Federal & State Regulations & Guidance Materials

Department of Health and Human Services (DHHS)

OHRP - Office for Human Research Protections

  • 45 CFR 46 - Federal Regulations for the Protection of Human Subjects

OCR - Office for Civil Rights - HIPAA

  • 45 CFR 164 - Health Insurance Portability and Accountability Act (HIPAA) Security and Privacy Regulations

NIH - National Institutes of Health

FDA - Food and Drug Administration

CDER - Center for Drug Evaluation and Research (Investigational New Drugs)

CDRH - Center for Devices and Radiological Health (Investigational Medical Devices)

VHA - Veterans Health Administration 

  • ORO (Office of Research Oversight)

NSF - National Science Foundation 

General