Single Patient Emergency Use

Guidance

• Ethical Principles
  • The Belmont Report

• Access to Unapproved Drugs, Biologics, & Devices
• Expanded Access
• Single Patient Emergency and Compassionate Use
• Humanitarian Use Devices (HUDs)
• UW IRB Approved Clinical Use HUDs
• Ancillary Review
  • Genomic Data Sharing
• Consent
  • Consent Tip Sheets
  • Consent Examples
  • Consent Templates
  • Electronic Consent Signatures
• Delayed Onset Human Research (DOHR)
• Exempt Research
• International Research
• Just in Time and IRB Review
• Protected and Vulnerable Populations
  • Children
  • Pregnant Women and Neonates
  • Prisoners
• Recruitment
  • Cold Contact Recruitment
• Research Inquiries
• Return of Individual Results
• Specific Federal Agency Requirements
  • Department of Defense
  • Department of Energy
  • Department of Justice
  • Environmental Protection Agency
• Subject Payment