Regulatory

Institutional Review Board

Regulatory Resources

Regulations:

FDA:

21 CFR 50 Protection of Human Subjects

21 CFR 56 Institutional Review Boards

21 CFR 312 Investigational New Drug Applications

21 CFR 812 Investigational Device Exemptions

OHRP:

45 CFR 56 Protection of Human Subjects

HIPAA:

45 CFR 164 Security and Privacy

Guidance Documents: 

FDA Clinical Trials Guidance

FDA Guidance for IRBs – Investigators and Sponsors

FDA Medical Devices Guidance

OHRP Guidance Documents

OHRP IRB Guidebook 

OHRP Human Subject Regulation Decision Charts  

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