TYPES OF HUMAN SUBJECTS REVIEW
There
are three types of human subjects review: exempt, expedited, and standard.
The criteria for each review follows. Note that the titles of human subjects
review refer to the process involved in review, not the time required
to perform the review.
The following
categories of research are exempt from human subjects review:
- Any form of research which does
not utilize human subjects such as historical and library research
(also non-human chemistry and physics research).
- Research involving
the collection or study of existing data, documents, records, or pathological
or diagnostic specimens, if these sources are publicly available.
- Research involving
the collection or study of existing data, documents, records, or pathological
or diagnostic specimens, and the information is recorded by the investigator
in such a manner that subjects cannot be identified, directly or through
identifiers linked to the subjects, such as in content or secondary data
analyses.
- Research
involving the use of educational tests (cognitive, diagnostic, aptitude,
or achievement), survey or interview procedures, or observation of public
behavior and the subjects are elected or appointed public officials or
candidates for public office, or the subjects cannot be identified directly
or through identifiers linked to the subjects.
- Taste
and food quality evaluation and consumer acceptance studies where wholesome
foods without additives are consumed, or in which a food is consumed that
contains a food ingredient at or below the level and for a use found to
be safe, or agricultural chemical or environmental contaminant at or below
the level found to be safe by the Food and Drug Administration,
or approved by the Environmental Protection Agency, or the Food Safety
and Inspection Service of the U.S. Department of Agriculture.
The following
categories of research involving human subjects and no more than minimal
risk qualify for expedited human subjects review:
- 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.
- 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 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.
- 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.
- 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.
- 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.)
- Collection of
data from voice, video, digital, or image recordings made for research
purposes.
- 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.)
- 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.
- 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.
Any
type of research involving human subjects that does not meet the criteria
for either exempt or expedited human subjects review must be processed
through standard review procedures.
Human
Subjects Research Review Committee Home Page
Policies:
Human Subjects Forms for Submission of Proposals
The freely
available Adobe Acrobat reader is required to view or print the following
forms in PDF format.
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