Ethical Principles of Human Subjects Protection

• The Belmont Report 
  • Ethical Principles on which the U. S. system of human subjects protection is based.
• The Nuremberg Code  
  Ethics code developed during the military war crimes trial.
• Declaration of Helsinki  
  The World Medical Association's ethical principles for medical research involving human subjects.

Federal Agencies Guidelines and Regulations

• Office of Human Research Protections
  • (45 CFR 46) Code of Federal Regulations for Human Subject Protection  
• Office of Civil Rights
• Food & Drug Administration
  • (21 CFR 50) Protection of Human Subjects
  • (21 CFR 56) Institutional Review Boards 
  • (21 CFR 312) Investigational New Drug Application
    • Drug Application Form 1571and 1572
  • (21 CFR 600) Biological Products
  • (21 CFR 812) Investigational Device Exemptions
  • New Clinical Trial Registration Rule
  • FDA Centers
    • Device Advice
    • Center for Biologics Evaluation and Research (CBER)
    • Center for Drug Evaluation and Research (CDER)
  • Certificate of Confidentiality (COC) -  FDA's Certificates of Confidentiality Application Instructions.
• National Institutes of Health (NIH)
  • ONIH-NCI Tutorial - Human Participant Protections Education for Research Teams
  • Revised Policy for IRB Review of Human Subjects Protocols in Grant Applications

Penn State Web Sites

• PSHMC Office of Research Affairs (Hershey Campus)
• PSHMC Research Development
• PSHMC Office of Technology Development
• PSHMC Clinical Trials Office
• PSHMC BioSafety
• PSHMC Clinical Research Training Programs
• PSHMC Medical Student Research Program
• General Clinical Research Center at PSHMC
• General Clinical Research Center at University Park  (Noll Lab)
• Office for Research Protections (IRB for Main Campus and other branches)

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