Exemptions
January 2019
Guidance on Exemption Categories
Category 1
- Definition: Research conducted in established or commonly accepted educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Category 2
- Definition: Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior (including visual or auditory recording).
- Notes:
The following is not allowed under this exemption category:
- Interventions
- The collection of biospecimens
- Linking to additional personally-identifiable data
- Research with children, except for research involving educational tests (cognitive, diagnostic, aptitude, achievement) or observation of public behavior if the investigator does not participate in the activities being observed
- Related Guidance:
Category 3
- Definition: Research involving benign behavioral interventions (i.e., brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on or be offensive or embarrassing to the subjects) with adult subjects who prospectively agree to the intervention and collection of information through verbal or written responses (including data entry) or audiovisual recording.
- Notes:
The following is not allowed under this exemption category:
- Research with children
- Deception, unless prior is agreement obtained
- Physiological data collection methods (e.g., EEG; wearable devices; blood pressure monitors)
- Linking to additional personally-identifiable data
Category 4
- Definition: Secondary research uses of identifiable private information or identifiable biospecimens.
- Notes: Research involving certain datasets may not need IRB review. For more information, see UW-Madison De-Identified Publicly Available Datasets Policy for determining when publicly-available social science datasets may be used without prior IRB approval.
Category 5
- Definition:
Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of the department or agency heads, that are designed to study, evaluate, or otherwise examine:
- 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.
- Notes: The OHRP has issued additional guidance on applying this exemption.
Category 6
- Definition: 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 approve by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture (45 CFR 46.101 (b)(6) and 21 CFR 56.104 (d).
Category 7 - Not implemented at this time
- Definition: Storage or maintenance for secondary research for which broad consent is required. Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and can find that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
- Notes: The UW-Madison will not implement this category at this time because the definition and implications of Broad Consent are unclear and the tracking requirements may be burdensome and impracticable.
Category 8 - Not implemented at this time
- Definition: Secondary research for which broad consent is required. Research involving the use of identifiable private information or identifiable biospecimens for secondary research use.
- Notes: The UW-Madison will not implement this category at this time because the definition and implications of Broad Consent are unclear and the tracking requirements may be burdensome and impracticable.
FAQs
Frequently Asked Questions
Not Human Subjects Research
Research not involving human subjects
Some projects may be research studies that do not involve human subjects as defined by the Common Rule, such as research involving decedents, de-identified data or specimens, or organizational level data.
Related Guidance:
Projects that do not constitute research
Some projects fall outside the definition of research, such as such as quality improvement, quality assessment and program evaluation. If you believe that your project does not constitute research, but are required by UW-Madison policy or a publisher to obtain an IRB determination, this application type (i.e. exempt from ongoing IRB oversight as not research) is appropriate.
Related Guidance:
Glossary Terms
Exemption ARROW Terms