Research Terms/Definitions – H
HRPP: Human Research Protection Program – The systematic and comprehensive approach by an organization to ensure human subject protection in all research. The implementation of any part of the program may be delegated to specific committees, individuals or entities (i.e., academic affiliate or another VAMC) by the organization.
HUD: Humanitarian Use Device – A HUD is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.
Human Subject: Living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information [Federal Policy 46 CFR §46.102(f)]. Under FDA regulations a human subject is defined as [FDA regulations 21 CFR §50.3(g), 21 CFR §56.102(e), 21 CFR §812.3(p):
- An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A participant may be either a healthy human or a patient.
- Or in the case of a medical device: A human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A participant may be in normal health or may have a medical condition or disease.
Intervention includes both physical procedures by which data are gathered (for example, 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.