IRB Resources & Regulations

The Lurie Children’s Institutional Review Board (IRB) has collected the following links as a resource for investigators and participants. 

U.S. Federal Regulations

  • Office of Human Research Protections (OHRP): 
    • 45 CFR 46​ – Regulations that govern all federally funded human research 
    • 45 CFR 164​ – The HIPAA Privacy Rule as applicable for research
  • Food & Drug Administration (FDA) regulations: 

​Ethical Principles and Statements

  • The Belmont Report – This document describes the fundamental ethical principles - respect for persons, justice, and beneficence – of which form the foundation for the U.S. Federal Regulations
  • The Declaration of Helsinki​– This international consensus statement describes additional ethical principles to guide research with human participants. 

International Guidelines 

Guidance Documents and Frequently Asked Questions (FAQ)

For Parents and Participants

Additional Resources