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.

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

AND

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);

Criteria for Protection of Human Subjects in Exempt Research

A research project that has received an Exempt designation is not exempt from protection of the human subjects. All of the following criteria to protect human subjects must be met:

  1. The PI (or Faculty/Staff investigator or supervisor) assures that all those persons listed on the application who are involved in the research have completed in IRB human subjects training requirements. Online training is available, at no cost to the investigator, through CITI (https://citiprogram.org/).
  2. The PI assures that human subjects will voluntarily consent to participate in the research when appropriate (e.g. surveys, interviews, interactions with participants) and will provide subjects with pertinent information (e.g. the activity involves research, a description of procedures, that participation is voluntary, risks and benefits, contact information for PI, etc.). Such information should be included in the instructions on the survey.
  3. The PI assures that human subjects will be selected equitably, so that risks and benefits of the research are justly distributed;
  4. The PI assures that the IRB will be immediately informed of any information or unexpected or adverse events that would increase the risk to the human subjects and cause the category of review to be upgraded to Expedited or Full
  5. The PI assures that the IRB will be immediately informed of any complaints from participants regarding their risks and
  6. The PI assures that confidentiality and privacy of the subjects and the research data will be maintained appropriately to ensure minimal risk to subjects, and there are adequate provisions are in place to maintain the confidentiality of the data if there is any recording of identifiable

The PI acknowledges these criteria with their signature on the Exempt Screening Form and upon receiving notification from the IRB of exempt status.