What is Exempt Category Review of Research Studies?
Under federal regulations, certain types of research studies can be considered Exempt from Full Board (IRB) review. To fall under this research category, research studies must be deemed minimal risk to subjects. Minimal risk is defined by federal regulations to be...
"The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."
45 CFR 46. 102 (i)
The term "exempt" can be misleading. Exempt does not mean studies are automatically excused from IRB submission and review but rather are exempt from FULL BOARD REVIEW. At UNTHSC, all research protocols involving human subjects must be submitted to the Office of Research Compliance (OReC) for proper review and determination of review category. If a protocol is deemed Exempt by OReC and the IRB chair, the research study is no longer under IRB monitoring and the investigator does not have to report to the IRB. UNLESS...Any modification to the research protocol must be reported to the IRB as certain changes can increase risk to subject or change the type of review (Expedited or Full Board).
Most Exempt category studies reviewed at UNTHSC fall under Category (2) survey, interview, observation of public behavior or Category (4) collection or study of existing data. To access the Exempt Review Application, please follow this link or visit "IRB Forms" on our website.
UNDER CONSTRUCTION: You may access BMSC 5400 power point lecture created and given by Dr. Brian Gladue, OReC Executive Director, for more guidance on Exempt category review by following this link.
Pages in Exempt Review
- Exempt Category Review
- You are here: What is Exempt Category Review of Research Studies?
- Who decides whether or not a project has "minimal risk"?
- According to the federal regulations, which research studies fall under Exempt Category Review?
- Do research studies involving Children, Prisoners, Pregnant women and Fetuses qualify for Exempt Category Research?
- What do I submit to the IRB for an Exempt Category Research?
- How (and When) Will I know that a Protocol has been Approved?