Human Subjects (IRB)
All research that involves human subjects (participants) (i.e. survey, experimental, evaluation, biomedical research, use of human subject data) must be approved by the Institutional Review Board (IRB), according to the University's Assurance of Compliance Agreement with the Department of Health and Human Services.
The Institutional Review Board is charged with the responsibility of maintaining institutional compliance with the U.S. Office of Human Research Protections (OHRP) regulations regarding the use of human subjects in research.
A human subject (participant) is defined by the Code of Federal Regulations (CFR) as "a living individual about whom an investigator obtains (1) data through intervention or interaction with the individual or (2) identifiable private information."
Research is defined in the Code of Federal Regulations (CFR) as "a systematic investigation designed to develop and contribute to generalizable knowledge."
Examples of activities that constitute research include:
- any study intended to result in publication or public presentation;
- any activity resulting in publication or public presentation, even though it involves only review of existing data that was collected with no intent to publish; or
- any use of an investigational drug or device.
Thus, human subjects research includes but is not limited to survey and interview research, experimental studies, observational research, as well as evaluation studies if results are made publicly available through presentation or publication.
IRB Lifecycle
Step 1
Step 2
Step 3
Step 5
Some of the links on this page may require additional software to view.