Exempt Research
Research activities in which the only involvement of human subjects/participants will be in one or more specific categories
that are listed in section 3.1 below may be exempt from the full requirements of 45 CFR 46 or 21 CFR 56. Investigators are not
authorized to make this determination (see OPRR Reports No. 95-02, May 5, 1995, and Inter Office Memorandum to Faculty and
Administrative/Professional Staff dated 2/6/1996).
Investigators must submit a Research Exemption Request detailing their research
to the IRB. The IRB or its designee will make and document the determination of exemption based on regulatory and institutional
criteria.
PLEASE NOTE: These exemptions do not apply to research involving prisoners.
Research activities in which the only involvement of human subjects will be in one or more of the following categories are
exempt from the full requirements of 45 CFR 46:
1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
- Research on regular and special education instructional strategies
- Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods
(45 CFR 46.101(b)(1)
- Purdue University IRB guidelines extend commonly accepted educational settings to include educational settings used by Purdue
University Extension Educators.
See Guidelines to Determine Eligibility for Category 1
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 (45 CFR 46.101(b)(2)
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, if:
- The human subjects are elected or appointed public officials or candidates for public office; or
- Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be
maintained throughout the research and thereafter (45 CFR 46.101(b)(3)
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 (45 CFR 46.101(b)(4).
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; or
- Possible changes in methods or levels of payment for benefits or services under those programs (45 CFR 46.101(b)(5).
6. Taste and food quality evaluation and consumer acceptance studies:
- If wholesome foods without additives are consumed, or
- 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 (FDA) or
approved by the Environmental Protection Agency (EPA) or the Food Safety and Inspection Service (FSIS) of the U.S. Department of
Agriculture (45 CFR 46.101(b)(6)
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