Human Subjects Research Definition

Human Subjects Research Definition

Note: If any term used in this policy is unclear, please check the glossary page.

1. A human subject is defined as a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information about whom includes a subject’s opinion on a given topic.

Intervention includes both physical procedures by which data are gathered 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. 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 through coding) in order for obtaining the information to constitute research involving human subjects.

2. Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of the federal policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

Shelton (1999) further clarifies human subjects research:

“A key aspect of research is that there be a systematic design in advance, generally utilizing a scientific approach or protocol, for the definite purpose of contributing to generalizable knowledge.  Research can include a wide variety of activities, including experiments, observational studies, surveys, tests, and recordings designed to contribute to generalizable knowledge. It generally does not include such operational activities as medical care, quality assurance, quality improvement, certain aspects of public health practice such as routine outbreak investigations and disease monitoring, program evaluation, fiscal or program audits, journalism, history, biography, philosophy, “fact-finding” inquiries (such as criminal, civil, and congressional investigations, intelligence gathering), and simple data collection for other purposes.  However, some of these activities may include or constitute research in the specific circumstance where there is clear advance intent to contribute to generalizable knowledge with a formal scientific protocol.

Shelton, J.D. 1999. How to interpret the federal policy for the protection of human subjects or “common rule” (part A). IRB: Ethics and Human Research. Vol. 21, No. 6, pp. 6-9.