IRB EXEMPTION
CATEGORIES
Revised
to comply with Federal Common Rule, August 19, 1991)
Please remember that exempt is
defined as being exempt from further review and
approval beyond the IRB Manager, or one of the two
IRB Co-Chairs. It does not mean that your proposed
research project is exempt from being reviewed.
The PI may suggest an Exempt Category on the
protocol application; however, the final
determinations are made by the IRB Office ONLY
The following exemption
categories do not apply to research involving
prisoners, fetuses, or pregnant women, but to all
other research with human subjects.
1.
Research conducted in established or commonly
accepted educational settings, involving normal
educational practices, such as (a) research on
regular and special education instructional
strategies, or (b) research on the effectiveness or
the comparison among instructional techniques,
curricula, or classroom management methods.
2.
Research involving the use of educational tests
(cognitive, diagnostic, aptitude, achievement),
survey procedures, interview procedures or
observation of public behavior, unless: (a)
information obtained is recorded in such a manner
that human subjects can be identified, directly or
through identifiers linked to the subjects;
AND
(b) 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.
This exemption category for
research involving survey or interview procedures or
observation of public behavior does not apply to
research with children, except for research
involving observations of public behavior when the
investigator(s) does not participate in the
activities being observed.
3.
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 paragraph (2) if: (a) the human subjects are
elected or appointed public officials or candidates
for public office; or (b) the research is conducted
for the Department of Justice under Federal statute
42 U.S.C. 3789g, or for the National Center for
Education Statistics under Federal statute 20 U.S.C.
12213-1, which provide certain legal protections and
requirements for confidentiality.
4.
Research involving the collection or study of
existing data, documents, records, pathological 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.
5.
Research and demonstration projects which are
conducted by or subject to the approval of
department or agency heads, and which are designed
to study, evaluate, or otherwise examine: (a) public
benefit or service programs; (b) procedures for
obtaining benefits or services under those programs;
( c ) possible changes in or alternatives to those
programs or procedures; or (d) possible changes in
methods or levels of payment for benefits or
services under those programs.
6.
Taste and food quality evaluation and consumer
acceptance studies, if (a) wholesome foods without
additives are consumed or (b) 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 U.S.
Environmental Protection Agency or the Food Safety
and Inspection Service of the U.S. Department of
Agriculture.
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