• By whom? (Institution, IRB)
• Investigator non-compliance
  • letter from IRB on alleged violation
  • 5 days to respond
  • IRB executive committee reviews
    • resolved
    • further questions
    • protocol suspensions
  • Terminations go to full Board
  • Notify OHRP and FDA
    • serious or continuing non-compliance
    • loss of DHHS funding
• Jeopardize All Research

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