Operational Guidelines for Ethics Committees That Review ...

TABLE OF CONTENTS
PREFACE ...................................................................................... v
1 OBJECTIVE .............................................................................1
2 THE ROLE OF AN EC ..............................................................1
3 ESTABLISHING A SYSTEM OF ETHICAL REVIEW ...............2
4 CONSTITUTING AN EC ..........................................................2
4.1 Membership Requirements............................................... 3
4.2 Terms of Appointment ...................................................... 4
4.3 Conditions of Appointment .............................................. 4
4.4 Offices .............................................................................. 5
4.5 Quorum Requirements ..................................................... 5
4.6 Independent Consultants ................................................. 5
4.7 Education for EC Members ............................................. 6
5 SUBMITTING AN APPLICATION ............................................6
5.1 Application ....................................................................... 6
5.2 Application Requirements ................................................ 6
5.3 Documentation ................................................................. 7
6 REVIEW ..................................................................................9
6.1 Meeting Requirements ..................................................... 9
6.2 Elements of the Review .................................................. 10
6.3 Expedited Review ........................................................... 13
7 DECISION-MAKING .............................................................14
8 COMMUNICATING A DECISION ..........................................15
9 FOLLOW-UP ..........................................................................16
10 DOCUMENTATION AND ARCHIVING .................................18
GLOSSARY .................................................................................21
SUPPORTING DOCUMENTS ......................................................23
COMMITTEES ............................................................................25
BACKGROUND ..........................................................................29
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