Exempt 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.

back to top

Examples of Research Exempt under Category 1

  • A study evaluating the effectiveness of a commonly accepted science curriculum. For the study, investigators will observe classroom instruction and collect quizzes and class evaluations that are part of the curriculum and classroom practices.
  • A study comparing two curricula that are currently being implemented in a school. investigators will observe classrooms as well as interview instructors about their experiences implementing the instructional materials (but not about specific students).
  • A study comparing driver's education curricula offered by area driving schools. The investigator will observe classes and compare driving test scores at the end of the courses.

For more information, consult our Category 1 FAQ handout.

back to top

Category 1 FAQs

What is a commonly accepted educational setting?

In the context of Category 1 exemptions, commonly accepted educational settings include but are not limited to K-12 schools, college classrooms, after-school programs, preschools, vocational schools, alternative education programs, and other sites where educational activities regularly occur.

What is a normal educational practice?

In the context of Category 1 Exemptions, normal educational practices are established teaching methods, curriculum content and commonly accepted classroom management techniques that are planned and implemented by the classroom teacher. 

Normal educational practices are activities that would be occurring regardless of whether or not the research is conducted. Therefore, a study that evaluates a new instructional strategy or curriculum, or that randomly assigns students to different instructional strategies/curricula for the purpose of comparison, would probably not be exempt because these are not considered normal educational practices.

What if my educational research involves surveys, interviews, or focus groups?

In the context of Category 1 Exemptions, studies involving surveys, interviews or focus groups may or may not meet the criteria for a Category 1 exemption.  If the surveys, interviews or focus groups are being planned and implemented by the classroom teacher and would take place whether or not the research occurs, then the research could include them and still meet the criteria for the Category 1 exemption. 

If the surveys, interviews or focus groups are being planned and implemented by the investigator and would not be taking place if the research was not occurring, then the research may not meet the criteria for a Category 1 exemption. This would depend on the nature of the surveys, interviews or focus groups. As long as the questions asked/information solicited are specific to an established or commonly accepted educational settings and normal educational practices, study activities under Category 1 may involve surveys, focus groups, interviews. However, if the questions asked/information solicited include any any demographic questions to be asked of subjects, a discussion of how they are being utilized to evaluate the effectiveness of, or the comparison among, instructional techniques, curricula, or classroom management methods for the different groups for whom demographic data is being collected would need to be provided and the study may or may not meet the criteria for a Category 1 exemption. 

What if my educational research involves parent focus groups?

A parent focus group may or may not meet the criteria for a Category 1 exemption.  If the focus group is being planned and implemented by the classroom teacher and would take place whether or not the research occurs, then the research could include the parent focus groups and still meet the criteria for the Category 1 exemption. 

If the parent focus group is being led by the investigator and would not be taking place if the research was not occurring, then the research may not meet the criteria for a Category 1 exemption.  It may be the case, however, that the parent focus group portion of the research could qualify for a Category 2 exemption. Category 2 exemptions do not apply to minors, but might apply to a parent focus group, where the information being collected would likely be very low-risk.

What if my educational research involves audio/video-recording?

The exemption criteria for Category 1 says nothing specific about audio/video-recording. Audio/video-recording may be permissible in a Category 1 exemption, so long as the research will be taking place in a commonly accepted educational setting and will be examining normal educational practices. However, investigators should review and adhere to the school's or other educational institution's policies on audio/video-recording students and classroom instruction.

back to top


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 readily be ascertained, directly or through identifiers linked to the subjects;

  2. 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

  3. 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 the UC Santa Cruz Institutional Review Board (UCSC IRB) Chair and/or IRB Chair’s designee(s) conducts a limited IRB review to make the determination required by §46.111(a)(7).

Exempt Category 2 does not apply to research with children (45 CFR Part 46 Subpart D) except for research involving educational tests (cognitive, diagnostic, aptitude, achievement) or observations of public behavior when the investigator(s) do not participate in the activities being observed.

Examples of Research Exempt under Category 2

  • A study involving an anonymous survey regarding workplace satisfaction at area businesses.
  • An observational study of pedestrians crossing a street; the researcher takes notes of what occurs, recording sex, race, and type of clothing of pedestrians, but does not interact with subjects.
  • A study involving interviews with college seniors(age 18 and older) about their plans after graduation. The answers to questions asked would present no risks to subjects if divulged outside the research.
  • A study involving focus groups with expectant mothers regarding their perceptions of parenting education.

