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 (revised definition):

Translational research includes:

1. 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
2. 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
3. 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