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Glossary

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Halt

is a cessation of some or all research activities voluntarily initiated by the Principal Investigator or sponsor.

Handicapped

any person who has a physical or mental impairment that substantially limits one or more major life activities.

Health Information

information, whether oral or recorded in any form or medium, that (1) is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and (2) relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual.

Health Science Center

abbreviation for The University of Texas Health Science Center at San Antonio or º£½ÇÂ×ÂÒ

Health Surveillance

an ongoing part of the medical care and public health care functions closely integrated with timely dissemination of these data to those responsible for preventing and controlling disease or injury.

See also:

HHS

abbreviation for Health and Human Services (HHS) or the Department of Health and Human Services (DHHS)

Housing Room

Any location were vertebrate animals are maintained for more than 12 hours or overnight. The Guide defines minimum specifications including acceptable temperature and humidity ranges, appropriate light cycles, required security, sanitizable room surfaces, and HVAC requirements.

HUD Clinical Investigation

a clinical investigation (i.e., research study) using a humanitarian use device (HUD).

See also:

Human Subject

a living individual about whom an investigator conducting research: 1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; OR 2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Human Subjects Research

research involving living individuals whenever the investigator obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens or interacts/intervenes for research purposes.

See also:

Humane Endpoints

criteria used to end experimental studies before all Experimental Endpoints have been met in order to avoid or terminate unrelieved pain and/or distress in animals. An important feature of humane endpoints is that they should be set with the goal of meeting the key study objectives even though the study is ended at an earlier point. Ideally, humane endpoints are sought that can be used to end studies before the onset of pain and distress. Humane endpoints are used to determine when animals can be removed from the study, treated, or euthanized.

Humanitarian Device Exemption

an application to the FDA to market a Humanitarian Use Device (HUD), based on safety and probable benefit.

Humanitarian Use Device

a Medical Device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects no more than 8,000 in the United States per year.

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