1. 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 expedited review process. The categories
in this list apply regardless of the age of subjects, except
2. 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 are no greater than minimal.
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^2, 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 non-invasive means.
Examples: (a) hair and nail clippings
in a non-disfiguring 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; (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.
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).
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
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
9. Continuing review of research where
the IRB has determined and documented at a convened meeting
that the pending research/stored data involves no greater
than minimal risk and no additional risks have been identified.
1 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.
2 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).
If you have any questions about regulations
and policies, please contact Neal
Sullivan (sullivnh@MiamiOH.edu) 513-529-2488.