Regulatory Resources

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 Human Subject Regulation Decision Charts