Exemption Review Categories
Research that exposes participants to minimal risk, or no risk at all, may be considered exempt from the need for ongoing IRB review and approval. Federal law details six categories of exempt research. See details of each exemption category below.
The following types of studies MAY qualify for a determination of exemption by the IRB:
- Studying educational methods
- Interviewing public figures
- Utilizing publicly available data sets
- Utilizing specimens of human tissue stripped of identifiers
Please note: According to federal regulations, the IRB (not the researchers themselves) must make final determination for exemption categories and this decision must be documented within the eResearch system.
Please carefully consider the 'fit' between your proposed research project and the proposed exemption category. Exemption categories are very narrow in their scope and the research must clearly fall within the boundaries of the definition. If the IRB determines that your project does not qualify for an exemption, you may be required to provide additional information when completing your application.
Please contact the IRB Office if you have further questions about qualifying for an exemption. Student applicants conducting course-based research should first consult their faculty advisor before contacting the IRB.
EXEMPTION #1 (45 CFR 46.101(b)(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.
EXEMPTION #2 (45 CFR 46.101(b)(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 that could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
EXEMPTION #3 (45 CFR 46.101(b)(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 (b)(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.
EXEMPTION #4 (45 CFR 46.101(b)(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.
EXEMPTION #5 (45 CFR 46.101(b)(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.
EXEMPTION #6 (45 CFR 46.101(b)(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.