Policies and Guidance

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• Human Research Protection
• Institutional Review Board

  • Submit a New Application
  • Forms and Templates
  • Policies and Guidance
  • Training and Education
  • Case Report/Series
• Clinical Trials Office

UMC IRB Policies & Procedures

• UMC IRB Policies & Procedures Manual – revised 02/2021

Assurance

University Medical Center of Southern Nevada Federalwide Assurance (FWA) number is 00002738. UMCSN’s FWA has been approved by the Office for Human Rights Protection (OHRP).

Federal Offices of Research Regulation

• Office for Human Research Protections (OHRP)
• 45 CFR 46 (DHHS: Protection of Human Subjects)
• US Food and Drug Administration (FDA)
• FDA Clinical Trials and Human Subject Protection
• 21 CFR 50 (FDA: Protection of Human Subjects)
• 21 CFR 56 (FDA: Institutional Review Boards)

Federal Guidance

• HHS
• OHRP
  • Expedited Review Categories
  • Guidance on Expedited Review Procedures
  • Guidance on Continuing Review
  • Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events
  • Guidance on Research Involving Coded Private Information or Biological Specimens
• OCR
  • Health Insurance Portability and Accountability Act (HIPAA)
  • Guidance Regarding Methods for De-identification of Protected Health Information in Accordance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule
• FDA
  • FDA Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors

Ethical Codes/International Guidelines

• Belmont Report
• Nuremberg Code
• Declaration of Helsinki

Other Helpful Links

• NCI CIRB
• Nevada Aids Project
• Nevada Cancer Research Foundation
• Nevada Aids Research and Education Society

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