Expedited Review

Expedited Review Categories (45 CFR 46.101[b])

1. The University IRB may use the expedited review procedure to approve certain protocols during the period for which approval is authorized.

2. The only other research for which the University IRB may use an expedited review procedure, in compliance with 45 CFR Part 46 is that which involves no more than minimal risk to the subjects 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 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, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (i.e., X-rays, microwaves).

   4. 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.

   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 studies of perception, cognition, game theory, or test development, where the research 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.

   11. Any other category specifically added to this list by DHHS and published in the Federal Register.

Expedited review shall be conducted by the IRB chairperson or by one or more of the experienced IRB members designated by the chairperson to conduct the review. The IRB member conducting the expedited review may exercise all of the authorities of the IRB except that the reviewer may not disapprove the research. The reviewer shall refer any research protocol which the reviewer would have disapproved to the Full IRB for review. The reviewer may also refer other research protocols to the Full IRB whenever the reviewer believes that Full IRB review is warranted.

When the expedited review procedures is used, the IRB chairperson or member(s) conducting the review shall inform IRB members of research protocols which have been approved under the procedure.

At a convened IRB meeting, any member may request that an activity which has been approved under the expedited procedure be reviewed by the IRB in accordance with non-expedited procedures. A vote of the members shall be taken concerning the request and the majority shall decide the issue.

Please feel free to contact the staff if you have any questions
about the IRB application process.