According to the Federal Regulations: Research with Human Subjects

Discover which studies meet the definition of research with human subjects according to federal regulations. Learn about key points, examples, case studies, and statistics.


Research involving human subjects is a vital component of scientific advancement, but it also raises ethical and legal considerations. According to federal regulations, certain studies meet the definition of research with human subjects. Let’s explore which studies fall under this category.

Key Points

  • Study involving interventions
  • Obtaining identifiable private information
  • Interaction or intervention with individuals


A clinical trial testing a new drug on human participants would clearly fall under the definition of research with human subjects. The study involves interventions on individuals and the collection of private information.

Case Studies

One notable case is the Tuskegee Syphilis Study, where researchers withheld treatment from African American men with syphilis to observe the progression of the disease. This study flagrantly violated ethical principles and led to significant changes in research ethics regulations.


According to the Office for Human Research Protections, in 2020, there were over 290,000 registered studies involving human subjects in the United States. This highlights the widespread use of human subjects in research.

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