Research Terms/Definitions – H

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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 – A living individual about whom an investigator (whether professional or student) conducting research:

(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens: or

(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.