Per 45 CFR 46, a human subject is “a living individual about whom an investigator (whether professional or student) conducting research:  

• Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
• Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”1

It is NIH’s policy that researchers involved in any study that involves human subjects must provide certification of the completion of an education program in the protection of human subjects.

The Office of Extramural Research (OER) provides resources and training supporting researchers to access and understand information for determining whether research involves human subjects and/or is subject to federal regulations.