Is it a clinical trial?

August 18, 2017
NIH has embarked on a number of initiatives that aim to improve the quality and transparency of NIH-funded research involving human participants, e.g., clinical trials. To know if your human subjects research will be affected by new policies resulting from these initiatives, researchers should ask and answer these four questions:
  1. Does the study involve human participants?
  2. Are the participants prospectively assigned to an intervention?
  3. Is the study designed to evaluate the effect of the intervention on the participants?
  4. Is the effect that will be evaluated a health-related biomedical or behavioral outcome?
If the answer to all four is yes, then NIH will consider that research a clinical trial. Read more