Review Categories

Categories of research that do not require full IRB review

Research activities in which the only involvement of human subjects is in one or more of the following categories are exempt from regulations requiring review. The exempt categories apply to both children and adults, except as noted under item #2 below.

  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:
    1. research on regular and special education instructional strategies; or
    2. research on the effectiveness of or the comparison among instructional
      techniques, curricula, or classroom management methods.
  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. information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot be readily ascertained, directly or through identifiers linked to the subjects; and
    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, or reputation.Note: For children, educational tests are exempt from review. Observation of public behavior is exempt if the investigator does not materially participate in the activity being observed. Surveys and interviews are not exempt.
    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 IRB conducts a review to make an exempt determination.
    4. NOTE: For children, educational tests are exempt from review. Observation of public behavior is exempt if the investigator does not materially participate in the activity being observed.

  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 the 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;
    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 IRB conducts a review to make an exempt determination;
    4. 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 that 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; or
    5. 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.
  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; or
    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.
  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:
    1. public benefit or service programs;
    2. procedures for obtaining benefits or services under those programs;
    3. possible changes in or alternatives to those program or procedures;or
    4. possible changes in methods or levels of payments for benefits or
      services under those programs.
  6. Taste and food quality evaluation and consumer acceptance studies, if:
    1. wholesome foods without additives are consumed; or
    2. a food is consumed that contains a food ingredient or agricultural chemical or environmental contaminant at or below the level and for a use found to be safe by the Food and Drug Administration or ap-proved by the Environmental Protection Agency or the Food Service and Inspection Service of the U. S. Dept. of Agriculture.

Research in the following categories, if it presents no more than minimal risk to human subjects, may be reviewed using an expedited procedure. The categories apply to both children and adults. Note: The descriptions below are abbreviated from the original. The IRB will be guided by the official wording as printed in the Federal Register.

  1. Clinical studies of approved drugs and medical devices used in accordance with standard approved medical practice.
  2. Collection of blood by finger stick, heel stick, ear stick, or venipuncture, in amounts and under schedules specified by federal regulation 63 FR60364-60367. Note: The regulation places differing restrictions on studies of adults and children.
  3. Collection of biological specimens by noninvasive means. Examples are:
    1. hair and nail clippings,
    2. teeth routinely shed or extracted,
    3. excreta and external secretions,
    4. uncannulated saliva,
    5. placenta removed at delivery,
    6. amniotic fluid collected at the time of rupture of the membrane,
    7. dental plaque and calculus collected in accordance with accepted prophylactic techniques,
    8. mucosal or skin cells collected by scraping, skin swab, or mouth washing, and
    9. sputum collected after saline mist nebulization.
  4. Collection of data through noninvasive procedures routinely used in clinical practice, excluding x rays and microwaves. Examples are:
    1. physical sensors that involve no significant input of energy into the subject or invasion of the subject’s privacy;
    2. weighing or testing sensual acuity;
    3. magnetic resonance imaging;
    4. electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography;
    5. moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the subject’s age, weight, and health.
  5. Research involving existing data, documents, records, or specimens collected solely for nonresearch purposes. Note, some research of this kind may fall into one of the exempt categories.
  6. Voice, video, digital, or image recordings made for research purposes.
  7. Research on individual or group characteristics or behavior (including but not limited to perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
    Note: Some research of this kind may fall into one of the exempt categories.
  8. Continuing review of research previously approved at an IRB meeting, where no new human subjects have been enrolled, data collection is relatively inactive, and no new risks have been identified.
  9. Continuing review of research previously determined at an IRB meeting to involve only minimal risk, where no new risks have been identified.