IRB Exemption Guidelines

Certain broad categories of research projects involve human participants that do not meet the definition under the regulations are “exempt” from IRB review.

“Exempt” in this context means that a project is not subject to, or is exempted from the requirements of the regulations spelled out in 45 CFR 46.

Federal regulations permit the principal investigator to make an initial judgment as to whether the project is exempt; however, on the IRB must make the final determination that the activity is eligible for exemption.

To qualify research as “Exempt,” the study must fall within the federal regulatory categories and satisfy all Minot State University institutional requirements. Only the IRB may determine when research is exempt or requires an expedited or full board review. Therefore, researchers must submit an application it the IRB requesting exempt status to the to ensure the research meets the criteria for Exempt status. Upon review, the Faculty or Staff submitting the application will receive either a notice of Exempt Status or request for additional information required in the form of an Expedited or Full Board Review.

Exemption Categories

The following CANNOT be classified as Exempt Research:

  •  research involving prisoners;
  •  surveys or interviews of children;
  •  observation of children when the investigator will interact with them;
  •  research procedures, otherwise eligible for exemption IF:

1. the information is recorded in such a way that the identity of individuals can be identified either directly or through identifiers linked to the individuals


2. disclosure of participants’ responses could reasonably place them at risk of criminal or civil liability or be damaging to an individual’s financial standing, employability, or reputation;

  • observation of behavior that takes place in settings in which participants have a reasonable expectation of privacy;
  • research techniques which expose participants to discomfort or harassment beyond levels of encountered in daily life (i.e. greater than minimal risk);