Oakland City University
Institutional Review Board
Exempt Status Criteria (from 45 CFR 46.101)
In order for a research proposal to qualify for
Exempt Status, all of the research proposal’s activities must
qualify in one or more of the following categories and meet the
criteria and conditions set forth in the category:
Categories to Qualify for Exempt Status:
(1) The research is 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 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, if the research
meets all of the following conditions:
NOTE: all three of these conditions must
apply.
(a) The information obtained is recorded in such
a manner that human subjects cannot be identified, directly or through
identifiers linked to the subjects;
AND
(b) The disclosure of the human subjects’ responses outside
the research would not reasonably place the subjects at risk of
criminal or civil liability or be damaging to the subject’s
financial standing, employability, or reputation;
AND
(c) The subjects are not under the age of 18 or members of a vulnerable
class, including prisoners, pregnant women, individuals who are
mentally disabled or economically or educationally disadvantaged.
(3) Research involving the use of educational
test (cognitive, diagnostic, aptitude, achievement), survey procedures,
interview procedures, or observation of public behavior that does
not qualify for Exempt Status under Category 2 above because the
research failed to meet any one of the conditions set forth under
Category 2 above, but only if the research meets one (1) of the
following:
(a) The human subjects are elected or appointed
public officials or candidates for public office;
OR
(b) Federal statue(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:
(a) These sources are publicly available;
OR
(b) If the information is recorded by the researcher in such a manner
that subjects cannot be identified, directly or through identifiers
linked to the subjects.
(5) Research which is conducted by or subject
to the approval of the Dean of the School or Program Director and
which is designed to study, evaluate, or otherwise examine one (1)
or more of the following:
(a) Service or public benefit programs;
OR
(b) The procedures for obtaining services or benefits under those
programs;
OR
(c) Potential changes in or alternatives to those programs or procedures;
OR
(d) Possible methods changes or levels of payment for benefits or
services under these programs.
(6) Research involving a taste and food quality
evaluation and consumer acceptance studies, and if the research
meets (1) of the following conditions:
(a) Wholesome foods without additives are consumed;
OR
(b) The food consumed 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
USDA.
IRB
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