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Exempt Research
What Does "Exempt" Mean?
Exempt research is research that is not excluded by certain
restrictions on subject populations (for example, pregnant women,
prisoners, some research with children) and that meets one or more of
the following six exemption categories:
Exemption Categories
- 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
- 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.
- 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) 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 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.
- 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.
Eligibility Criteria
Restrictions on Subject Population
An exemption cannot be recognized for research using the following
subject populations:
- Prisoners
- Pregnant woman (when pregnant woman are the targeted subject
population.)
- Exemptions are not available for some research with
children.
Restrictions on Deception
Projects that include deception of subjects are not eligible for
exemption.
Children as Subjects
Some of the exemption criteria cannot be used if the proposed
subject population includes children.
- Research involving survey or interview procedures may not be
exempt.
- Observation of public behavior is not exempt if the researchers
interact with the children.
Procedures for Determining Exemption
For research involving human subjects as defined above, a
determination of eligibility for exemption should be made either by
the Chairperson of the IRB or designee.
For questions, please call the IRB office at (202) 687-1506. Please
note that an informed consent process may be required even if a
project is determined to be eligible for exemption.
Ongoing review is not required once a determination of exemption
is made, unless the research is changed so that it no longer meets
the exemption criteria.
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