A human subject is a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual; or (2) identifiable private information.

• Intervention includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
• Interaction includes communication or interpersonal contact between investigator and subject.
• Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

Note Undergraduate senior thesis projects involving human subjects conducted to meet the requirement of a degree are usually considered generalizable, and require IRB review and approval.

In some cases, an activity that involves human subjects may not meet the federal guidelines for IRB review of human subjects research.

For example, a project such as a quality improvement survey or oral history documentary may involve human subjects, but is not considered “research.” Alternatively, a project may be considered research, but the existing data being analyzed has no identifiers or codes linking to identifiers and therefore the research does not involve human subjects. For more information about determining whether your project meets the criteria for human subjects research, see Does my project involve human subjects?

If your project does not meet the criteria for human subjects research, you do not need to complete an application. However, please review the criteria thoroughly before making this determination as the IRB cannot retroactively approve research.