Research Definitions

Research: a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

This includes activities which meet the definition whether or not they are conducted under a program which is considered research for other purposes; for example, demonstration and service programs may include research activities.

Human Subject: a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or identifiable private information.

Clinical Investigation: any experiment that involves a test article and one or more human subjects.

Prospective Research If the research study involves data or specimens that have not been created or collected at the time of IRB submission.

Retrospective Research: If the research study involves data or specimens that already exist in their entirety at the time of IRB submission