9.4 Approval Periods ..... 34
9.5 Urgent IRB Actions ..... 34
CONTINUING REVIEW OF RESEARCH ..... 34
10.1 Procedures ..... 35
10.2 Review Timeline ..... 35
10.3 Considerations for Continuing Review ..... 36
Risk Assessment and Monitoring ..... 36
Adequacy of Informed Consent ..... 36
Investigator and Institutional Issues ..... 37
Progress of Research Project ..... 37
Verifications from Outside Sources ..... 38
Frequency of Continuing Review ..... 38
10.4 Lapses in IRB Approval ..... 39
Limits on Research after a Lapse ..... 39
Lapse in IRB Approval vs. Suspension or Termination of Approval ..... 40
10.5 Outcomes of Review ..... 40
10.6 Approval Periods ..... 41
10.7 Expedited Review ..... 41
REPORTING OF CHANGES IN RESEARCH ACTIVITY ..... 42
11.1 Procedures ..... 42
11.2 Minor Modifications ..... 43
11.3 Major Modifications ..... 43
11.4 Change in Principal Investigators ..... 44
11.5 Outcomes of Review ..... 44
11.6 No Change in Approval Periods ..... 44
REPORTING OF UNANTICIPATED PROBLEMS ..... 44
12.1 Clarification of Terms ..... 44
Unanticipated Problems ..... 45
Adverse Events ..... 45
12.2 Types of Unanticipated Problems ..... 46
12.3 Procedures for Reporting and Responding to Reports ..... 46
REPORTING OF NONCOMPLIANCE ..... 47
13.1 Clarification of Terms ..... 48
Noncompliance ..... 48
Serious Noncompliance ..... 48
Continuing Noncompliance ..... 48