Resources

Research Ethics

To understand the broader context for the development of the federal regulations, and to understand the ethical foundations of the regulations, start by reading:

• The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington: 1979. Available at: http://www.hhs.gov/ohrp/belmontArchive.html

Regulations

• 45 CFR 46 Protection of Human Subjects (See also Guidance concerning these regulations offered by the federal Office of Human Research Protections)
• 21 CFR 50 Protection of Human Subjects
• 21 CFR 56 Institutional Review Boards
• 21 CFR 812 Investigational Device Exemptions (for research involving medical devices, including but not limited to laboratory test kits)
  • (See also Information Sheets from FDA concerning these regulations, available in English and Spanish)