As part of the NIH initiative to improve the quality and transparency of NIH supported research, a suite of initiatives have been launched. These initiatives include dedicated funding opportunity announcements for clinical trials, Good Clinical Practice training, enhanced registration and results reporting on ClinicalTrials.gov, and required use of single IRBs for multi-site studies.
Determining whether these initiatives apply to your research largely depends on whether your research meets the NIH definition of a clinical trial. The NIH definition of a clinical trial is “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes”.
The NIH has also boiled down this definition to some basic questions researchers need to ask, and answer. These questions are:
- Is your research funded by NIH?
- 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?
If the answer to all four questions is yes, then NIH considers your research a clinical trial.
Should you have any questions about this NIH policy and requirements, please contact the CUHS IRB office at (617) 496-2847 or email@example.com
Here are some additional resources that you may find helpful:
Frequently asked questions:
Definition of Clinical Trial Case Studies: