Guidance and Education – Human Research​

Guidance for Investigators

• HHS – Regulations, Policy & Guidance Homepage​
  • Guidance Documents
  • Decision Charts (NHSR, Exemption, Continuing Review, Consent Waivers)
  • Revised Common Rule (2018 updates)​

Educational Programs and Videos

• HHS – Education and Outreach Resources​
• OHRP – Training Resources on Human Research Protection (YouTube Playlist)

Regulatory Links

• HHS – Office for Human Research Protections​
• FDA – Science and Research Homepage​
  • Clinical Trials and Human Subject Protection
• Health Insurance Portability and Accountability Act (HIPAA) – Research
• Department of Education – Family Education Rights and Privacy Act (FERPA)
• eCFR – Code of Federal Regulations
  • 45 CFR 46 (HHS – Common Rule)
  • 21 CFR 50 (FDA – Protection of Human Subjects)
  • 21 CFR 56 (FDA – Institutional Review Boards)
    

Historical Documents

• The Belmont Report​​
• Declaration of Helsinki
• Nuremberg Code
• Research Ethics Timeline (continually updates)