Does not include interviews
  • Does not include study procedures where the primary focus is physical activity or exercise
  • Study procedures must begin and complete within a 24-hour period and be no more than 4 hours in total

Category 4

Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

(i) The identifiable private information or identifiable biospecimens are publicly available;

(ii) 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;

(iii) 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); or

(iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.

Examples:

  • A project using consumer data legally collected for non-research purposes under a terms of use agreement, including identifiable data such as street addresses, given to a researcher by the company
  • A project analyzing biospecimens from an existing biospecimen repository
  • A project analyzing educational testing data from a K-12 school system, in which parents provided prospective permission for their children’s individual test scores to be analyzed for research purposes. The researcher does not recontact or reidentify the parents or the children.  The researcher does not record the testing data with any identifiers when they receive it.

Notes:

  • Only applies to the reuse of data and specimens that were or will be collected for non-research purposes or from research studies other than the proposed research study
  • Sub-category iv is not commonly used at Ohio University
  • Sub-category iii only applies to the use of data (when HIPAA applies) and notto biospecimens
  • No contact between a researcher and a subject who provided data is allowed

Category 5

this category is not commonly used at OU. Please consult with the  Office of Research Compliance before submitting under this category.

Category 6:  

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.

Notes:

  • Does not include the administration of dietary supplements
  • Does not include the administration of drugs or medications
  • Informed consent processes for category 6 studies should be crafted to give sufficient information to potential participants who might be allergic or have sensitivities to the food being studied. Potential contraindications with common medications should also be disclosed to participants.

Category 7

This category is not commonly used at OU. Please consult with the Office of Research Compliance before submitting under this category.

Category 8:

This category is not commonly used at OU. Please consult with the Office of Research Compliance before submitting under this category.

Revised: 10/10/2024

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