Standard Operating Procedures (SOPs)
and Policies

To jump to an SOP-Policies section, click on your choice below:

1. Purview and Training

2. Review Mechanisms/Outcomes

3. Special Requirements

4. Recordkeeping and External Reporting

5. Quality Improvement & Assessment

6. Coordination

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1. Purview and Training a) Determination of Activities That Need IRB Review [WORD] [PDF] Revised 11/6/09 b) IRB Membership [WORD] [PDF] Revised 8/21/09 c) IRB Member & Consultant Conflict of Interest [WORD] [PDF] Revised 11/6/09 d) IRB Members/ORI Staff Training [WORD] [PDF] Revised 5/29/09 e) Generation, Use, & Revisions of SOPs [WORD] [PDF] Revised 5/29/09 f) Off-site Research [WORD] [PDF] Revised 8/19/09   Back to Top 2. Review Mechanisms/Outcomes a) Initial Full Review [WORD] [PDF] Revised 11/6/09 b) Initial Expedited Review [WORD] [PDF] Revised 8/21/09 c) Exempt Review [WORD] [PDF] Revised 12/20/07 d) Continuation Review [WORD] [PDF] Revised 8/19/09 e) Modification, Deviations & Exceptions Review [WORD] [PDF] Revised 8/21/09 f) Unanticipated/Anticipated Problem/Adverse Event Reporting  [WORD] [PDF] Revised 8/19/09 g) Protocol Violation Review [WORD] [PDF] Revised 8/19/09 h) HIPAA in Research [WORD] [PDF] Revised 1/5/07 i) Subject Concerns/Complaints [WORD] [PDF] Revised 8/19/09 j) Noncompliance [WORD] [PDF] Revised 11/6/09 k) Termination and Suspension of Research by the IRB [WORD] [PDF] Revised 8/21/09 l) Conduct of IRB Meetings [WORD] [PDF] Revised 1/5/07   Back to Top 3. Special Requirements a) Informed Consent [WORD] [PDF] Revised 11/6/09 b) Protection of Vulnerable Subjects [WORD] [PDF] Revised 11/6/09 c) Medical Devices [WORD] [PDF] Revised 7/31/09 d) Humanitarian Use Device (HUD) [WORD] [PDF] Revised 7/31/09 e) Emergency Use [WORD] [PDF] Revised 7/31/09 f) Treatment IND [WORD] [PDF] Revised 7/24/06 g) Data and Safety Monitoring Plan [WORD] [PDF] Revised 10/12/07 h) NCI CIRB Review [WORD] [PDF] Revised 10/15/07   Back to Top 4. Recordkeeping and External Reporting a) Minutes of IRB Meetings [WORD] [PDF] Revised 8/19/09 b) Inspections by Regulatory Agencies [WORD] [PDF] Revised 1/5/07 c) Mandated Reporting to External Agencies [WORD] [PDF] Revised 8/19/09 d) Study Closure [WORD] [PDF] Revised 8/19/09 e) IRB/ORI Recordkeeping [WORD] [PDF] Revised 11/6/09   Back to Top 5. Quality Improvement & Assessment a) Directed On-Site Review [WORD] [PDF] Revised 8/19/09 b) PI Self-Assessment Review [WORD] [PDF] Revised 8/19/09 c) Administrative Assessment Review [WORD] [PDF] Revised 8/19/09   Back to Top 6. Coordination a) Institutional Biosafety Committee (IBC)/IRB Coordination [WORD] [PDF] Revised 6/30/07 b) Veteran Affairs Medical Center (VAMC)/IRB/ORI Coordination [WORD] [PDF] Revised 8/30/09 c) Investigational Drug Service (IDS)/IRB Coordination [WORD] [PDF] Revised 8/7/09 d) Markey Cancer Center (MCC)/IRB Coordination [WORD] [PDF] Revised 1/5/07 e) Radiation Safety Officer (RSO) Coordination [Use of Radioactive Materials] [WORD] [PDF] Revised 8/7/09 f) Office of Sponsored Projects Administration (OSPA)/IRB Coordination [WORD] [PDF] Revised 1/5/07 g) Investigator Conflict of Interest/OSPA/IRB Coordination [WORD] [PDF] Revised 11/6/09 h) Radioactive Drug Research Committee (RDRC)/IRB Coordination [WORD] [PDF] Revised 7/24/06 i) Subject Use and Research Ethics Committee/IRB Coordination [WORD] [PDF] Revised 11/1/08 J) Department of Defense IRB/ORI Coordination [WORD] [PDF] Effective 11/10/09 Back to Top