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IRB Resources

Forms

  • Conflict of Interest Policy
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  • State of California Requirements Pertaining to the Review of Human Subjects Research
  • State of Maryland Requirements Pertaining to the Review of Human Subjects Research

Regulations

  • 45 CFR 46 (DHHS)
  • 21 CFR 50 (FDA – Protection of Human Subjects)
  • 21 CFR 56 (FDA – Institutional Review Boards)
  • 21 CFR 312 (FDA – Investigational New Drug Application)
  • 21 CFR 812 (FDA – Investigational Device Exemptions)

Useful Links

  • Office of Human Research Protections (OHRP)
  • Food and Drug Administration (FDA)
  • FDA Guidance for IRBs and Clinical Investigators
  • NIH Certificates of Confidentiality
  • Belmont Report
  • Nuremberg Code
  • Declaration of Helsinki

 

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