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Office of Research and Sponsored Programs

Does your human subjects research study meet the NIH definition of a 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

4 Questions for Researchers and Institutions

If the answer to all four questions is yes, the NIH considers your research a clinical trial.

  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?

NIH  has provided guidance on answering these questions.

Additional guidance and help

Completing Forms E - Human Subjects & Clinical Trials Information page

NIH Clinical Trial Requirements for Grants and Contracts

Frequently Asked Questions (NIH)

Background Information - NIH Extramural Nexus - Open Mike