Human Subjects Research: Institutional Review Board (IRB)

As the interpretations of research and normal classroom activities vary, questions arise on what falls within the federal guidelines of research, and activities designed to train students in research methods in the normal classroom setting. Educational activities usually do not fall within the federal definition of research as described in 45 CFR 46.102(d). However, any research conducted with the intent to either contribute to generalize knowledge or to construct knowledge related to a specific situation that will be published or presented within an academic discipline, even that originating from the classroom activity, may fall within the requirement for IRB review.

The instructor has the responsibility of ensuring students are educated on the general principles of research ethics and human subject protection. If project does need IRB review, all students involved in the project must complete CITI training (see CITI training section). Below are criteria to determine whether classroom assignments require IRB approval.

IRB Review Not Required

• The project is a class requirement, and the requirement is stated on the class syllabus.
• The project only involves members of the class.
• The project is performed within the confines of the lecture/laboratory room.
• The project carries no risk, as determined by the IRB.

Note: If research is conducted outside the confines of any classroom or laboratory, it may need to be reviewed by the IRB. Faculty may contact the IRB Chair to assist in determining if review is needed.

IRB Review is Required (if any of the following criteria is met)

• It is a graduate thesis.
• Participants are from a special population such as minors (under 18 years old), prisoners, patients, who are physically or mentally challenged individuals or pregnant women.
• Assignment requires using a setting such as prisons, nursing homes, hospitals or schools.
• Assignment focuses on topics such as alcohol/drugs, depression/suicide, learning disabilities, abortion, AIDS/HIV/sex, sexually transmitted diseases, eating disorders or psychological inventories.
• Assignment includes audio or video recording.
• Participants are directly identified through the assignment.
• Data collected will be formally presented to any audience outside of the class (e.g., conference).
• Data collected will be included in any publications.
• The research extends beyond the classroom environment.