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: 
• ​21 CFR 50​ – Protection of Human Subjects and Informed Consent 
• 21 CFR 56 – IRBs
• 21 CFR 312 – Investigational new drugs (IND) and biologics 
• 21 CFR 812​ – Investigational new devices (IDE)

​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 

• ICH Guidelines – These are the international standards for the conduct of clinical trials.
• International Ethical Guidelines for Biomedical Research Involving Human Subjects ​– This statement describes ethical principles for international research.

Guidance Documents and Frequently Asked Questions (FAQ)

• Engagement of Institutions in Human Subjects Research OHRP Guidance
• OHRP and FDA​ Informed Consent Guidance
• Clinical Trials Guidance
• OHRP FAQs:
• Research with Children
• Research with Vulnerable Populations
• Investigator Responsibilities​

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:
• Participating in Clinical Trials 
• Children and Clinical Studies​
• FDA Website:
• Patient Engagement Network 
• Drug and Device Development
• Clinical Trials: What Patients Need to Know
• Questions to Ask​ Before Joining a Research Study

Additional Resources

• Association for Accreditation of Human Research Protections Programs (AAHRPP): The accreditation body that ensures human research protection programs meet rigorous standards for quality and protection.
• Learn more about research with the NIH YouTube catalog
• Office of Research Integrity (ORI)​ website