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TYPES OF IRB REVIEW: EXPEDITED
The federal government requires that copies of ALL research proposals involving human subjects be on file with the Institutional Review Board. According to the U.S. Office of Human Research Protections, an expedited review of the research is available for activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories. The IRB will consider this list in determining the type of review applicable to the project.
DISCLAIMERS: Categories apply regardless of the age of subjects, except as noted. This form should not be used where identification of subjects and/or their responses may place them at risk of criminal or civil liability or be damaging to their financial standing, employability, insurability, reputation, or be stigmatizing unless the protocol is designed to protect confidentiality. Standard requirements for informed consent apply regardless of the type of review. Categories (1) through (7) pertain to both initial and continuing research.
| 1. |
Clinical studies of drugs and medical devices
only when condition (a) or (b) is met. |
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a. |
Research on drugs for which an investigational new drug application
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.); and |
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b. |
Research on medical devices for which (i.) an investigational
device exemption application is not required; or (ii.) the medical
device is cleared for marketing and used in accordance with
its labeling |
| 2. |
Research on drugs for which an investigational
new drug application (21 CFR Part 312) is not required; see
reverse side for details. 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. |
| 3. |
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
for marketing and is being used in accordance with its cleared/approved
labeling. |
| 4. |
Collection of blood samples by finger stick, heel
stick, ear stick, or venipuncture from adults and children under
restrictions. |
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a. |
From healthy, non-pregnant 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 |
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b. |
From other adults and children, considering the age, weight,
and health of the subjects, the collection procedure, the amount
of the 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. |
| 5. |
Prospective collection of biological specimens
for research purposes by non-invasive means, such as hair and
nail clippings, sweat, and saliva. Examples: |
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a. |
hair and nail clippings in a non-disfiguring manner; deciduous
teeth at time of exfoliation or if routine patient care indicates
a need for extraction; permanent teeth if routine patient
care indicates a need for extraction; excreta and external
secretion (including sweat); 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; placenta removed at delivery;amniotic fluid obtained
at the time of rupture of the membrane prior to or during
labor;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; |
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b. |
mucosal and skin cells collected by buccal scraping or swab,
skin swab, or mouth washings; sputum collected after saline
mist nebulization. |
| 6. |
Collection of data through non-invasive procedures
(not involving general anesthesia or sedation) routinely employed
in clinical practice, excluding procedures involving x-rays
or microwaves. When medical devices are employed, they must
be cleared/approved for marketing. |
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(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.) |
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Examples: |
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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;weighing or testing sensory acuity;magnetic resonance
imaging;electrocardiography, electroencephalography, thermography,
detection of naturally infrared imaging, doppler blood flow,
and echocardiography; |
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b. |
moderate exercise, muscular strength testing, body composition
assessment, and flexibility testing where appropriate given
the age, weight, and health of the individual. |
| 7. |
Research
involving materials (data, documents, records, or specimens)
that have been collected, or will be collected solely for
non-research 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. |
| 8. |
Collection
of data from voice, video, digital, or image recordings made
for research purposes. |
| 9. |
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. |
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NOTE:
Some research in this category may be exempt from 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. |
| 10. |
Continuing
review of research previously approved by the convened IRB
as follows: |
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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 |
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b. |
where no subjects have been enrolled and no additional
risks have been identified; or |
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c. |
where the data analysis poses ongoing risk to participants
(e.g., privacy or confidentiality issues). |
| 11. |
Continuing
review of research, not conducted under an investigational
new drug application or investigational device exemption where
categories (2) through (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. |
See clarification of Expedited Category 10.
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