Determination of Human Subjects Risk and IRB Review Category

There are three categories of human research review: Exempt, Expedited and Full Board. These categories of review are determined by whether or not the risk to human subjects is less than, equal to, or greater than minimal risk.

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Exempt Review*

Exempt research projects present less than minimal risk or risks so benign to the human subjects who participate in them, that they are not subject to federal regulations. To qualify for exemption, the research must fit into one or more of the following 8 categories:

  1. Exemption For Education: Research conducted in established or commonly accepted educational settings, involving normal educational practices that are not likely to adversely impact: a) students’ opportunity to learn required educational content, or b) the assessment of educators who provide instruction. Could include (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 is exempted.
  2. Exemption For Research Involving Educational Tests, Surveys, Interviews, and Observations of Public Behavior: when (a) information recorded cannot be readily linked back to subjects, or (b) any information disclosure would not place subjects at risk of harm, or (c) identifiable information is recorded with limited IRB review for privacy and confidentiality protection.
  3. Exemption For Research Involving Benign Behavioral Interventions with Adults who Prospectively Agree when Information Collection is Limited to Verbal or Written Responses (including data entry) or Audiovisual Recording, and: (a) information recorded cannot be readily linked back to subjects, or (b) any information disclosure would not place subjects at risk of harm, or (c) identifiable information recorded with limited IRB review for privacy and confidentiality protection.
  4. Exemption for Secondary Use of Identifiable Private Information or Identifiable Biospecimens for which Consent is not Required if: (a) identifiable private information or identifiable biospecimens are publicly available, or (b) information, which may include information about biospecimens, 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, the investigator does not contact the subjects or re-identify subjects, or (c) investigator’s use is regulated under HIPAA as “health care operations,” “research,” or “public health,” or (d) research is conducted by, or on behalf of, a Federal agency using data collected or generated by the government for non-research purposes, and the information is protected by federal privacy standards.
  5. Exemption for Research and Demonstration Projects Conducted by or Subject to Approval of Federal Departments or Agencies: Research and demonstration projects which are conducted and/or supported by or subject to the approval of department or agency heads are exempted if they 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.
  6. Exemption for Taste and Food Quality Evaluation and Consumer Acceptance Studies: Taste and food quality evaluation and consumer acceptance studies are exempted if, (i) wholesome foods without additives are consumed; or (ii) 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 FDA or approved by EPA or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
  7. Exemption for Storage or Maintenance of Identifiable Private Information or Identifiable Biospecimens for Secondary Research.
  8. Exemption for Secondary Research Using Identifiable Private Information or Identifiable Biospecimens.

*Limited Review, a sub-category of Exempt Review is sometimes used to confirm exempt status.

Expedited Review

If your project does not qualify for an exemption and the risk of harm anticipated in the research is not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests, your project is minimal risk. Expedited research projects present minimal risk according to the following 7 minimal risk categories:

  1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
    1. Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
    2. Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
  2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture:
    1. from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
    2. from other adults and children2, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
  3. Prospective collection of biological specimens for research purposes by noninvasive means.
    • Examples:
      1. Hair and nail clippings in a nondisfiguring manner
      2. Deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction
      3. Permanent teeth if routine patient care indicates a need for extraction
      4. Excreta and external secretions (including sweat)
      5. Uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue
      6. Placenta removed at delivery
      7. Amniotic fluid obtained at the time of rupture of the membrane prior to or during labor
      8. Supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques
      9. Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings
      10. Sputum collected after saline mist nebulization.
  4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)
    • Examples:
      1. Physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject=s privacy
      2. Weighing or testing sensory 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 age, weight, and health of the individual.
  5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects.
  6. Collection of data from voice, video, digital, or image recordings made for research purposes.
  7. Research on individual or group characteristics or behavior (including, but not limited to, research on 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 in this category may be exempt from the HHS regulations for the protection of human subjects.)

Full Board Review

If your project involves more than "minimal risk" to subjects (e.g., risk of harm anticipated in the research is greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests) or utilizes deception, your project is categorized as risk or deception and requires full board review.

If you have any questions, please contact:

Dr. Janessa Doucette
Director
janessa.doucette@cuw.edu
262-243-2721