NIH Definition of Clinical Trial
The NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information (NOT-OD-16-149) became effective on January 18, 2017. This initiative involves additional requirements for any NIH-supported research that engages human participants. These requirements include:
- dedicated funding opportunity announcements (FOA's)
- Good Clinical Practice training
- registration and results reporting on ClinicalTrials.gov
- single IRBs for multi-site studies
Four Questions for Researchers and Institutions
If the answer to all four of these questions is yes, then the NIH considers your research to be a clinical trial.
- Does the study involve human participants?
- Are the participants prospectively assigned to an intervention?
- Is the study designed to evaluate the effect of the intervention on the participants?
- Is the effect that will be evaluated a health-related biomedical or behavioral outcome?
NIH has provided guidance on answering these questions.