Expedited Projects
An expedited review procedure consists of a review of research
involving human subjects by the IRB chairperson or by one or more
experienced reviewers designated by the chairperson from among members
of the IRB in accordance with the requirements set forth in 45
CFR 46.110.
The activities listed should not be deemed to be of minimal risk
simply because they are included on this list. Inclusion on this
list merely means that the activity is eligible for review through
the expedited review procedure when the specific circumstances of
the proposed research involve no more than minimal risk to human
subjects.
The CSUF IRB has agreed that some of the below-listed expedited
projects be reviewed by full committee because of the possible increase
of risk to subjects and beneficial decrease in renewal time for
approval. You will be notified if your expedited protocol requires
full committee review. Please also note that any expedited project
which involves children will be reviewed by CSUF IRB at full committee.
Expedited review procedures include, but are not limited to:
(1) Clinical studies of drugs and medical devices only
when condition (a) or (b) is met.
(a) Research on drugs for which an investigational
new drug application (21 CFR Part 312) is not required. (Note: Research
on marketed drugs that significantly increases the risks or decreases
the acceptability of the risks associated with the use of the product
is not eligible for expedited review.)
(b) Research on medical devices for which
(i) an investigational device exemption application (21 CFR Part
812) is not required; or (ii) the medical device is cleared/approved
for marketing and the medical device is being used in accordance
with its cleared/approved labeling.
(2) Collection of blood samples by finger stick, heel stick,
ear stick, or venipuncture as follows:
(a) from healthy, nonpregnant adults
who weigh at least 110 pounds. For these subjects, the amounts drawn
may not exceed 550 ml in an 8 week period and collection may not
occur more frequently than 2 times per week; or
(b) from other adults and children, considering the age, weight, and health
of the subjects, the collection procedure, the amount of blood to
be collected, and the frequency with which it will be collected.
For these subjects, the amount drawn may not exceed the lesser of
50 ml or 3 ml per kg in an 8 week period and collection may not
occur more frequently than 2 times per week.
(3) Prospective collection of biological specimens for research
purposes by noninvasive means.
Examples: (a) hair and nail clippings
in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation
or if routine patient care indicates a need for extraction; (c) permanent
teeth if routine patient care indicates a need for extraction; (d)
excreta and external secretions (including sweat); (e) uncannulated
saliva collected either in an unstimulated fashion or stimulated
by chewing gumbase or wax or by applying a dilute citric solution
to the tongue; (f) placenta removed at delivery; (g) amniotic
fluid obtained at the time of rupture of the membrane prior to or
during labor; (h) supra- and subgingival dental plaque and calculus,
provided the collection procedure is not more invasive than routine
prophylactic scaling of the teeth and the process is accomplished
in accordance with accepted prophylactic techniques; (i) mucosal
and skin cells collected by buccal scraping or swab, skin swab,
or mouth washings; (j) sputum collected after saline mist nebulization.
(4) Collection of data through noninvasive procedures (not involving
general anesthesia or sedation) routinely employed in clinical practice,
excluding procedures involving x-rays or microwaves. Where medical
devices are employed, they must be cleared/approved for marketing.
(Studies intended to evaluate the safety and effectiveness of the
medical device are not generally eligible for expedited review,
including studies of cleared medical devices for new indications.)
Examples: (a) physical sensors that are
applied either to the surface of the body or at a distance and do
not involve input of significant amounts of energy into the subject
or an invasion of the subject=s privacy; (b) weighing or testing
sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography,
electroencephalography, thermography, detection of naturally occurring
radioactivity, electroretinography, ultrasound, diagnostic infrared
imaging, doppler blood flow, and echocardiography; (e) moderate
exercise, muscular strength testing, body composition assessment,
and flexibility testing where appropriate given the age, weight,
and health of the individual.
(5) Research involving materials (data, documents, records,
or specimens) that have been collected, or will be collected solely
for nonresearch purposes (such as medical treatment or diagnosis).
(NOTE: Some research in this category may be exempt from the HHS
regulations for the protection of human subjects. 45
CFR 46.101(b)(4). This listing refers only to research that
is not exempt.)
(6) Collection of data from voice, video, digital, or image
recordings made for research purposes.
(7) Research on individual or group characteristics or behavior
(including, but not limited to, research on perception, cognition,
motivation, identity, language, communication, cultural beliefs
or practices, and social behavior) or research employing survey,
interview, oral history, focus group, program evaluation, human
factors evaluation, or quality assurance methodologies. (NOTE: Some
research in this category may be exempt from the HHS regulations
for the protection of human subjects. 45
CFR 46.101(b)(2) and (b)(3). This listing refers only to research
that is not exempt.)
(8) Continuing review of research previously approved by the
convened IRB as follows:
(a) where (i) the research is permanently
closed to the enrollment of new subjects; (ii) all subjects have
completed all research-related interventions; and (iii) the research
remains active only for long-term follow-up of subjects; or
(b) where no subjects have been enrolled
and no additional risks have been identified; or
(c) where the remaining research activities
are limited to data analysis.
(9) Continuing review of research, not conducted under an investigational
new drug application or investigational device exemption where categories
two (2) through eight (8) do not apply but the IRB has determined
and documented at a convened meeting that the research involves
no greater than minimal risk and no additional risks have been identified.
1 Children
are defined in the HHS regulations as "persons who have not
attained the legal age for consent to treatments or procedures involved
in the research, under the applicable law of the jurisdiction in
which the research will be conducted." 45
CFR 46.402(a).
Source:
63 FR 60364-60367, November 9, 1998
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