Definition of Human Subjects Research
Human subjects research is any research or clinical investigation that involves human subjects.
Investigators conducting human subjects research must satisfy DHHS regulations [45 CFR Part 46] and FDA regulations [21 CFR Part 50 and 56] regarding the protection of human subjects research, as applicable. When considering whether an activity meets the definition of human subjects research per DHHS regulations one must consider two federal definitions: research and human subject.
Research is as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
A “systematic investigation” is an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question.
Examples of systematic investigations include:
- surveys and questionnaires
- interviews and focus groups
- analyses of existing data or biological specimens
- epidemiological studies
- evaluations of social or educational programs
- cognitive and perceptual experiments
- medical chart review studies
Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program (e.g., publications or presentations). However, research results do not have to be published or presented to qualify the experiment or data gathering as research. The intent to contribute to “generalizable (scholarly) knowledge” makes an experiment or data collection research, regardless of publication. Research that never is published is still research. Participants in research studies deserve protection whether or not the research is published.
Examples of activities that typically are not generalizable include:
- oral histories that are designed solely to create a record of specific historical events
- service or course evaluations, unless they can be generalized to other individuals
- services, courses, or concepts where it is not the intention to share the results beyond the UCI community
- classroom exercises solely to fulfill course requirements or to train students in the use of particular methods or devices
- quality assurance activities designed to continuously improve the quality or performance of a department or program where it is not the intention to share the results beyond the UCI community.
A human subject is 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.
- Intervention includes both physical procedures by which data are gathered (e.g., venipuncture) 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 (for example, a medical record). 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) in order for obtaining the information to constitute research involving human subjects.