Determining What Level of Review to
Apply For:
Exempt Studies:
These are studies that are exempt from Institutional
Review Board review. The application must
demonstrate:
1. The research is minimal risk,
and
2. Fits
into one of the exempt categories:
a. Research on instructional
strategies that is conducted in established
or commonly accepted educational settings;
b. Research (except
research with minors) including
the use of educational tests (cognitive,
diagnostic, aptitude, achievement), survey
procedures, interview procedures, or
observation of public behavior;
c. Research involving the collection
or use of existing data, if these sources
are publicly available, or the information
is recorded by an investigator in such a
manner that subjects cannot be identified;
d. Research and demonstration
projects, which are conducted by or subject
to the approval of Department or Agency
heads;
e. Taste and food quality evaluation
and consumer acceptance studies, if
- Wholesome food without
additives, 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 FDA, or approved by the EPA or
the Food Safety and Inspection
Service of the U.S. Department of
Agriculture.
Expedited Studies:
These studies may be reviewed by the Institutional
Review Board through expedited review procedures.
The application form must demonstrate:
1. No more than minimal risk to
subjects, and
2. Involve
only procedures listed in one or more of the
following categories:
a. Collection of hair and nail samples
b. Collection of excreta and external
secretion
c. Recording of data from subject 18
years of age or older using non-invasive
procedures
d. Collection of blood samples in
minimal amounts
e. Collection of dental plaque and
calculus
f. Voice recording
g. Moderate exercise by healthy
volunteers
h. Study of existing data
i. Research on an individual or
group behavior that involves no manipulation
of the subjects and is not stressful; and
j. Certain kinds of research on
drugs and devices
Note: Minimal risk means that the
probability and magnitude of harm or discomfort
anticipated in the research setting is not greater
than that ordinarily encountered in daily life or
during the performance of routine physical or
psychological tests.
Full Review
Studies: These studies either involve more
than minimal risk and/or are being conducted with
vulnerable populations.
1.
More than minimal risk to subjects, and/or
2. Research conducted with certain
vulnerable populations
Examples:
a. Certain types of research with
children, pregnant women, fetuses, and other
vulnerable populations
b. Research involving prisoners
c. Research that involves experimental
drugs or devises
d. Research that involves invasive
procedures
e. Survey research that involves
sensitive questions or is likely to be
stressful for the subject.
Note: More detail regarding
categorization is available on the web at the OHRP
web site on the sidebar.
