Expedited review protocols are usually the studies that pose no more than minimal risks to the participants and do not utilize minors or other vulnerable participants. Examples include studies using questionnaires, surveys, and interviews that are not anonymous but do not involve sensitive topics or minors. A protocol cannot be disapproved via the expedited review process. If there are significant questions or concerns, you will be notified to submit the protocol for full review.
Research activities which may be reviewed through the expedited research process are projects 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):
a. Collection of hair and nail clippings in a non-disfiguring manner, deciduous teeth and permanent teeth if patient care indicates a need for extraction.
b. 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.
c. Recording of data for subjects 18 or older using noninvasive procedures routinely employed in clinical practice. This involves the use of physical sensors that are applied to either 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 or microwaves).
d. 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 or older who are in good health and not pregnant.
e. 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 accompanied in accordance with accepted prophylactic techniques.
f. Voice recordings made for research purposes, such as investigations of speech defects.
g. Moderate exercise by healthy volunteers.
h. The study of existing data, documents, records, pathological specimens or diagnostic specimens.
i. Research on individual or group behavior or characteristics of individuals such as studies of perception, cognition, game theory or test development, in which the investigator does not manipulate subjects' behavior and the research will not involve stress to subjects.
j. Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption are not required.