Federal Regulations - ARCHIVED

04/23/2021: This page has been archived. IRBMED Guidance pages throughout Research A-Z link to relevant federal websites

• Regulations enforced by the Food and Drug Administration (FDA)
  • 21 CFR 50 -- Protection of Human Subjects
  • 21 CFR 56 -- Institutional Review Boards
  • 21 CFR 11-- Electronic Records; Electronic Signatures
  • 21 CFR 312 -- Investigational New Drug (IND) Application 
    • Decision tree to determine whether an IND is required
    • Bioavailability or Bioequivalence Studies--Decision tree to determine if an IND is required 
    • MICHR IND / IDE Investigator Assistance Program (MIAP)
• 21 CFR 812 -- Investigational Device Exemption (IDE) Application 
  • IDE Guidance 
  • Decision tree to determine if an IDE is needed for Custom or Diagnostic Devices
  • MICHR IND / IDE Investigator Assistance Program (MIAP)
• Exception from Informed Consent for Studies Conducted in Emergency Settings
• Use of Investigational Products When Subjects Enter a Second Institution - Information Sheet
• Regulations enforced by the Office of Human Research Protections (OHRP)
  • 45 CFR 46 -- Protection of Human Subjects
  • OHRP Home
• FDA/OHRP University of Michigan Registration -- This page provides information frequently requested by sponsors regarding the University's compliance with new registration rules.
• The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research

Created 4/17/2012