Loyola University Maryland

Office of Research and Sponsored Programs

Human Subjects Research

How is “research” defined?

The federal definition of research is a “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge involving human subjects.” (45 CFR 46.102)  

By definition, examples of research would include (but would not be limited to) written or online surveys, in-person or telephone interviews, observations of public behavior, program or treatment evaluations, studies involving a manipulated variable, extraction of identifiable personal information from institutional records. 

What constitutes research with human subjects?

Research with human subjects involves research on living individuals “about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or identifiable private information.” (45 CFR 46.102)

What types of research need to be submitted to the IRB?

Generally research that involves contact with human subjects or obtaining data about living human beings requires review when that data will be used to generalize findings or draw conclusions. For more information on whether or not your project requires IRB approval, please review this guidance on when IRB review is needed.