Guidance and Education – Human Research​

Guidance Documents

Coming soon

Education for Investigators

Coming soon

External and Regulatory Links

• FDA – Science and Research Homepage​
  • Clinical Trials and Human Subject Protection
• HHS – About Research Participation
• HHS – Regulations, Policy & Guidance Homepage​
  • Guidance Documents
  • Decision Charts (NHSR, Exemption, Continuing Review, Consent Waivers)
  • Revised Common Rule (2018 updates)​
• HHS – Health Insurance Portability and Accountability Act (HIPAA)
• Department of Education – Family Education Rights and Privacy Act (FERPA)
  
• 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Historical Documents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)

Additional regulatory and guidance documents can be found in the resources folder within Mentor IRB.