|
1. |
Purview and Training |
|
a) |
Determination of
Activities That Need IRB Review [C1.0100] |
[WORD] |
[PDF] |
Revised 7/8/11 |
|
b) |
IRB Membership [C1.0150] |
[WORD] |
[PDF] |
Revised
10/24/11 |
|
c) |
IRB Member & Consultant Conflict of
Interest [C1.0200] |
[WORD] |
[PDF] |
Revised 11/6/09 |
|
d) |
IRB Members/ORI Staff Training [C1.0250] |
[WORD] |
[PDF] |
Revised 7/8/11 |
|
e) |
Generation, Use, &
Revisions of SOPs [C1.0300] |
[WORD] |
[PDF] |
Revised 10/22/10 |
|
f) |
Off-site Research [C1.0350] |
[WORD] |
[PDF] |
Revised 8/19/09 |
|
|
| 2. |
Review
Mechanisms/Outcomes |
| a) |
Initial Full Review [C2.0100] |
[WORD] |
[PDF] |
Revised 7/8/11 |
| b) |
Initial Expedited
Review [C2.0150] |
[WORD] |
[PDF] |
Revised 7/8/11 |
| c) |
Exempt Review [C2.0200] |
[WORD] |
[PDF] |
Revised 7/8/11 |
| d) |
Continuation
Review [C2.0250] |
[WORD] |
[PDF] |
Revised 7/8/11 |
| e) |
Modification, Deviations
& Exceptions Review [C2.0300] |
[WORD] |
[PDF] |
Revised
4/26/10 |
| f) |
Unanticipated/Anticipated
Problem/ Adverse Event Reporting [C2.0350]
|
[WORD] |
[PDF] |
Revised 7/8/11 |
| g) |
Protocol Violation
Review [C2.0400] |
[WORD] |
[PDF] |
Revised 8/19/09 |
| h) |
HIPAA in Research [C2.0450] |
[WORD] |
[PDF] |
Revised
7/18/11 |
| i) |
Subject
Concerns/Complaints [C2.0500] |
[WORD] |
[PDF] |
Revised
8/19/09 |
| j) |
Noncompliance [C2.0550] |
[WORD] |
[PDF] |
Revised
7/8/11 |
| k) |
Termination and
Suspension of Research by the IRB [C2.0600] |
[WORD] |
[PDF] |
Revised
7/8/11 |
l) |
Conduct of IRB Meetings [C2.0650] |
[WORD] |
[PDF] |
Revised 7/29/11 |
|
|
| 3. |
Special Requirements |
| a) |
Informed Consent [C3.0050] |
[WORD] |
[PDF] |
Revised 7/29/11 |
| b) |
Protection of Vulnerable
Subjects [C3.0100] |
[WORD] |
[PDF] |
Revised 7/29/11 |
| c) |
Medical Devices [C3.0150] |
[WORD] |
[PDF] |
Revised 7/31/09 |
| d) |
Humanitarian Use Device (HUD) [C3.0200] |
[WORD] |
[PDF] |
Revised 7/20/11 |
| e) |
Emergency Use [C3.0250] |
[WORD] |
[PDF] |
Revised 7/20/11 |
| f) |
Expanded Access Program
(EAP) for Drugs [C3.0300] |
[WORD] |
[PDF] |
Effective 7/20/11 |
| g) |
Data and Safety
Monitoring Plan [C3.0350] |
[WORD] |
[PDF] |
Revised 10/12/11 |
| h) |
NCI CIRB Review [C3.0400] |
[WORD] |
[PDF] |
Revised 6/10/11 |
|
|
| 4. |
Recordkeeping and
External Reporting |
| a) |
Minutes of IRB
Meetings [C4.0050] |
[WORD] |
[PDF] |
Revised
7/29/11 |
| b) |
Inspections by
Regulatory Agencies [C4.0100] |
[WORD] |
[PDF] |
Revised
7/29/11 |
| c) |
Mandated Reporting to
External Agencies [C4.0150] |
[WORD] |
[PDF] |
Revised 7/29/11 |
| d) |
Study Closure [C4.0200] |
[WORD] |
[PDF] |
Revised 8/19/09 |
| e) |
IRB/ORI Recordkeeping [C4.0250] |
[WORD] |
[PDF] |
Revised
7/29/11 |
|
|
|
5. |
Quality
Improvement & Assessment |
| a) |
Directed On-Site Review [C5.0050] |
[WORD] |
[PDF] |
Revised 7/29/11 |
| b) |
PI Self-Assessment
Review [C5.0150] |
[WORD] |
[PDF] |
Revised 8/19/09 |
| c) |
Administrative
Assessment Review [C5.0200] |
[WORD] |
[PDF] |
Revised 7/29/11 |
|
|
| 6. |
Coordination |
| a) |
Institutional Biosafety
Committee (IBC)/IRB Coordination [C6.0100] |
[WORD] |
[PDF] |
Revised 6/30/07 |
| b) |
Investigational Drug
Service (IDS)/IRB Coordination [C6.0350] |
[WORD] |
[PDF] |
Revised 8/15/11 |
| c) |
Markey Cancer Center
(MCC)/IRB Coordination [C6.0400] |
[WORD] |
[PDF] |
Revised 12/15/09 |
| d) |
Radiation Safety Officer
(RSO) Coordination [Use of
Radioactive Materials] [C6.0500] |
[WORD] |
[PDF] |
Revised 8/7/09 |
| e) |
Office of Sponsored
Projects Administration (OSPA)/IRB Coordination [C6.0600] |
[WORD] |
[PDF] |
Revised
6/24/11 |
| f) |
Investigator Conflict of Interest/OSPA/IRB Coordination [C6.0650] |
[WORD] |
[PDF] |
Revised
11/6/09 |
| g) |
Radioactive Drug
Research Committee (RDRC)/IRB Coordination [C6.0750] |
[WORD] |
[PDF] |
Revised
7/24/06 |
h) |
Subject
Use and Research Ethics Committee/IRB Coordination [C6.0800] |
[WORD] |
[PDF] |
Revised 11/1/08 |
| i) |
Department of Defense IRB/ORI Coordination [DRAFT] [C6.0850] |
[WORD] |
[PDF] |
Effective 11/10/09 |
|
