|According to federal regulations, a research study is only
eligible for expedited review if:
- The research activities involve no more than
As defined in U.S. Department of Health and Human Service, 45
Code of Federal Regulations, Part 46.102i, “minimal risk” means
that the probability and magnitude of harm or discomfort
anticipated in the research are not greater in and of themselves
than those ordinarily encountered in daily life or during the
performance of routine physical or psychological examinations or
- Research protocol does not involve any of the
- Minors (<21 years)
- Pregnant Women
- Mentally Retarded
- Mentally Disabled
- Research protocol does not include questionnaires
with sensitive areas (alcohol/drug abuse, sexual behavior, HIV
- The only involvement of human subjects is one or
more of several specified categories listed below.
- Collection of hair and nail clipping in a
non-disfiguring manner; deciduous teeth and permanent teeth
if patient care indicates a need for extraction.
- 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.
- Recording of data from subjects 21 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 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).
- 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.
- 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
- Voice recordings made for research purposes such as
investigations of speech defects.
- Moderate exercise by healthy volunteers.
- Research on individual or group behavior or
characteristics of individuals such as studies of
perception, cognition, game theory, or tests development,
where the investigator does not manipulate subjects’
behavior and the research will not involve stress to
- Research on drugs or devices for which an
investigational new drug exemption or an investigational
device exemption is not required. (Note: if an FDA approved
drug is to be used for an unapproved use, the research is
NOT eligible for expedited review.)
- The study of existing data, documents, records,
pathological specimens, or diagnostic specimens.
- In addition, the IRB may also use the expedited
review procedure to review minor changes in previously approved
research during the period for which approval is authorized. In
case where any drugs are involved in the proposed study, at
least one IRB member must be a medical physician for the