Original and diligent inquiry, examination, or investigation undertaken in order to understand “the nature of things”; its intent is to expand the scientific knowledge base through systematic observation. Broadly defined, research includes the invention and generation of ideas, images, performances, artifacts (including design) where these lead to new or substantially improved insights, materials, devices, products, and processes. Research excludes routine testing and routine analysis of materials, components, and processes, as well as the development of teaching materials that do not embody original research.
- Basic Research– Theoretical or experimental work undertaken primarily to acquire truth, knowledge, or improve theoretical understanding regarding the nature of things without any particular application or practical use in mind or without an eye toward its commercial value.
- Applied Research – Original investigation undertaken in order to acquire new knowledge that is directed primarily towards a specific practical aim or objective or towards improving the human condition. May have commercial value.
- Clinical Research – NIH has adopted a three-part definition: 1) Patient-oriented investigations during which the investigator interacts directly with subjects to understand the mechanisms, etiology, and pathogenesis of disease; evaluate therapeutic interventions; or develop new technologies, drugs, or devices. 2) Epidemiologic and behavioral studies. 3) Outcomes research and health services research. Excluded from this definition are in vitro studies that utilize human tissues but do not require the investigator to deal directly with patients. At UGA, patient-oriented projects include both humans and animals. Clinical Trials (defined below) are a type of Clinical Research. Research on animals in the Teaching Hospital of the College of Veterinary Medicine is considered Clinical Research unless the protocol meets the strict definition of a Clinical Trial.
- Patient-oriented Research – Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator directly interacts with human subjects. This area of research includes the development of new technologies, mechanisms of human disease, therapeutic interventions, disease control, and clinical trials. Investigators must have direct interaction with human subjects and relate the research results to the patient status or outcome.
- Epidemiologic and Behavioral Studies– The investigation of the prevalence, incidence, and risk factors for disease. Often utilize longitudinal study methodology, retrospective assessments, and/or surveys comparing different populations that have been exposed to different risk factors and/or behavior. These studies help to identify potential risk factors that may have an association with an outcome.
- Outcome and Health Services Research – This research is similar to, but departs from, the previous types of research in that it aims to examine the outcomes resulting from different types of approaches and methodology of health services on patient populations.
- Clinical Trial– A carefully designed and rigorously controlled study or series of studies (usually done in four phases) to provide extensive data that will allow for statistically valid evaluation of the safety and efficacy and therapeutic benefit(s) of drugs, devices, treatments, or other preventive measures and use human volunteers or animals as subjects. The activity is typically carried out in a controlled environment in a clinic or other medical facility, and the protocol used is typically developed by the sponsor.
- Proprietary Testing– Non-investigator initiated research activities driven by a sponsor’s specific protocol, know-how, or intellectual property for which no inventions are expected to result and no publications are expected to be produced as outcomes. Sometimes the term “work for hire” is used interchangeably. A Clinical Trial may be a type of Proprietary Testing activity.