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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, please do not hesitate to contact the IRB Office

The federal regulations in 45 CFR 46.102, give the following 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 (whether professional or student) conducting research obtains

  1. data through intervention or interaction with the individual, or
  2. identifiable private information.
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.

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Systematic Investigation

Methodically testing (quantitatively or qualitatively) a hypothesis or research question by gathering and analyzing data with the intention of drawing conclusions

Examples of systematic investigations are:

  • Surveys
  • Questionnaires
  • Interviews
  • Focus groups
  • Participant observation
  • Existing data analysis
  • Program evaluation
  • Social or psychological experiments
  • Drug trials
Generalizable Knowledge

Data designed to apply to a population beyond the research subjects themselves and contribute to current academic understanding

Generalizable knowledge generally refers to:

  • Published papers
  • Oral presentations
  • Posters at a conference
  • Dissertation or thesis

If a project is only to be conducted for a class project, it is not considered generalizable knowledge. But please keep in mind that if you are planning to use your class project as the basis for further research later on, which meets the definition of "human subjects research," you will need IRB approval for the class project (IRB approval is not retroactive).

About Whom
Refers to information the subject discloses about him/herself (including his/her opinions), as opposed to information/facts the subject shares regarding an external topic (such as a program, product, or procedures) about which the subject can be considered an expert.
Physical procedures by which data are gathered and manipulations of the subject or the subject's environment are performed for research purposes
Communication or interpersonal contact between investigator and subject
The identity of the subject is or may readily be ascertained by the investigator or associated with the information
Private Information
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)