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
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:
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Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies or analyzes the information or biospecimens.
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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.
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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 include:
Data designed to apply to a population beyond the research subjects themselves and contribute to current academic understanding.
Generalizable knowledge generally refers to:
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Dissertation or thesis
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Oral presentations
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Posters at a conference
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Published papers
If a project is only to be conducted for a class project, it is not considered generalizable knowledge. However, if the data collected for the class project will be used later as the basis for further research that meets the definition of "human subjects research," you will need approval of the Institutional Review Board for that class project (IRB approval is not retroactive).
Refers to information subjects disclose about themselves (including their opinions), as opposed to information/facts the subjects share regarding an external topic (such as a program, product or procedures) about which the subjects can be considered experts.
Both 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.
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.
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 that 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?
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Biography
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Course-related activities designed for educational purposes only
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Data collection for internal departmental, university or administrative purposes
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Data collection regarding a specific individual that is not meant to be generalizable
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Data collection such as surveys, interviews or focus groups involving things, products or policies only — and no opinions
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Historical scholarship
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Journalism
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Literary criticism
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Legal research
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Literature searches
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Oral history
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Quality assurance activities or evaluation projects designed for self-improvement or program evaluation
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Validation of study instruments
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
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.
Learn more about Oral History