Policies & Procedures - Emory IRB - Emory University

Emory University IRB P&Ps Revised 1/18/2013
23 ORIENTATION & EDUCATION FOR CHAIR AND IRB MEMBERS 82
24 IRB MEMBER LIABILITY, INSURANCE AND INDEMNIFICATION 84
25 CONSULTANTS AND AD HOC REVIEWERS 85
26 CONFIDENTIALITY OBLIGATIONS FOR IRB OFFICIALS, MEMBERS, CONSULTANTS,
STAFF & GUESTS 87
27 DOCUMENTATION AND RECORD RETENTION 89
28 IRB PROTOCOL TRIAGE AND ASSIGNMENT OF REVIEW CATEGORY 93
29 DETERMINATIONS OF HUMAN SUBJECTS RESEARCH OR CLINICAL INVESTIGATION 95
30 EXEMPT RESEARCH 98
31 EXPEDITED REVIEW 104
32 FULL COMMITTEE REVIEW 109
33 IRB MEETINGS 111
34 MINUTES OF AN IRB MEETING 116
35 CONFLICTS OF INTEREST – INVESTIGATORS 119
36 CONFLICTS OF INTEREST ON THE PART OF IRB MEMBERS AND IRB STAFF 122
37 INDEPENDENCE OF EMORY IRB WITH RESPECT TO INSTITUTIONAL AND
INVESTIGATOR INFLUENCE 124
38 POSSIBLE IRB ACTIONS ON HUMAN SUBJECTS RESEARCH PROTOCOLS 126
39 CONTINUING REVIEW 134
40 PROTOCOL MODIFICATIONS (AMENDMENTS) 138
41 CLOSURE OF PROTOCOLS 142
42 CRITERIA FOR EMORY IRB APPROVAL OF RESEARCH 143
43 INFORMED CONSENT 146
44 LEGALLY AUTHORIZED REPRESENTATIVES AND SURROGATE CONSENT 154
45 WAIVER OF DOCUMENTATION OF INFORMED CONSENT 157
46 WAIVER OR ALTERATION OF INFORMED CONSENT FOR RESEARCH 159
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