Glossary of Human Subjects and IRB Related Terms
There are currently 5 names in this directory beginning with the letter H.
Health Insurance Portability and Accountability Act (HIPAA)
The rule which protects the privacy of individually identifiable health information. The privacy rule provides federal protections for personal health information held by covered entities and gives patients specific rights with respect to that information.
Human Research
Any activity that either: Is Research as Defined by DHHS and involves Human Subjects as Defined by DHHS; or Is Research as Defined by FDA and involves Human Subjects as Defined by FDA. The terms “Human Subject Research,” “Research Involving Human Subjects,” “Human Subject Research,” “Research Involving Human Subjects,” “Clinical Research,” “Clinical Investigation,” “Clinical Study” and similar phrases are considered to be synonyms for the term Human Research.
Human Subject as Defined by DHHS
Human subject means 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.
Human Subject as Defined by FDA
An individual who is or becomes a subject 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. A human subject includes an individual on whose specimen a medical device is used.