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            "text": "9.4 Approval Periods ..... 34\n9.5 Urgent IRB Actions ..... 34\nX. CONTINUING REVIEW OF RESEARCH ..... 34\n10.1 Procedures ..... 35\n10.2 Review Timeline ..... 35\n10.3 Considerations for Continuing Review ..... 36\nRisk Assessment and Monitoring ..... 36\nAdequacy of Informed Consent ..... 36\nInvestigator and Institutional Issues ..... 37\nProgress of Research Project ..... 37\nVerifications from Outside Sources ..... 38\nFrequency of Continuing Review ..... 38\n10.4 Lapses in IRB Approval ..... 39\nLimits on Research after a Lapse ..... 39\nLapse in IRB Approval vs. Suspension or Termination of Approval ..... 40\n10.5 Outcomes of Review ..... 40\n10.6 Approval Periods ..... 41\n10.7 Expedited Review ..... 41\nXI. REPORTING OF CHANGES IN RESEARCH ACTIVITY ..... 42\n11.1 Procedures ..... 42\n11.2 Minor Modifications ..... 43\n11.3 Major Modifications ..... 43\n11.4 Change in Principal Investigators ..... 44\n11.5 Outcomes of Review ..... 44\n11.6 No Change in Approval Periods ..... 44\nXII. REPORTING OF UNANTICIPATED PROBLEMS ..... 44\n12.1 Clarification of Terms ..... 44\nUnanticipated Problems ..... 45\nAdverse Events ..... 45\n12.2 Types of Unanticipated Problems ..... 46\n12.3 Procedures for Reporting and Responding to Reports ..... 46\nXIII. REPORTING OF NONCOMPLIANCE ..... 47\n13.1 Clarification of Terms ..... 48\nNoncompliance ..... 48\nSerious Noncompliance ..... 48\nContinuing Noncompliance ..... 48",
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