Department of Health and Human Services (DHHS) regulations (45 CFR 46, as amended) recognize that there are certain categories of research which involve procedures which pose no more than minimal risks to subjects and for which clear standards can be set. Accordingly, research projects which fall under one of the categories listed below will be reviewed by the Expedited Review Subcommittee, which will consist of the Institutional Review Board for the Protection of Human and animal subjects (IRB) Chair and/or one or more experienced IRB member/s selected by the Chair.
All members of the Expedited Review Subcommittee must agree that the protocol falls under one of the expedited categories. Any member may object to the application for expedited review or may have further questions that the investigator must answer. Similarly, each member has the option of referring the application to the IRB for full review.
If the application is approved by the Expedited Review Subcommittee, it will be reported to the IRB as a consent calendar item at the next convened meeting. The IRB is likely to approve the Expedited Review Subcommittee’s action but has the option of requesting more information, requiring modification of the protocol, or disapproving the project.
Listed below are eleven categories subject to expedited review. Expedited review will be given only for research protocols that fall under one of these categories. These categories, as determined by the IRB, may not apply to pregnant women, children, prisoners, mentally disabled persons, and other classes of subjects considered vulnerable.
- Minor modifications or additions to existing approved studies;
- 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 subjects’ behavior and the research will not involve stress to subjects;
- The study of existing data, documents, records, pathological specimens, or diagnostic specimens;
- Voice recordings made for research purposes such as investigations of speech defects;
- Moderate exercise by healthy volunteers;
- 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 who are in good health and not pregnant;
- Collection (in a non-disfiguring manner) of hair, nail clippings, and deciduous teeth; and permanent teeth if patient care indicates a need for extraction;
- Collection for analysis 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;
- 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 distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the subject’s privacy. (These procedures include weighing, testing sensory acuity, electrocardiogram, electroencephalogram, 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.) ;
- 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; and
- Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.