Step 3: Does your research
qualify for Exemption from 45 CFR 46 (full IRB review)?
If you are conducting research with human subjects as determined in the
previous two steps you are subject to 45 CFR 46 and hence full IRB Committee
review and should complete and submit the appropriate IRB application
UNLESS the only involvement of human
subjects will be in one or more of the following six categories of exemption
not covered by 45 CFR 46:
Exempt Category #1
Research conducted in established or commonly accepted educational settings,
involving normal educational practices, such as:
- research on regular and special education instructional strategies,
or
- research on the effectiveness of or the comparison among instructional
techniques, curricula, or classroom management methods.
Note: This category may be applied to research
involving children.
Exempt Category #2
Research involving the use of educational tests (cognitive, diagnostic,
aptitude, achievement), survey procedures, interview procedures or observation
of public behavior, unless:
- Information obtained is recorded in such a manner that human subjects
can be identified, directly or through identifiers linked to the subjects;
and
- 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.
Note: Surveys on sensitive or personal topics which
may cause stress to study participants are not exempt from IRB review.
The section of this category pertaining to standardized educational
tests may be applied to research involving children. This category
may also apply to research with children when the investigator observes
public behavior but does not participate in that behavior or activity.
Note: This section is not applicable to survey or interview research
involving children.
Exempt Category #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:
- The human subjects are elected or appointed public officials or candidates
for public office.
- Federal statute(s) require(s) without exception that the confidentiality
of the personally identifiable information will be maintained throughout
the research and thereafter.
Exempt Category #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.
Examples: Existing Data, Records Review, Pathological
Specimens
HIPAA Note: Under the Health Insurance Portability
and Accountability Act of 1996 (HIPAA), researchers may obtain access
to de-identified health information without the consent of the study
subjects. De-identified health information is data that does not identify
an individual and reasonably cannot be used to identify an individual.
If your research involves de-identified health information, also complete
a De-Identification
Certification Form along with this application. (See: When
is data de-identified? on the IRB web site.)
Note: Records considered
private based on federal and state statute, including medical records
and education records, require written release by the study subject
or by the custodian of the record. Researchers are cautioned that review
of private records involving access to and/or recording of identifiable
information is not exempt from IRB Review and requires written consent
of the study subject. Existing public records do not require prior consent
of subjects to review the record.
Pathological or diagnostic specimens which are considered
waste and are destined to be destroyed can be used in research and are
considered exempt from IRB review if there are no patient identifiers
linked to the specimen and if the data is not intended to be used in
the diagnosis or treatment of a patient. (If either of these conditions
apply, consent of the research subject is required and a higher level
of IRB review is required.) Specimens retrieved as "extra"
during a clinical procedure require review at a higher level and require
written consent from the subject.
Inclusion of fetal tissue in the pathological specimens category of
exempt research is prohibited by regulation and requires IRB review.
NOTE: This Category is NOT available to individuals.
Please contact RSPP if you believe your research falls into this category.
Exempt Category #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:
- Public benefit or service programs.
- Procedures for obtaining benefits or services under those programs
- Possible changes in or alternatives to those programs or procedures
- Possible changes in methods or levels of payment for benefits or services
under those programs.
Exempt Category #6
Taste and food quality evaluation and consumer acceptance studies.
- If wholesome foods without additives are consumed
- 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.
Note: This category may be applied
to research involving children; however, University policy requires
written parental consent to include children in taste testing or
odor studies.
If your research meets the above criteria for one of the six categories
of exemption, please proceed to Step 4 to download
the exempt application for the appropriate category of exempt research.
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