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.
Guidance Documents and Frequently Asked Questions (FAQ)
For Parents and Participants
- Clinical Trials Registry (clinicaltrials.gov) – a search engine for registered Clinical Trials that provides information about the study’s purpose, participation, location, and contact information.
- Understanding Medical Research – project patientInform
- NIH Website:
- FDA Website: