Institutional Review Board - Research Project Categories

Once it has been determined that a research project falls under the purview of the Institutional Review Board, it is generally reviewed under one of two categories, Category II (Expedited Review) and Category III (Full Review). The review procedures for each of these are described below. Each researcher should make the initial determination regarding the appropriate category of review, although the Institutional Review Board may require review under another category. The researcher can always request a higher level of review than that required.

Project categories, along with examples of the types of projects included in each category are as follows:

Project Category I (Class-related assignment & Exempt Reviews). Please note that only the "Instructor Exemption for Class Projects" form, along with a class roll, should be submitted to the IRB for review.

Instructor Exemption for Class Projects Form

The course instructors are responsible for completing the Instructor Exemption for Class Projects form and forwarding this, together with the class roll, to the IRB, Gregory Hall, room 456. The exemption is valid only for the academic semester during which the class project will be conducted.

Approval for Classroom Activity

Course instructors should review and approve the Approval for Classroom Activity form for each student, and should maintain a copy of this form in their class records. These applications are only for the use of the instructors - the IRB does not review them.

 Class-related Informed Consent Letter (sample)

Instructors must review and approve the informed consent procedures for all class-related projects. A sample consent form is provided to assist instructors with this process.

Project Category II (Expedited Review) This research generally does not require written documentation of informed consent, but oral consent is required for all research involving direct interaction with subjects. All research in public and private schools primary and secondary schools requires written permission of the school district.

Some relevant examples of research that involves a Category II review are as follows:

Anonymous, mail or telephone surveys on innocuous topics
Anonymous, non-interactive, non-participating observation of public behavior
Educational research involving no interaction with students; e.g., regular classroom activity
Research involving the use of educational tests such as cognitive, diagnostic, personality, aptitude, and achievement tests
Research involving the use of educational records if information taken from these sources is provided to the researcher in such a manner that subjects cannot be identified
Research on individual or group behavior of normal adults where there is no psychological intervention, physiological intervention or deception
Interviews and interactive surveys on non-sensitive topics (i.e. taste and food quality evaluation and consumer acceptance studies)

The Institutional Review Board may require full review of any research submitted or approved under expedited review.

Project Category III Project Category III (Full Review) For all research involving human participants who have been determined to be "at risk," written documentation of legally effective informed consent is required. Research on minors or subjects incompetent to give consent (e.g., certain clinical populations) requires permission by a parent or legal guardian. Deception research will only be approved if it meets certain conditions (e.g., debriefing).

Some relevant examples of research that involves a Category III review are as follows:

Research which might put subjects at risk  
Research involving psychological or physiological intervention
Non curricular, interactive research in schools 
Research involving deception that might have adverse effects on the subjects
Interviews or surveys on sensitive topics
Research on special populations; e.g. minors, prisoners, and the mentally incompetent
Research conducted outside the United States, regardless of the procedures involved
Research
involving collection of biomedical materials such as blood or DNA samples or research involving invasive procedures

The Institutional Review Board may require full review of any research submitted or approved under expedited review.