Effective July 26, 2019, Part I of the OSP Frevvo form (Proposal Data Sheet) will include the following statement in Section 9 – Additional Information:
“This proposal involves Clinical Research and/or Translational Research”
If the proposed project meets the definitions of clinical research and/or translational research the Principal Investigator will select the check box next to this statement.
OSP is collecting this information in order to be able to report on clinical and translational research efforts at Boise State University.
DEFINITIONS:
CLINICAL RESEARCH
Human clinical research is 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: 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.