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. All research protocols involving human subjects must still be submitted to the North Texas Regional IRB for proper review and determination of review category. If a protocol is deemed Exempt, 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 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.

 

 

Pages in Exempt Review

Exempt Category Review

What is Exempt Review

Who decides whether or not a project has “minimal risk”

Which Research Studies fall under Exempt Category Review

Do studies involving Children, Prisoners, Pregnant women and Fetuses qualify

What do I submit

How will I know that a Protocol has been approved

This page was last modified on December 21, 2017