Human Subjects in Research
This is a guide to help investigators determine if their project is considered human subjects research as defined by the Department of Health and Human Services (DHHS): Determination Form
- Activities that do meet the definition of "human subject research" will require submission of an Initial Review Form (below).
- Activities that do not meet this definition do not require IRB submission. Please note that you must still conduct all activities in an ethical manner. Please consult with your academic department regarding fulfillment of your ethical obligations.
Any research that involves human subjects, whether funded or not, that is undertaken by a WIU faculty, academic staff or student or supported by Western Illinois University, must be reviewed by the Institutional Review Board (IRB). Approval must be granted by the IRB prior to collecting data from any human subjects for research purposes or soliciting subjects for a research study. For detailed information on human subjects research, please see the Policy and Procedure for Human Subjects manual .
It is the policy of Western Illinois University that all individuals engaged in research involving human participants must complete an educational program related to the responsible conduct of research prior to initiation of a research project. For detailed information on research training, please see Procedures for Submitting Protocols .
IRB protocols that do not require full board review may be submitted at anytime. Protocols for full review by the convened IRB must be received in the Office of Sponsored Projects no later than 4:30 p.m. two weeks before the meeting date. For more information about Western Illinois University’s Institutional Review Board and meeting times, please see the
Membership and Meeting Info page
. For further instructions on how to complete the WIU IRB form, please see
Review of Research Instructions
|WIU IRB Forms|
Review and Monitoring
The WIU IRB approves human subject research at the following review levels:
- Exempt Review - To qualify, research must fall into one of six federally-defined exempt categories. These categories present the lowest amount of risk to potential subjects because they involve either collection of anonymous or publicly-available data, or conduct of the least potentially-harmful research experiments.
- Expedited Review - To qualify for an expedited review, research must fall into one of nine federally-defined expedited categories. These categories involve collection of samples and data in a manner that is not anonymous and that involves no more than minimal risk to subjects. Research projects that qualify for expedited review must include participant informed consent.
- Full Review - A project that involves greater than minimal risk requires approval by the Institutional Review Board Committee. Research that requires full committee review can include: Non-exempt research that involves children or other vulnerable populations, research that involves experimental drugs or devices, research that involves invasive procedures, or survey research that involves sensitive questions or information about sexual practice or illegal behavior.
- Review and Monitoring – This form has a three-fold purpose:
- continuation on a protocol that has been submitted and approved by the IRB,
- modification on a protocol that has been submitted and approved the IRB,
- conclusion or closing of a protocol that has been submitted and approved by the IRB.
If you have questions please contact:
Office of Sponsored Projects
Sherman Hall 320
1 University Circle
Macomb, IL 61455