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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 HRPP Office

The federal regulations in 45 CFR 46, give the following definitions:

Research

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

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.

Expand All / Collapse All

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
  • Secondary data analysis
  • 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.
Intervention
Both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment are performed for research purposes
Interaction
Communication or interpersonal contact between investigator and subject
Identifiable
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)

Is it Research?

Activities deemed not to be research
  • Validation of study instruments

  • Oral history

  • Journalism

  • Biography

  • Literary criticism

  • Legal research

  • Historical scholarship

  • Literature searches

  • Data collection such as surveys, interviews, or focus groups involving things, products, or policies only - and no opinions

  • Data collection regarding a specific individual that is not meant to be generalizable

  • Quality assurance activities or evaluation projects designed for self- improvement or program evaluation

  • Data collection for internal departmental, university, or administrative purposes

  • Course-related activities designed for educational purposes only

Program Evaluation vs Human Subjects Research

Distinguishing between simple evaluation and human subjects research can sometimes be difficult. While the federal regulations use the term evaluation in their definition of research, most program evaluations do not, in fact, fall under this definition. The chart below lists some features that are common to each type of project and is intended to help investigators determine whether their project requires review by the HRPP and/or IRB.

Note that not all projects will fall squarely into one column or the other; if in doubt, always contact the HRPP for guidance. 

Social and Behavioral Human Subjects Research vs Program Evaluation

Oral History

The Federal Register, in its preamble to the Common Rule, explains its meaning of oral history:

Studies using methods such as participant observation and ethnographic studies in which investigators gather information from individuals in order to understand their beliefs, customs, and practices, and [where] the findings apply to the studied community or group, and not just the individuals from whom the information was obtained, fall within the scope of the definition of research.

More helpful information can be found on the UMass website