Expedited and Exempt Review
Categories
Expedited
Review Categories
(Federal Policy
46.110)
RESEARCH IN THE FOLLOWING (MINIMAL
RISK) CATEGORIES ARE ELIGIBLE FOR APPROVAL ON THE BASIS OF A
REVIEW BY THE IRB CHAIR AND SELECTED IRB MEMBERS.
The category number preceding each
description is the number to claim on question 12 on the
application form.
- Collection of hair and nail
clippings, in a non-disfiguring manner, deciduous teeth, and
permanent teeth if patient care indicates a need for
extraction.
- Collection of excreta and
external secretions including sweat, uncannulated saliva,
placenta removed at delivery, and amniotic fluid at the time of
rupture of the membrane prior to or during labor.
- Recording of data from
subjects 18 years of age or older using non-invasive procedures
routinely employed in clinical practice. This includes the use
of physical sensors that are applied either to the surface of
the body or at a distance and do not involve input of matter or
significant amounts of energy into the subject or an invasion
of the subject's privacy. It also includes such procedures as
weighing, testing sensory acuity, electrocardiography,
electroencephalography, thermography, detection of naturally
occurring radioactivity, diagnostic echography, and
electroretinography. It does not include exposure to
electromagnetic radiation outside the visible range (e.g.,
X-rays and microwaves).
- Collection of blood samples by
venipuncture, in amounts not exceeding 450 milliliters in an
8-week period and no more than two times a week, from subjects
18 years of age or older and who are not pregnant.
- Collection of both supra- and
subgingival dental plaque and calculus provided the procedure
is not more invasive than routine prophylactic scaling of the
teeth and the process is accomplished in accordance with
accepted prophylactic techniques.
- Voice recordings made for
research purposes such as investigation of speech defects.
- Moderate exercise by health
volunteers.
- The study of existing data,
documents, records, pathological specimens, or diagnostic
specimens (e.g. where identifiers could link data to particular
subjects).
- Research on individual or
group behavior or characteristics of individuals such as
studies of perception, cognition, game theory, or test
development, where the investigator does not manipulate
subjects' behavior and the research will not involve stress to
subjects.
- Research on drugs or devices
for which an investigational new drug exemption or an
investigational device exemption is not required.
Exempt Review
Categories (Federal Policy
46.101b)
THE FOLLOWING CATEGORIES ARE
EXEMPT FROM FULL IRB REVIEW, BUT MUST BE REVIEWED BY THE CHAIR OF
THE IRB.
The category number preceding each
description is the number to claim on question number 13 on the
application form.
1. INSTRUCTIONAL STRATEGIES IN
EDUCATIONAL SETTINGS
Research conducted in established
or commonly accepted educational settings are exempt from full IRB
review if they involve normal educational practices such
as:
- research on regular
and special educational instructional strategies,
or
- Research on the effectiveness
of, or the comparison among, instructional techniques,
curricula, or classroom management methods.
[This category may be
applied to research involving children. All other research on
children requires full review.]
2. SURVEYS/INTERVIEWS;
STANDARDIZED EDUCATIONAL TESTS; OBSERVATION OF PUBLIC
BEHAVIOR
Research involving the use of
educational tests (cognitive, diagnostic, aptitude, achievement),
survey procedures, interview procedures or observation of public
behavior, are exempt from full IRB review if:
- Information obtained
is recorded in such a manner that human subjects cannot be
identified, directly or through identifiers linked to the
subjects, and
- disclosure of the human
subjects' responses outside the research could not reasonably
place the subjects at risk of criminal or civil liability or be
damaging to the subject's financial standing, employability, or
reputation.
- Surveys or interviews on
sensitive or personal topics which may cause stress to study
participants are not exempt from IRB review.
- Surveys or interviews with
children are not exempt.
- Needs assessment or evaluation
data intended to remain within the Augsburg community and not
circulated on the website, in written documents, or in public
presentations.
3. PUBLIC OFFICIALS;
SURVEYS/INTERVIEWS; EDUCATIONAL TESTS; OBSERVATION OF PUBLIC
BEHAVIOR
Research involving the use of
educational tests (cognitive, diagnostic, aptitude achievement),
survey procedures, interview procedures, or observation of public
behavior if:
- the human subjects
are elected officials or candidates for public office;
or
- federal statute(s) require(s)
without exception that the confidentiality of the personally
identifiable information will be maintained throughout the
research and thereafter.
4. EXISTING DATA; RECORDS REVIEW;
PATHOLOGICAL SPECIMENS
Research involving the collection
or study of existing data, documents, records, pathological
specimens are exempt from full IRB review, if these sources are
publicly available or if the information is recorded in such a
manner that subjects cannot be identified directly or through
identifiers linked to the subjects.
- [Records considered
private based on federal and state statute, including medical
records and education records, require written release by the
study subject or by the custodian of the record. Researchers
are cautioned that review of private records involving access
to and/or recording of identifiable information is not exempt
from IRB review and requires written consent of the study
subject. Existing public records do not require prior consent
of subjects to review the records.]
- [Pathological or
diagnostic specimens which are considered waste and are
destined to be destroyed can be used in research and are
considered exempt from IRB review if there are no patient
identifiers linked to the specimen and if the data is not
intended to be used in the diagnosis or treatment of a patient.
(If either of these conditions apply, consent of the research
subject is required and a higher level of IRB review is
required.) Specimens retrieved as extra during a clinical
procedure require review at a higher level and require written
consent from the subject.]
- [Inclusion of fetal tissue
in the pathological specimens category of exempt research is
prohibited by regulation.]
5. PUBLIC SERVICE PROGRAMS;
DEMONSTRATION PROJECTS
Research and demonstration
projects are exempt from full IRB review if they are conducted by,
or subject to, the approval of department or agency heads, and
which are designed to study, evaluate or otherwise
examine:
- public benefit or
service programs;
- procedures for obtaining
benefits or services under those programs;
- possible changes in, or
alternatives to, those programs or procedures; or
- possible changes in the
methods or levels of payment for benefits or services under
those programs.
6. TASTE TESTING AND FOOD QUALITY
EVALUATION
Taste and food quality evaluation
and consumer acceptance studies:
- if wholesome foods
without additives are consumed (all food tested must be GRAS,
or Generally Recognized As Safe); or
- if 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 Inspection Service or the
U.S. Department of Agriculture.
[This category may be
applied to research involving children; however, written
parental consent to include children in taste testing studies
is required.]
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