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Regulatory Issues

• Repository regulations
  
  
  • Are there regulations for research repositories?
  • How does the Privacy Rule apply to repositories?
    
    
• Human subject research regulations
  
  
  • International codes
  • Federal regulations for human subject research
  • Federal commissions for human subject research
  • Federal guidance for HHS-supported repositories
  • State laws for human subject research
  • Who must comply with federal research regulations?
  • Are there degrees of identifiability?
  • Is there federal guidance on research using repository tissue?