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ATSU Kirksville Institutional Review Board: Exempt Reviews

Exempt human research studies

See MO Full IRB Manual for more information

Exempt human subjects research studies are identified in 45 CFR 46.104(d)(1)-(8)

The main categories that qualify as exempt research include 45 CFR 46.104(d) 1-4: 

  • Educational settings
  • Educational tests and surveys
  • Benign behavioral interventions
  • Secondary research uses of identifiable private or biospecimens

Exempt human subjects research is defined by the low to minimal risk level to subjects. 

This type of research is exempt from most of the requirements of the Federal Policy for the Protection of Human Subjects, but is still considered research requiring an IRB review for an exemption determination.

If you are unsure whether your project is “exempt”, start by asking the following questions:

  1. Does the project meet the definition of “research”?
  2. Does the project meet the definition of a “human subject”, such as involving collecting data about living individuals, either through interaction or intervention, or use of identifiable private information or identifiable biospecimens?
  3. Is My Study Exempt Decision Chart

If you can say “yes” to both these questions, then your project is considered human subjects research requiring IRB review. 

  • Could my project fall into one of the exemption categories of research? 
    • Research on educational instruction strategies
    • Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

HHS.gov for more information on exemptions

Quality Assurance and Quality Improvement Research Studies

QA/QI studies should also be submitted using the Exempt form. 

QA/QI activities lack a systematic investigation and/or applicable generalizable knowledge outside of the specific location being assessed.  Findings are only expected to directly affect site-specific individuals, institutional practices, and/or will only help improve agency outcomes or processes.

HHS Human Subject Research Decision Charts

Not sure which type of review application is right for your research? 

Use the HHS Human Subject Decision Charts

The graphic charts are intended to aid those who need to decide if an activity is research involving human subjects that must be reviewed by an institutional review board (IRB) and whether informed consent or the documentation of informed consent can be waived under the 2018 Requirements found for the U.S. Department of Health and Human Services (HHS) at 45 CFR part 46, Subpart A.

Additional Information

Program evaluation activities are not considered human subject research when (shared from Chen 2013, Stanford):

  • They do not involve experimental or non-standard interventions;
  • Their intent is only to provide information for and about the setting in which they are conducted;
  • They are conducted as part of the standard operating procedures of the setting; and
  • They are (usually) not subject to peer review.

Using Existing Data: Research using existing data or conducted in educational settings or collecting data anonymously must receive a limited initial IRB review.

STUDENTS NOTE:  If your academic program requires submitting a complete IRB application (protocol), you should not complete the Exemption request letter.  Your study methods may be Exempt (e.g., an anonymous survey), but you will still need to complete the Initial IRB Non-Exempt Application under the "Applications and Forms" tab for academic credit.