Defining Human Subjects Research

To understand what is meant by "human subjects research" under the regulations, it is helpful to begin by reviewing the definitions provided by the regulations.

After reviewing these definitions, if you are still unsure if your project falls under the regulations, do not hesitate to contact the HRPP office.

Federal Regulations Definitions


A systematic investigation, including research development, testing and evaluation designed to develop or contribute to generalizable knowledge.

Human Subject

A living individual about whom an investigator conducting research:

  1. Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies or analyzes the information or biospecimens.

  2. Obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens.

Defining the Concepts

Unfortunately, these definitions are not so straightforward and they often confuse rather than help. So, let's dig a little deeper and define the concepts within those definitions.

Is It Research?