Category 1: Clinical studies of drugs and medical devices only when (a) the research is on drugs for which an investigational new drug application (21 CFR 312) is not required or (b) the research is on medical devices for which (i) an investigational device exemption application (21 CFR 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.
Category 2: Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from (a) healthy, non‑pregnant adults who weigh at least 110 pounds for whom (i) the amounts drawn do not exceed 550 ml in an 8 week period and (ii) collection does not occur more frequently than 2 times per week or (b) other adults and children, for whom, considering the age, weight, and health of the participants, and the collection procedures, (i) the amount of blood to be collected does not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and (ii) collection does not occur more frequently than 2 times per week. (Note: Children are defined as "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.")
Category 3: Prospective collection of biological specimens for research purposes by noninvasive means, including, but not limited to: (a) hair and nail clippings, in a non‑disfiguring 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 gum base 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; and (j) sputum collected after saline mist nebulization.
Category 4: Collection of data through non‑invasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x‑rays or microwaves. Such procedures include, but are not limited to: (a) physical sensors that are applied either to the surface of the body at a distance and do not involve input of significant amounts of energy into the participant or an invasion of the participant'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; and (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual. (Note: Where medical devices are employed, they must be cleared/approved for marketing.)
Category 5: Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected, solely for non‑research purposes (such as medical treatment or diagnosis).
Category 6: Collection of data from voice, video, digital, or image recordings made for research purposes.
Category 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. |
