Policy on Protection of Human Subjects
B) Level II Research and Review (minimal risk)
Nature of the Study: Research activities involving "no more than minimal risk" and in which the only involvement of human subjects will be in one or more of the following categories:
1. Collection of hair and nail clippings, in a non-disfiguring manner; deciduous teeth; and permanent teeth if patient care indicates a need for extraction.
2. 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.
3. Recording of data from subjects 18 years of age or older using non-invasive 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, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (for example, X-rays, microwaves).
4. 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 not pregnant.
5. 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.
6. Voice recordings made for research purposes such as investigations of speech defects.
7. Moderate exercise by healthy volunteers.
8. The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
9. Research on individual or group behavior or characteristics of individuals such as perception, cognition, game theory, or test development, where the investigator does not manipulate subjects' behavior and the research will not involve stress to subjects.
10. Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.
Nature of the Review:Two members of the committee (usually including the chair) review the documentation presented with the proposal. Recommendations for improvements are sent in writing (electronic text is acceptable as long as a paper copy is kept for the records of the institution). Questions of clarity require a written response from the researcher (electronic text is acceptable as long as a paper copy is kept for the records of the institution).