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Definitions of Clinical and Translational Research

ITHS › Investigators › Definitions › Definitions of Clinical and Translational Research

Definitions of Clinical and Translational Research

Clinical Research

NIH defines human clinical research as research with human subjects that is: (1) 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 (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies. (2) Epidemiologic and behavioral studies. (3) Outcomes research and health services research. Note: Studies falling under Exemption 4 for human subjects research are not considered clinical research by this definition.

Source: NIH PHS 398 Instructions on Human Subjects Research

Translational Research

Translation: The process of turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and the public.

Translational Science: The field of investigation focused on understanding the scientific and operational principles underlying each step of the translational process.

Source: Definitions provided by the National Center for Advancing Translational Sciences

Translational research includes:

  • the process of making discoveries in the research laboratory or in preclinical studies that will have an impact on human health and may lead to the development of studies in humans,
  • the process of applying discoveries generated during research in the laboratory, and in preclinical studies, to the development of trials and studies in humans and
  • research aimed at enhancing the adoption of best practices in the community. Cost-effectiveness of prevention and treatment strategies is also an important part of translational science.

Source: Based on Institutional Clinical and Translational Science Award (U54) RFA-RM-07-007 CTSA RFA

Using this definition in our review and funding programs, the translational potential of research is rated as:

  • High: Research that will be an important step towards the eventual goal of impacting human health, and the pathway to this impact is clear
  • Moderate: Research that will be a moderately important step towards the eventual goal of impacting human health, and/or the pathway to this impact is only partially defined
  • Low: Research that will have little effect on the eventual goal of impacting human health or research for which the pathway to potential impact is unclear