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The role and authority of the FDA is often confused with that of the DHHS (Department of Health and Human Services) and its many branches, especially NIH (National Institutes of Health) and OHRP (Office of Human Research Protections). NIH is primarily a funding agency, not a regulatory agency. OHRP is a regulatory agency governing clinical research that is federally funded.

Many researchers incorrectly assume that because their research is funded by NIH or is conducted in an academic center, that FDA regulations do not apply. However, the FDA has responsibility for clinical investigations of FDA-regulated products:

  • Irrespective of study funding
  • Irrespective of study location within the U.S. (e.g. whether academic or other)
  • Irrespective of whether for commercialization/marketing or for scientific knowledge

Move your mouse over the regions below to distinguish which types of studies are regulated by FDA, OHRP, or Both.