Certain research activities involving human subjects have been given exemptions from IRB full board review through either federal and/or state regulations.
If an investigator believes that the research activities being proposed fall into one of the exemption categories, the protocol should be submitted to the IRB for exemption review (see the flow chart). The decision to approve a project submitted for exemption review will be made by the Chair of the IRB or his/her designee and two additional IRB members.
All IRB decisions regarding approval, disapproval, or required modifications will be communicated to the Principal Investigator in writing.
The purpose of the exemption review process is to provide assurance that a particular research project does indeed meet the criteria for exemption.
All of the research activities in a project that involve human subjects must be exempt in order for the project to be submitted for exemption review. If even one activity is not exempt, the project is not exempt.

Pregnant women, children (persons who have not attained the legal age for consent to treatments or procedures involved in the research), and prisoners are considered vulnerable populations.
Any project involving vulnerable populations does not qualify for exemption review and must undergo either expedited or full board review.

If all research activities in the project fit one or more of the following four categories, then that research project may qualify for exemption review.
(1) Research conducted in established or commonly accepted educational settings, involving normal educational practices. This includes research on regular and special education instructional strategies, or research on the effectiveness of, or the comparison among, instructional techniques, curricula, or classroom management methods.
(2) Research involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observations of public behavior unless:
(a) The information is recorded in such a manner that subjects can be identified, directly or through identifiers linked to the subjects; and
(b) Any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
(3) Research involving the collection or study of existing data, documents and records, if these sources are publicly available or if the information is recorded in such a manner that the subjects cannot be identified, directly or through identifiers linked to the subjects, qualifies for exemption review.
If the project does not involve vulnerable populations and all activities fit into one or more of the above categories, then the investigator should submit the protocol to the IRB for exemption review. Even if the IRB determines that a study is indeed exempt, the investigator may still request a full board review. This might be done to address ethical questions posed by the investigator or reviewers, or it might be done because of potential controversy or publicity associated with the project.
If the project does involve vulnerable populations and/or all activities do not fit into one or more of the above categories, then proceed to Question 4, to determine if your protocol would qualify for expedited review or need to be submitted for full board review.