How Do I Know if My Project Needs Institutional Review Board (IRB) Approval?

All research that involves human subjects, including some student projects, conducted under the auspices of IU South Bend or on the IU South Bend campus must be reviewed and approved by the IU South Bend Institutional Review Board for the Protection of Human Subjects.

Is it Research?

The Department of Health and Human Services (DHHS) defines research as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”

Intervention includes “both physical procedures by which data are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes.”

Does it Involve Human Subjects?

Human subject is defined as “a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”

What About Student Projects?          

Some student projects require Institutional Review Board review. However, classroom assignments that do not involve risk, and are not intended to, nor likely to, lead to generalizable results, may not need to be reviewed.

Student studies that fit ANY of the descriptions below must be reviewed:

A.     Student projects that may place subjects at risk,

B.     Student projects that are undertaken with the intent of adding to generalizable knowledge,

a.      including ANY public presentation beyond the classroom type setting

b.      including funded studies

c.      including written presentation beyond the classroom/peer setting

C.    Student studies that are undertaken involving special populations including pregnant women, fetuses, prisoners, minors, or human in vitro fertilization. 

Instructors are responsible for screening individual student research projects and making an initial determination as to whether the project may fall in the category of research. You can use the Student Research Checklist to help in this process. Institutional Review Board approval must be obtained prior to initiation of the research.