[D153.0000] Exemption Decision Charts

Some activities that do not meet the regulatory definitions of research and/or human subjects may not require IRB review. See the "What Needs IRB Review" page and/or submit a Not Human Research (NHR) Determination Form for an official ruling on whether an activity is human subject research requiring IRB review.
Researchers may not make a self-determination that their research qualifies for Exempt review. See the following Exempt Category Charts, refer to the ORI Exempt Review Decision Tool, and/or contact the UK Office of Research Integrity (ORI).
In order for the research to be eligible for exemption, the only involvement of human participants in the research must fall into one or more of the exemption categories.

Does the activity qualify as Not Human Research per NIH Secondary Chart or NHR Form? No; Refer to Exempt Category Charts (1-6); Do all research activities fit 1 or more of the exempt categories used at UK? No; Refer to OHRP Chart 8: Expedited Review.

Subpart B: Studies Involving Pregnant Women, Fetuses, & Neonates are Eligible for Exemption Under All 8 Categories
Subpart C: Exemptions Do Not Apply to Research Involving Prisoners Except “for Research Aimed at Involving a Broader Subject Population that Only Incidentally Includes Prisoners.”
Subpart D: Children are allowed in categories 1,4,5,6,7, & 8; Limitations & Exclusion of Children in Category 2 & 3

_{2020: UK ORI Exempt Decision Charts are based solely on the current interpretation of the revised Common Rule regulation (absent federal guidance or review). Select charts adapted with permission from Cornell University IRB. Contact}_{Belinda Smith}_{with questions.}

If the answer is no to any question, refer to OHRP Chart 8: Expedited Review. Is the research being done in an established or commonly accepted setting? Yes; Does the research involve normal educational practices? Yes; Is the research unlikely to adversely impact students' opportunity to learn? Yes; Is the research unlikely to adversely impact the assessment of the educators? Yes; Exempt under Category 1

Visual of steps for application of survey/interview category

Benign Behavioral Interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing.
This exemption allows for the intervention to be distinct from the data collection method.

Visual of steps for application of benign behavioral interventions categories

Some activities may not meet the regulatory definitions of research and/or human subjects.
- See the DHHS ORI Coded Private Information or Specimens Use in Research, Guidance (2008)
- Submit the Not Human Research (NHR) Determination Form for an official ruling on whether your activity is human subject research requiring IRB review.
Secondary Research: This exemption refers to re-using identifiable information and identifiable biospecimens that are collected for some other “primary” or “initial” activity.

Visual of steps for application of secondary research

*Contains identifiable information like names, emails, and other HIPAA identifiers. DNA is not currently considered identifiable.

**Open access data or commercially purchased data or specimens (does not include applications where access is not guaranteed or if qualifications are required.

^#No code links where the investigator has access to the key.