Effective Date: March 28, 2003
Expiration Date: September 07, 2013
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Research activities involving no more than minimal risk and in which the involvement of human subjects shall be in one or more of the following categories (carried out through standard methods), may be reviewed by the IRB through the expedited review procedure authorized in Federal Policy Regulations cited in 45 CFR 46.110 and 14 CFR 1230.110.
1. Collection of hair and nail clippings, in a nondisfiguring manner, deciduous teeth, and permanent teeth if normal preventive patient care indicates a need for extraction.
2. Collection of excreta and external secretions, including sweat, noncannulated saliva, and placentas removed at delivery, and amniotic fluid at the time of membrane rupture prior to or during labor.
3. 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 privacy. It also includes such procedures as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, and detection of naturally occurring radioactivity, diagnostic sonography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (e.g., X-rays, microwaves, ultraviolet light, and infrared lights).
4. Collection of both supra and subgingival 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.
5. Voice recordings made for research purposes such as investigations of speech defects or stress.
6. Moderate exercise performed by healthy subjects.
7. The study of existing data, documents, records, pathological specimens, or diagnostic specimens. In the latter two instances, a new informed consent statement must be obtained.
8. Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, in which the PI does not manipulate the subject's behavior and the research does not involve stress to the subjects.
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