The "Basics" of Human Subjects Research

Research in humans differs from other research in that the subject has decision-making power and must be treated with respect. The long history, even in the name of science of one group of humans exploiting another has made it necessary to establish elaborate rules and procedures to protect human participants in research. The IRB's authority is founded in and guided by many sources. Seminal documents are provided as a resource to the Mayo Clinic Investigator and members of the research team.

• The Belmont Report - Provided by the Office for Human Research Protections
• The Declaration of Helsinki - Provided by the U.S. Food and Drug Administration
• International Conference on Harmonization
• The Nuremberg Code - Provided by the Office for Human Research Protections
• 45 CFR 46 "The Common Rule" - Provided by the Office for Human Research Protections
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  Federal Agencies That Have Adopted "The Common Rule":

  • Central Intelligence Agency
  • Department of Veterans Affairs
  • Environmental Protection Agency
  • Food and Drug Administration
  • NASA
  • National Science Foundation
  • NIH Office of Human Service Research
  • U.S. Agency for International Development
  • U.S. Consumer Product Safety Commission
  • U.S. Department of Agriculture
  • U.S. Department of Commerce
  • U.S. Department of Defense
  • U.S. Department of Education Human Subjects Office
  • U.S. Department of Energy
  • U.S. Department of Homeland Security
  • U.S Department of Housing and Urban Development
  • U.S. Department of Justice
  • U.S. Department of Transportation