What is Human Subjects Research at Missouri State University?

When students, staff, and/or faculty conduct research at Missouri State University that involves human participants, an application to the Institutional Review Board (IRB) is required by University policy.  Not all things that look like research actually are.  Research is defined as:

A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge [45 CFR 46.102(d)].  

• A Systematic investigation, in turn, is any activity that utilizes scientific methods (either quantitative or qualitative) in an orderly, iterative process of data gathering.  These methods may be experimental, quasi-experimental, or pre-experimental in nature and may or may not involve random selection and/or random assignment.  
• Generalizable knowledge involves any information generated from data collected to describe, inform, generate or test hypotheses that will be shared with others in any public or semi-public venue other than closed meetings and/or the classroom setting.   It also includes dissemination through things like local or state newsletters or posting on the Internet such that a wider audience could access the information freely.

While it may seem obvious, you have to be working with “human participants” to necessitate an application to the IRB.  A Human Participant is defined as:

Living individual(s) 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" [45 CFR 46.102(f)].  

Thus, if you are conducting research by working with human participants, then you should complete and submit an IRB application.

Federal-Wide Assurance

The university has a Federal Wide Assurance (FWA) number from the Office of Human Research Protections (OHR) in the U.S. Department of Health and Human Services.  This number (FWA: 00004733) is often required on the cover page of applications whenever the proposed project involves the use of human subjects.  Please note that approval is required from the University's Institutional Review Board (IRB) for the Protection of Human Subjects on these projects.  Review of program guidelines is important because some agencies require prior approval from the IRB.

See other Institutional Data.