Introduction to Exempt Review

  • The Code of Federal Regulations identifies several different categories of minimal risk research as being exempt from Federal Policy for the Protection of Human Research Subjects.  This does not mean that they are exempt from IRB review.
  • The IRB does not "approve" an exempt study but instead makes a determination that the project meets at least one of the federal exempt categories criteria.
  • Prior scientific review by a School or Departmental review committee is not required.
  • No annual continuing review is required and no expiration date will be listed on your approval letter.
  • Amendments are required only if the changes to the project would alter the exemption criteria. 

Exempt Categories

The IRB has developed guidance and application forms for the most commonly requested exemptions. You will be required to download one of the exempt protocols, save to your computer, complete and then upload the form on the Basic Information page.  If no template is available for your category, please check the templates page for a protocol that most suits your study

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  • Educational Research (Strategies, Curricula, or Classroom Management Methods)

    Research, conducted in established or commonly accepted educational settings that specifically involves normal educational practices. This exemption 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.

    Both must be true:

    • The research is not likely to adversely impact students’ opportunity to learn required educational content
    • The research is not likely to adversely impact the assessment of educators who provide instruction

  • Tests, Surveys, Interviews, or Observations of Public Behavior

    Research that includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording).

    All must be true:

    • This research does not include children as defined by 45 CFR 46.402(a)
    • This research is not subject to regulation by DHHS, Dept. of Defense (DOD), Dept. of Education (ED), Environmental Protection Agency (EPA), or Veterans Administration (VA), US Department of Agriculture (USDA)
    • The procedures are limited to (1) the observation of public behavior when the investigator(s) do not participate    in the activities being observed’ and/or (2) the use of educational tests

  • Research involving Benign Behavioral Interventions

    Research involving benign behavioral interventions[1] in conjunction with the collection of information from a subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection.

    [1] 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.

  • Secondary Research with Data and/or Specimens

    Secondary research uses of identifiable private information or identifiable biospecimens (for which consent is not required)

    At least one of the following must be checked to qualify for this exemption:

    • The identifiable private information/biospecimens are publicly available.
    • Or; Information is recorded by the investigator in such a manner that:
      • The identity of the 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 

  • Research & Demonstration Projects Conducted or Supported by a Federal Department or Agency

    Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads or designee that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. The research or demonstration project is published on the department or agency’s list of research and demonstration projects that the department or agency conducts or supports under this provision.

  • Taste and food quality evaluation & consumer acceptance studies

    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 Dept. of Agriculture.

    At least one of the following must be checked to qualify for this exemption:

    • The food contains only food ingredients at or below the level and for a use found to be safe
    • The food contains agricultural chemical or environmental contaminants 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 Dept. of Agriculture.