Research activities in which the ONLY involvement of human
subjects will be in one or more specified categories are eligible
for exemption certification. Note, however, that the exemption
categories (1 through 6 below), do NOT apply when the
research activities include the following:
- Prisoners, fetuses, pregnant women or human in
vitro fertilization.
- The review of medical records; if the information
is recorded in such a way that subjects can be identified,
directly or through identifiers liked to the subjects.
- Survey or interview techniques which include minors
as subjects.
- Research involving the observation of the public
behavior of minors.
- Techniques which expose the subject to discomfort
or harassment beyond levels encountered in daily life.
- The deception of the subjects.
Exemption Categories:
- Research conducted in established or commonly accepted
educational settings, involving normal educational practices,
such as (I) research on regular and special educational
instructional strategies, or (ii) research on the effectiveness
of or the comparison among instructional techniques, curricula,
or classroom management methods.
- Research involving the use of educational tests (cognitive,
diagnostic, aptitude, achievement), survey procedures, interview
procedures or observation of public behavior, unless: (I)
subjects can be identified, directly or through identifiers
linked to the subjects; and (ii) any disclosure of the human
subjects’ responses outside the research could reasonably place
the subjects at risk of criminal or civil liability or be
damaging to the subjects’ financial standing, employability, or
reputation.
- Research involving the use of educational tests (Cognitive,
diagnostic, aptitude, achievement), survey procedures, interview
procedures, or observation of public behavior that is not exempt
under category (2.) of this section, if: The human subjects are
elected or appointed public 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.
- Research involving the collection or study of existing data,
documents, records, pathological specimens, or diagnostic
specimens, if these sources are publicly available or if the
information is recorded by the investigator in such a manner
that subjects cannot be identified, directly or through
identifiers linked to the subjects.
- Research and demonstration projects which are conducted by
or subject to the approval of government department or agency
heads, and which are designed to study, evaluate, or otherwise
examine: (I) Public benefit or service programs; (ii) procedures
for obtaining benefit or services under those programs; (iii)
possible changes in or alternatives to those programs or
procedures; or (iv) possible changes in methods or levels of
payment for benefits or services under those programs.
- Taste and food quality evaluation and consumer acceptance
studies, (I) if wholesome foods without additives are consumed
or (ii) 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 and Inspection Service of the U.S. Department of
Agriculture.
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