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Exempt and expedited reviews require that a research project is of no more than minimal risk to the subjects participating in the project and that the project falls under a category identified by OHRP as acceptable for exempt or expedited review. When submitting your IRB application as either exempt or expedited, you must identify which category your project falls under and give a brief explanation of why this category fits your project. This research must also be of no more than minimal risk to subjects.
Section 46.104 of 45 CFR 46 identifies eight categories under which a research project may be submitted for Exempt IRB review, and the 1998 OHRP Expedited Review Categories notice identifies nine categories under which a research project may be submitted for Expedited IRB review. These categories are listed below.
If your project does not fit under any of the categories for Exempt or Expedited Review, or if your project is of more than minimal risk to participants, you must submit your project for full review. If you are unsure of which category your project fits, please contact the Northwest IRB through its email address (IRBNWMS@nwmissouri.edu).
More information related to categories of IRB review can be found in the Northwest IRB Submission Guide and within the current OHRP rules and regulations, available at this link.
Within category descriptions, most information is taken directly from the OHRP 45 CFR 46 regulations. In some cases, additional information is provided beyond that of the official regulations; this information is presented in italics.
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.
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).
There are three subcategories within Category 2. If you believe your project is Category 2 Exempt, you must specify which subcategory it fits within:
Subcategory 2-I: 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.
Subcategory 2-II: 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.”
Subcategory 2-III: 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 an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7).
Important: Projects involving children as subjects cannot be submitted as exempt under subcategory 2-III, and they may only be submitted as exempt under subcategories 2-I or 2-II if the investigator does not participate in data collection or observation.
If your project does not meet the criteria above, but otherwise would fit under this category, see Expedited Categories 6 and 7 below.
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.
At least one of the following criteria must also be met:
If your project does not meet the criteria above, but otherwise would fit under this category, see Expedited Category 7 below.
Note that category 3 does not apply for projects where subjects will be deceived about the true nature of the study, unless subjects are aware that they will be deceived beforehand. Category 3 also does not apply to research with children.
Examples of benign behavioral interventions provided by OHRP 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.”
Secondary research for which consent is not required, including secondary research which involves identifiable private information.
At least one of the following criteria must also be met:
If your project does not meet any of the criteria above, but otherwise would fit under this category, see Expedited Category 5 below.
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… and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs… Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants.
Taste and food quality evaluation and consumer acceptance studies, as long as wholesome foods without additives are consumed or 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 o the Food Safety and Inspection Service of the US Department of Agriculture.
Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §46.111(a)(8).
Secondary research for which broad consent is required, as long as all of the following criteria are met:
Note that broad consent is not the same thing as informed consent. Broad consent is a special form of consent that applies to storage and usage of data for possible secondary research projects. Broad consent is not covered in this document or in the Northwest IRB Submission Guide; if you believe your study falls under this category or that you wish to obtain broad consent, see section 46.116 of the OHRP guidelines for more information.
In 1998, OHRP outlined a list of nine approved categories of research that may be considered with an expedited IRB review. Most information within category descriptions is taken from this policy document which can be read in full at this link. In some cases, additional information is provided beyond that of the official regulations; this information is presented in italics.
Clinical studies of drugs and medical devices that are no more than minimal risk and fall into one of two approved categories:
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture:
Prospective collection of biological specimens for research purposes by noninvasive means.
The policy document provides a specific set of examples for this category; while this set is not exhaustive, it should be informative for what OHRP deems “noninvasive” and not more than minimal risk.
Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) 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; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) 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; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
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).
As with category 3, the policy document provides several examples of noninvasive clinical practices that would be appropriate; again, this list is not exhaustive.
Examples: (a) 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; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, Doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
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). (Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4).
Expedited Category 5 applies for research that would have qualified under Exempt Category 4, except none of the four required criteria from Exempt Category 4 were met.
Collection of data from voice, video, digital, or image recordings made for research purposes.
This is similar to Exempt Category 2, except that the criteria allowing for exemption cannot be met. Typically, this will apply for recorded data in which subject identity could be ascertained and, if identities were ascertained, the data may place subject at risk in some manner.
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. (Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt).
As with category 6 above, this one overlaps with Exempt Category 2 (and 3). Thus, it should only be employed if subjects’ identities could be ascertained and, if ascertained, subjects’ responses could place them at risk in some way.
Continuing review of research previously approved by the convened IRB as follows, where the research is permanently closed to the enrollment of new subjects, all subjects have completed all research-related interventions, and the research remains active only for long-term follow-up of subjects; or where no subjects have been enrolled and no additional risks have been identified; or where the remaining research activities are limited to data analysis.
Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
