Definition of Human Subjects Research
Definition of Human Subjects Research
In order to ensure the rights, welfare, and protection of all subjects, all human subjects research, and all other activities, which in part involve human subject research, regardless of sponsorship, must be reviewed and approved by the IRB prior to initiation. This includes all interventions and interactions with human subjects for research, including advertising, recruitment and/or screening of potential subjects. Please review the information below to understand what activities meet the definition of human subjects research.
A project must be BOTH research and involve human subjects to require IRB review.
The DHHS definition of human subjects will generally apply to all human research conducted by investigators at the University of Virginia unless the research involves a test article. Those investigations involving a test article will also be subject to FDA regulations. DHHS regulations under 45CFR46.102(f) define a human subject 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.
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.
Interaction includes communication or interpersonal contact between investigator and subject.
FDA regulations define human subject as an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.
DHHS regulations define research 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 UVa 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 UVa community.
Note: Thesis or dissertation projects conducted to meet the requirement of a graduate degree are usually considered generalizable, and require IRB review and approval.
FDA regulations define a clinical investigation as any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the FDA, or is not subject to requirements for prior submission to the FDA under these sections of the Federal Food, Drug, and Cosmetic Act, but the results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an application for a research or marketing permit.
A test article means any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the Federal Food, Drug, and Cosmetic Act.
Examples of clinical investigations include:
- Investigational drug clinical trials
- Medical treatment with investigational device study
- Medical outcomes study comparing approved drugs/devices
For examples of types of projects that meet and do not meet the definition of Human Subject Research see Examples of Activities That Do and Do Not Require IRB–HSR Review