Category 3

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:

  1. 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;
  2. 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
  3. 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 the UC Santa Cruz Institutional Review Board (UCSC IRB) Chair and/or IRB Chair’s designee(s) conducts a limited IRB review to make the determination required by §46.111(a)(7).
(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.

back to top

Examples of Research Exempt under Category 3

  • A study that involves asking the subjects to play an online game that takes 30 minutes to complete.
  • A study that involves asking subjects to solve puzzles under various noise conditions. Study procedures take about 2 hours. 
  • Having subjects decide how to allocate a nominal amount of received cash between themselves and someone else

back to top


UCSC 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.

NOTE: There are certain exclusions that apply to category 3x as described below:

  • Research funded by any Common Rule department or agency. To find funding agencies to which the regulations apply see Common Rule Departments and Agencies and HHS Agencies & Offices, or check with your sponsor to see if they follow the Common Rule.
  • Prisoners as subjects.
  • Children/minors as subjects.
  • Federal personnel or the Department of Veterans Affairs.
  • Procedures, devices, or drugs subject to FDA oversight.
  • Biomedical procedures.
  • Clinical interventions.
  • Sponsor or other contractual restrictions.
  • An NIH-issued Certificate of Confidentiality to protect identifiable research data.
  • Deception or incomplete disclosure to subjects.
  • Identifiable, private existing data.
  • 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.

back to top

Examples of Research Exempt under Category 3x

  • A research study in which subjects will perform any of the following:
    • 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”).
    • playing a game.
  • A research study that involves the passive monitoring of space (environment) with sensors.
  • A research study that involves obtaining subjects’ height and/or weight measurements.
back to top

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:

  1. The identifiable private information or identifiable biospecimens are publicly available;

  2. 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;

  3. this criteria is not utilized at UCSC; or

  4. The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research 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.

NOTE: 

  • To qualify for this exemption the study data must be recorded in such a way that the information can no longer be connected to the identity of the subjects although investigators may initially have access to private identifiable data. This means that the abstracted data set cannot include direct identifiers (names, social security numbers, addresses, phone numbers, etc.) or indirect identifiers (codes or pseudonyms that are linked to the subject's identity). Investigators should ensure they have the ability to abstract/record the data in such a manner before proceeding with a submission.
  • The terms and conditions associated with receiving existing data or biospecimens and the original intended use of the data/biospecimens as outlined in the consent form subjects originally signed may affect whether a study qualifies for exemption. Investigators should contact the provider of the data or biospecimens to obtain this information before proceeding with a submission.

back to top

Examples of Research Exempt under Category 4

  • A research study in which a student will be given access to data from a health survey research project. The data consists of coded survey responses, and the Principal Investigator of the health survey research project in which the data was collected will retain a key that would link the data to identifiers. The student will extract the information she needs for her project without including any identifying information and without retaining the code. The use of the data does constitute research with human subjects because the initial data set is identifiable (albeit through a coding system); however, it would qualify for exempt status.
  • A research study of treatment outcomes for a certain drug that involves the review of patient charts at a non-UCSC medical facility. The researcher records patient age, sex, diagnosis, and treatment outcome in such a way that the information cannot be linked back to the patient.

back to top


Category 5

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 the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and 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. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.

To find funding agencies to which the regulations apply see Common Rule Departments and Agencies and HHS Agencies & Offices.

NOTE:

  • Exemption Category 5 only applies to research on public benefit programs (such as Social Security) conducted or supported by the federal government and therefore is rarely, if ever, applied to research at UCSC. Research and demonstration projects in general (e.g., state or city funded public service programs) do not fit under this exempt category. 
  • Each Federal department or agency conducting or supporting the research and demonstration projects must establish (on a publicly accessible Federal website or in such other manner as the department or agency head may determine) a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.

back to top

Examples of Research Exempt under Category 5

  • Research studies that include, but are not limited to, internal studies by Federal employees, and studies under contracts of consulting arrangements, cooperative agreements, or grants.

back to top


Category 6

(See also FDA’s Exempt Category)

Taste and food quality evaluation and consumer acceptance studies:

  1. If wholesome foods without additives are consumed, or

  2. 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: 

  • Taste and food quality evaluation studies conducted under this exemption may not involve the consumption of any type or volume of food that would present any risk to the subjects and should fall into what would be considered reasonable eating behaviors by the subject. 
  • The food must be “wholesome” (no additives), or if it involves plants or animals raised for food products, the level of chemical additives or environmental contaminants must be at or below the levels approved by the FDA, EPA, or USDA. Studies involving the consumption of alcohol, vitamins, and other supplements do not qualify for exempt status. 

back to top

Examples of Research Exempt under Category 6

  • A research study involving a taste-test on different varieties of a fruit to determine consumer preference, when the fruits do not have any additives and subjects are asked to indicate which fruit they prefer. 
  • A research study that involves taste-testing of various beef products from cattle that have been given feed 

back to top