Federal and State Regulations & Guidance Materials for Human Subjects Research

OHRP – Office for Human Research Protections

  • 45 CFR 46 – Federal Regulations for the Protection of Human Subject – applies to ALL human subjects studies

NIH – National Institutes of Health

NSF – National Science Foundation

FDA – Food and Drug Administration

Studies using investigational drugs, devices or biologics

VHA – Veterans Health Administration

  • ORO – Office of Research Oversight

HIPPA Regulations

DoD – Department of Defense

General