Exempt Categories

Category 1

Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as: (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.


Category 2

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) 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.

Note: 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

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


Category 3x*

UC Category 3x: Minimal risk exempt research activities that will not induce distress beyond that of daily life may include (but are not limited to) non-physically invasive interventions or performance of tasks such as: Reading/writing/drawing tasks; Physical activities such as walking, sitting, or manipulating an object;  Computer tasks and/or Internet searches; Talking and/or listening to words, then making selections, or “think-aloud” exercises; Viewing media; Role-playing; Completing a specific physical or mental action (“imagining”); Passive monitoring of space (environment) with sensors; Playing a game; Height/weight measurements.

*Exclusions:

  1. Federally funded research, or funding from non-Public Health Service (PHS) agencies that adhere to federal regulations in their award contracts (for a current list of these agencies see http://sites.nationalacademies.org/PGA/fdp/PGA_070596);
  2. Prisoners as subjects.
  3. Children/minors as subjects.
  4. Federal personnel or the Department of Veterans Affairs.
  5. Procedures, devices, or drugs subject to FDA oversight.
  6. Biomedical procedures.
  7. Clinical interventions.
  8. Sponsor or other contractual restrictions.
  9. An NIH-issued Certificate of Confidentiality to protect identifiable research data.
  10. Deception or incomplete disclosure to subjects.
  11. Identifiable, private existing data.
  12. The information obtained is recorded in such a manner that subjects can be identified, directly or through identifiers linked to the subjects, and any disclosure of the subject’s responses outside of the research could reasonably place the subject at risk of criminal or civil liability, be damaging to the subject’s financial standing, employability, insurability, or reputation, or be stigmatizing in any other way.

Category 4

Research involving the collection or study of existing* data, documents, records, pathological specimens, 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 subjects.

*Note: "Existing" means existing before the research is proposed to the institutional review board to determine whether the research is exempt.


Category 5

Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs. 

See OHRP's guidance regarding this category


Category 6

(See also FDA’s Exempt Category) 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.


Changes to exempt projects

Investigators should consult with ORCA whenever questions arise about whether planned changes to an exempt study might make that study non-exempt.

Please email completed Exemption Request Forms to orca@ucsc.edu


Exempt Categories FAQ