Institutional Review Board

The Institutional Review Board is a committee of the Office of Academic Affairs

About the Institutional Review Board

The Institutional Review Board (IRB) is a University committee composed of faculty members and a community representative who is not affiliated with the institution. The IRB is responsible for reviewing all research activities involving human subjects regardless of the source of funding. The mission of the IRB is to promote and safeguard research activity that involves human subjects within the academic community.

Purpose & Mission

What is Subject to IRB Review?

All projects that involve human research subjects are subject to review by the IRB prior to the initiation of the study. To determine whether a study is subject to IRB review, the definition of human subject and the definition of research should be examined.

A human subject is a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Research is defined as “a systematic investigation, including research, development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” A systematic investigation is an activity that involves a prospective plan incorporating data collection (quantitative or qualitative) and data analysis to answer a question. Investigations designed to develop or contribute to generalizable knowledge are those that are designed to draw general conclusions, inform policy, or facilitate change in practice.

Only the IRB has the authority to grant exempt status to a study. A determination of exemption requires that the researcher complete training on the use of human subjects in research and submit a limited review application for exemption to the IRB. The federal regulations include specific categories of exemption, and any research procedures falling outside those categories must be reviewed through expedited or full review procedures.

What is Not Subject to IRB Review?

An example of a project that would not be considered human subjects research is a student project that occurs in the classroom if there is no intention of using the results for any purpose other than a class assignment. This type of project is undertaken as a learning experience to help students understand the process of conducting research, and the focus is not on producing meaningful results. In these cases, only the student and instructor have access to the results, and the project’s purpose ends when a grade is assigned. However, some class assignments are undertaken as part of a project with a broader purpose that makes them subject to IRB review. For example, if a student intends to later use data collected as part of a class assignment for a thesis project or if a student plans to share the results with an audience outside the classroom, he or she should seek IRB approval prior to initiating the data collection process. Thesis or dissertation projects conducted to meet degree requirements are subject to IRB review and approval any time human subjects are involved.

When a project is undertaken by a student as a learning exercise with the results not shared beyond the classroom, the text below is provided for use in data collection instruments.

This project is being conducted by a student as part of an exercise in learning about the research process. This data is not being collected for research purposes, and the project has not been approved by an Institutional Review Board (IRB). The data will be used solely for the course assignment, and results will not be shared beyond the classroom.

Questions about whether a project requires IRB review and other questions about the IRB process can be directed to Lisa Royalty at lisa.royalty@eku.edu, IRB Administrator.

To apply for IRB approval, please follow the procedures outlined here.