It
is important to remember that the investigator may not determine on his/her own that the proposed research is exempt from
further review. An application must be
submitted to the IRB.
RESEARCH ACTIVITIES THAT MAY BE EXEMPT
FROM FURTHER REVIEW
Research
involving children*, fetuses, prisoners, mentally disabled persons, or other adult
subjects of diminished autonomy is subject to special restrictions. For adult subjects of undiminished autonomy,
capable of making a truly voluntary and uncoerced
decision whether or not to participate as subjects in research, the categories
of research exempt from further review requirements are:
1) Research conducted in established or
commonly accepted educational settings involving normal educational practices,
such as:
(i) research on
regular and special education instructional strategies; or
(ii) research on the
effectiveness of 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:
(i) information
obtained is recorded in such a manner that human 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.
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) of this section, if:
(i) the human
subjects are elected or appointed public officials or candidates for public
office; or
(ii) federal
statute(s) require(s) without exception that the confidentiality of the
personally identifiable information will be maintained throughout the research
and thereafter.
4) 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.
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:
(i)
public
benefit or service programs;
(ii) procedures for
obtaining benefits 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.
6)
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.
*When the human subjects are children, only five of the above categories apply. Exemption 2 (for research involving survey or interview procedures or observations of public behavior), does not apply to research with children, except for research involving observation of public behavior when the investigator(s) do not participate in the activities being observed.
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