Criteria
for Research Considered Criteria
for Research ConsideredResearch activities involving no more than minimal risk and in which the only involvement of human participants will 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.
*Note: All research activities that do not fit the following categories must be submitted for full review.
4. Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate participants' behavior and the research will not involve stress to subjects.
5. Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.
6. Collection of hair and nail clippings, in a nondisfiguring manner; deciduous teeth; and permanent teeth if patient care indicates a need for extraction.
7. Collection of excreta and external secretion including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor.
8. Recording of data from participants 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 participant or an invasion of the participant's privacy. It also includes such procedures as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (e.g., x-rays, microwaves).
9. Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an 8-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.
10.
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.
Last updated: August, 2006
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This site was authored by Dr. Catherine Pittman and Zhou Zhu as the product of a faculty / student special project.