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Eligible for Expedited/Full Review |
Human subjects research involving any of the following conditions will receive Expedited/Full Review:
Studies which, under full review, have previously been granted conditional approval if specific minor conditions are met, or where minor changes in procedures not affecting risk are proposed.
Collection of: hair and nail-clippings, in a non-disfiguring manner; deciduous teeth; and permanent teeth if patient care indicates a need for extraction.
Collection of excreta and external secretions, including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor.
Recording of data from subjects 18 years of age or older using noninvasive procedures routinely employed in clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the subject's privacy. It also includes such procedures as weighing, testing sensory acuity, electrocardiography, thermography, electroencephalography, detection of naturally-occurring radioactivity, diagnostic echography, electoretinography. It does not include exposure to electromagnetic radiation outside the visible range (e.g. x-rays, microwaves.)
Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and no more often than two times per week, from subjects 18 years of age or older and who are in good health and not pregnant.
Collection of both supra- and sub-gingival dental plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques.
Voice-recordings made for research purposes, such as investigations of speech defects.
Moderate exercise by healthy volunteers.
The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
Research on individual or group behavior of characteristics of individuals, such as studies of perception, cognition, game-theory, or test-development, where the investigator does not manipulate subjects' behavior and the research will not involve stress to the subjects.
Research on drugs or devices for which an investigational new drug-exemption or an investigational device-exemption is not required.