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Glossary

Many of the terms defined on this page may have IRB-specific definition. Students are encouraged to seek out official definitions from their specific IRB.

See also

UGA students should see the UGA Human Research Protection Program Policies and Procedures page, which contains official UGA policies that are routinely evaluated against federal, state and institutional regulations, ethical and accreditation standards, and best practices on human subjects protection.

exempt research
exempt study

Research studies that are exempt from meeting the requirements of the federal regulations for human subjects protections. Research qualifies may be considered exempt if it holds out no more than minimal risk to participants and it falls within one or more of the exemption categories listed by the U.S. Department of Health and Human Services (DHHS) or UGA’s flexibility criteria (FLEX). These categories, with certain conditions and examples, are listed in Appendix A of the UGA Exempt Research policies document.

human subject

A human being as a research subject. For IRB-purposes, the definitions from the U.S. Department of Health and Human Services (DHHS) and the U.S. Food and Drug Administration (FDA) usually apply.

DHHS

A living individual about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual or (2) identifiable private information.

FDA

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 individual or a patient. In addition, a human subject includes an individual on whose specimen an investigational device or control is used, even if the specimen is anonymous

human subjects research

Any research activity that involves human subjects as defined by either the DHHS or the FDA.

PI
principal investigator

The individual primarily responsible for overseeing the preparation, conduct, and administration of human subjects research.

Warning

UGA students, with the exception of post-graduate professional trainees, may not serve as PI and should seek an eligible individual to serve this role on an IRB submission. For CSCI 4800 and CSCI 6800, the PI will typically be your instructor.

researcher

A principal investigator or an individual authorized by the principal investigator and approved by the IRB as a member of the study team, such as a co-investigator, research assistant, or study coordinator.

study coordinator

An individual who works under the guidance of the PI to manage daily activities of clinical research.

key personnel
study team member

An individual who:

  1. interacts with human subjects (e.g., informed consent process, manipulating subject’s environment for research purposes, conduct invasive or non-invasive research procedures),

  2. are involved with collecting, reporting or analyzing identifiable subject data,

  3. function outside of regular work practice (e.g., student administering research testing), or

  4. are faculty advisors providing direct oversight of research involving human subjects, or human subjects’ private information.