Human Subjects

What is the definition of a Human Subject?

A living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual; or (2) identifiable private information. Private identifiable specimens, records, and data about individuals are considered to be human subjects, even if the researcher has no contact or interaction with the individuals.

What is the definition of Research? A systematic investigation (an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question), including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Examples of systematic investigations

• Analysis of existing data or biological specimens
• Surveys and questionnaires and epidemiological studies
• Interviews and focus groups
• Evaluations of social or educational programs
• Medical chart review