Federal & State Regulations

Federal Regulations

• 45 CFR 46: DHHS Protection of Human Subjects 
• 21 CFR 50: FDA Protection of Human Subjects 
• 21 CFR 56: FDA Regulation of IRBs 
• 21 CFR 312: FDA Investigational New Drug Application 
• 21 CFR 812: FDA Investigational Device Exemptions 
• 45 CFR 160 & 164: HIPPA Privacy Rule 
• 45 CFR 160, 162, & 164: HIPPA Security Rule 
• 21 CFR 11: FDA Electronic Records, Electronic Signatures 
• FDA Regulations Relating to Good Clinical Practice and Clinical Trials 

In compliance with Federal financial conflict of interest (fCOI) regulations promulgated by the U.S. Public Health Service (PHS) in 42 CFR Part 50, Subpart F and 45 CFR Part 94, St. Vincent has implemented the Policy entitled, "Financial Conflict of Interest for PHS Funded Research".  That Policy is available here.

State Regulations

• Indiana Administrative Code 844 Medical Licensing Board 
• Indiana Code Title 16 Health 

Links

• Office of Research Integrity 
• Centers for Medicare & Medicaid Services