Exempt research is so named because it is exempt from some of the federal regulations; however, it is not exempt from state laws, institutional polices, or the requirements for ethical research. The ֱ Boulder IRB makes determinations of exemption.


To qualify for exemption, the entirety of the research must fit into one or more of the Exempt Categories as described in . While the regulations define eight categories, most—if not all—exempt research at ֱ Boulder falls within Categories 1–4. The information on this page is limited to Categories 1–4. If you believe your research fits into one of the categories not described here, please contact the IRB for assistance.

Informed consent in Exempt research

The requirement to document informed consent does not apply to Exempt research.However, sinceinformed consent is one of the most important aspects of research ethics, the ֱ Boulder IRB requires a consent process for all research involving an interaction with participants, whether it be in-person or remote.

Informed consent is one of the founding principles of research ethics. Its intent is that human participants can enter research freely (voluntarily) with full information about what it means for them to take part, and that they give consent before they enter the research. It is important to understand that even though consent may not be documented with a signature, as is the case with much of exempt research, consent is still being obtained. For example, when a consent script that contains basic elements of consent is used for a phone survey, the participant may choose whether or not to proceed with the survey based on the information provided. That is consent; it is not implied.

In-person consent

When there is in-person interaction between the PI and a participant, the PI should provide a physical copy of the consent information. The PI can explain/discuss the consent information with participants and obtain verbal confirmation of consent or participants can sign the consent form. Use the Exempt In-Person Consent Template for research that involves in-person interaction.

Remote consent

Remote interaction includes online surveys or interviews, telephone surveys or interviews, and interactions that occur via video calls (Zoom, etc.). Participants should be provided the consent information before their participation begins. This can be including the consent text as the first item in an online questionnaire with a “click to consent” option or reading the consent information to participants and obtaining a verbal confirmation of consent from participants. Use the Exempt Remote Consent Template for research that involves remote interaction.

Who can participate in Exempt research?

Federal regulations limit which special populations can participate in Exempt research:

  • Pregnant women can participate in research in any Exempt Category.
  • Prisoners cannot participate in any Exempt Category (i.e.prisoners cannot be a target population).
  • Children may participate in Categories 1 and 4 without limitations and in Category 2(i) and 2(ii) if the research only involves educational tests or the observation of public behavior when the investigator does not participate in the activities being observed.

The ֱ Bouder IRB created templates specific to exempt research: Exempt Protocol, Exempt In-Person Consent, Exempt Remote Consent. These documents must be used when creating an Exempt Initial Application. There are no deadlines for submitting Exempt research, but no research activities can occur until you receive an Exempt Determination letter from the IRB.

Use the to help you decide if your research qualifies for exemption. Note: the results are not an official IRB determination.

    A note about the verbiage used on this page. The use of the term “subject” is limited to language taken directly from the federal regulations. The ֱ Boulder IRB encourages the use of the term “participant,” which is used in all other areas of this page.