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THE COMMITTEE ON HUMAN RESEARCH
UCSF GUIDANCE ON RESEARCH TOPICS AND ISSUES
EXPEDITED REVIEW
CATEGORIES
• Applicability
• Research Categories
The following pages explain what research may be reviewed using
expedited procedures. This information is quoted directly from Federal
requirements; the “Comments” have been added by CHR staff.
Categories of Research That May Be Reviewed by the Institutional
Review Board (IRB) through an Expedited Review Procedure1(published
in the Federal Register, 63 FR 60364-60367, effective November
9, 1998):
1An 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.
Applicability
(A) Research 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, may be reviewed
by the IRB through the expedited review procedure authorized by 45
CFR 46.110 and 21 CFR 56.110. 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.
(B) The categories in this list apply regardless of the age of
subjects, except as noted.
(C) The expedited review procedure may not be used where identification
of the subjects and/or their responses would reasonably place them
at risk of criminal or civil liability or be damaging to the subjects'
financial standing, employability, insurability, reputation, or
be stigmatizing, unless reasonable and appropriate protections
will
be implemented so that risks related to invasion of privacy and
breach of confidentiality are no greater than minimal.
(D) The expedited review procedure may not be used for classified
research involving human subjects.
(E) IRBs are reminded that the standard requirements for informed
consent (or its waiver, alteration, or exception) apply regardless
of the type of review--expedited or convened--utilized by the
IRB.
(F) Categories one (1) through seven
(7) pertain to both initial and continuing IRB review.
Comments: If
as part of the study subjects will be randomized
to a treatment group, then the study does not qualify for
expedited review.
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Research
Categories
| (1) A very limited number of studies of
approved drugs and devices: 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
(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. |
Comments: The drug or device must be approved and used exactly according
to its labeling. All study procedures other than use of the drug or
device must themselves be of minimal risk for the study to qualify
for expedited review. Few studies fit this category.(2)
(2) Blood sampling: Collection of blood samples by
finger
stick, heel stick, ear stick, or venipuncture as follows:
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(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 children2, 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.
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2Children 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).
(3) Noninvasive specimen collection: Prospective collection of
biological specimens for research purposes by noninvasive means
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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) Noninvasive clinical procedures: 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.) |
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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) Use of data or specimens
collected for nonresearch purposes: 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.)
Comments: (a) This category
refers to materials collected for "nonresearch purposes," but
can be used to cover research materials if the investigator's role
is simply to analyze them. That is, if an investigator is receiving
materials from colleagues who have separate approval to collect
them, and the materials are handled with code numbers and other
protections
for confidentially, he or she may apply for expedited review for
the analysis; (b) This type of research is exempt from review only
if
the data collected has no link whatsoever to identifiers (not even
a code number). Please see Part VIII for more information.
(6) Use
of recordings: Collection of data from voice, video, digital,
or image recordings made for research purposes.
(7) Low risk behavioral
research:
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.)
Comments: Only very specific
types
of behavioral research are exempt from review. Again, there
usually must be no link whatsoever to identifiers (not even
a code number).
(Please refer to Exempt
Categories of Research of these
Guidelines for more information.)
(8) Renewal of inactive research
protocols
or protocols that are essentially complete: 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
(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.
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| (9) Renewal of other minimal risk
research protocols:
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. |
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