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) 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 an IRB conducts a limited IRB review to make the determination required by § 46.111(a)(7).

This category does not apply to interventions, the collection of biospecimens and research with children (except for educational tests or some public observation).

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 an IRB conducts a limited IRB review to make the determination required by § 46.111(a)(7).

Benign behavioral interventions are brief in duration, harmless, painless, not physically invasive and not likely to have a significant adverse lasting impact on the subjects and interventions that the investigator has no reason to think the subjects will find offensive or embarrassing. Examples include having participants play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of cash between themselves and others.

If the research involves deception regarding the nature or purposes of the research, the subject must be informed and prospectively agree to participate in circumstances in which they will be unaware of or misled regarding the nature or purposes of the research.

This category does not apply to research with children and physiological data collection methods that touch participants (e.g., EEG, wearable devices, blood pressure monitors).

Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

• The identifiable private information or identifiable biospecimens are publicly available.
• 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.
• The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b).
• The research is conducted by, or on behalf of, a federal department or agency using government-generated or government-collected information obtained for nonresearch 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.

This category only applies to studies working with either protected health information (PHI) or personally identifiable information (PII). If you intend to work with both PHI and PII, the research would not fit under this Exempt category.

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. 

Such projects include, but are not limited to, internal studies by federal employees and studies under contracts or consulting arrangements, cooperative agreements or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.

Taste and food quality evaluation and consumer acceptance studies if wholesome foods without additives are consumed, or 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 (FDA) or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Brown is not implementing this exemption at this time.

Read the full description of this category [45 CFR 46.104(d)(7)] in the Exemptions section of the Federal Regulations for the Protection of Human Subjects.

Brown is not implementing this exemption at this time.

Read the full description of this category [45 CFR 46.104(d)(8)] in the Exemptions section of the Federal Regulations for the Protection of Human Subjects.

Expedited Category 1 applies only to research meeting the following conditions:

• Research on drugs for which an investigational new drug application is not required

Research on medical devices for which (i) an investigational device exemption, or application 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

Expedited Category 2 involves the collection of blood samples by finger stick, heel stick, ear stick or venipuncture as follows:

• From healthy, nonpregnant adults who weigh at least 110 pounds (the amounts drawn may not exceed 550 ml in an eight-week period and collection may not occur more frequently than two times per week); or
• From other adults and children, considering their age, weight and health; the collection procedure; the amount of blood; and the collection frequency (the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an eight-week period and may not occur more than two times per week)

Expedited Category 3 involves the prospective collection of biological specimens for research purposes by noninvasive means, including the following:

• Hair and nail clippings in a nondisfiguring manner
• Deciduous teeth at the time of exfoliation or if routine patient care indicates a need for extraction
• Permanent teeth if routine patient care indicates a need for extraction
• Excreta and external secretions (including sweat)
• 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
• Placenta removed at delivery
• Amniotic fluid obtained at the time of rupture of the membrane prior to or during labor
• 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
• Mucosal and skin cells collected by buccal scraping or swabs, skin swab or mouth washings
• Sputum collected after saline mist nebulization

Expedited Category 4 involves the collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Collection methods include:

• Physical sensors applied to the surface of the body or at a distance and that do not involve input of significant amounts of energy into the subjects or an invasion of the subject’s privacy
• Weighing or testing sensory acuity
• Use of an MRI, ECG, EKG, EEG, ERG, ultrasound, diagnostic infrared imaging, thermography, detection of naturally occurring radioactivity, doppler blood flow or echocardiography
• Moderate exercise, muscular strength testing, body composition assessment and flexibility testing where appropriate given the age, weight and health of the participant

Expedited Category 5 covers research involving materials (data, documents, records or specimens) that have been collected, or will be collected, solely for nonresearch purposes.

Expedited Category 6 involves the collection of data from voice, video, digital or image recordings made for research purposes.

Expedited Category 7 involves 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.

Expedited Category 8 involves 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;
• Where no subjects have been enrolled and no additional risks have been identified; or
• Where the remaining research activities are limited to data analysis

Expedited Category 9 involves the continuing review of research, not conducted under an investigational new drug application or investigational device exemption, where categories 2-8 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.