NOHSP Definitions - H

A glossary of terms and concepts found in the Nemours HSP policies and procedures. References and resources are located in the policy noted by HSP### after each definition.

H

HIPAA: Health Insurance Portability and Accountability Act. (HSP#029)

Human Subject: “Human Subject” as defined by DHHS regulations means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. [45 CFR 46.102(f)]. (HSP#050) (See ‘Intervention’, ‘Interaction’, ‘Private Information’ and ‘Identifiable Information’)

“Intervention” as defined by DHHS regulations means 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. [45 CFR 46.102(f)]

“Interaction” as defined by DHHS regulations means communication or interpersonal contact between investigator and subject. [45 CFR 46.102(f)]

“Private information” as defined by DHHS regulations means 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). [45 CFR 46.102(f)]

“Identifiable information” as defined by DHHS regulations means information that is individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information).

"Human subject" as defined by FDA regulations means:

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. [21 CFR 50.3(g)
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 subject may be in normal health or may have a medical condition or disease. [21 CFR 812.3(p)

Human Subject Research means any activity that either:

Meets the DHHS definition of “research” and involves “human subjects” as defined by DHHS; or
Meets the FDA definition of “research” and involves “human subjects” as defined by FDA.(HSP#050) (See ‘Research’)

Humanitarian use device (HUD): a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 individuals in the United States per year. (HSP-047)

Humanitarian Device Exemption (HDE): A FDA pre-marketing application for a HUD. A FDA approved HDE authorizes marketing of the HUD. However, an HUD may only be used after IRB approval has been obtained for the use of the device for the FDA approved indication. The labeling for an HUD must state that the device is a humanitarian use device and that, although Federal Law authorizes the use of the device, the effectiveness of the device for the specific indication has not been demonstrated. (HSP-047)