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Categories of Exempt Research

If your research involves minimal risk and falls under one of the categories below, please submit an Exemption Request. The application is a brief short-answer form and you do not need to complete the CITI Training to apply.

The exemption categories below are also listed on the Exemption Request form so you can refer to them when completing the application.

An approved Exemption Request is required for your exemption to be confirmed and granted by the IRB. The authority to determine and confirm exempt status rests with the IRB and the ORC and not with the faculty, staff, or student performing the research.

Exemption means only that the project doesn't require IRB review. It does not negate the need for the consent of subjects where applicable.

Category 1: Investigational Strategies in Educational Setting

Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:

  • research on regular and special education instructional strategies, or
  • research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Note: This category may be applied to research involving children.

Examples of exempt research:

  • Evaluating the use of accepted or revised standardized tests
  • Testing or comparing a curriculum or lesson
  •  Evaluation of continuing education

Does not apply to research on experimental practices or curricula, or techniques that those in the field would not recognize as standard or common. Education setting means college, university, elementary, secondary, or post-secondary school, or other setting or place in which the conduct of educational practices commonly occurs.

Category 2: Surveys/Interviews, Standard Educational Tests, Observations of Public Behavior

Research involving the use of anonymous educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:

  • information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
  • any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

The section of this category pertaining to standardized educational tests may be applied to research involving children. This category may also apply to research with children when the investigator observes public behavior but does not participate in that behavior or activity.

This section is not applicable to survey or interview research involving children.

Category 3: Identifiable Subjects in Special Circumstances

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) of this section, if

  • the human subjects are elected or appointed public officials or candidates for public office; or
  • Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter

Examples of exempt research:

  • Interviewing public officials about issues, news, or their duties.

Category 4: Existing Data: Records Review, Pathological Specimens

Research involving the collection or study of existing retrospective data, documents, records, pathological or diagnostic specimens, if

  • these sources are publicly available or
  • if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subject

Examples of exempt research:

  • Analyzing de-identified tissue samples or data set
  • Analyzing de-identified national test scores
  • Analyzing census data about aging or housing

Retrospective means "on the shelf" at the time research is inititated. If additional data or materials are collected after research is initiated, the research on that data is prospective and does not qualify for exemption.

If any data contains direct or indirect means of identifying subjects, the use of that data is not exempt. For example, a data set on cancer occurrence in a geographic area does not contain names, social security numbers, hospital records, or insurance information. It does however, list the city and street addresses of subjects' homes, which constitutes an indirect identifier, so the research on that data is not exempt.

Category 5: Research on government public benefit or service programs conducted by or approved by the heads of the department or agency being studied.

It is unlikely that your research qualifies for Category 5. If you believe it does, consult with the ORC director before choosing this category.

Category 6: Food Quality and Consumer Acceptance Studies

Taste and food quality evaluation and consumer acceptance studies, if

  • wholesome foods without additives are consumed or
  • 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.

Note: Consent should always be obtained for research in this category. This category may be applied to research involving children, as long as parental consent is obtained.

Examples of exempt research:

  • Taste testing of safe food products
  • Comparing taste, smell, texture of safe food ingredients