Policies & Guidance
IRB Standard Operating Procedures (SOPs)
Purview and Training
- Determination of Activities that Need IRB Review [C1.0100] (Revised 2/15/19) [PDF]
- IRB Membership [C1.0150] (Revised 2/15/19) [PDF]
- IRB Member & Consultant Conflict of Interest [C1.0200] (Revised 6/21/13) [PDF]
- IRB Members/ORI Staff Training [C1.0250] (Revised 5/9/19) [PDF]
- Generation, Use, & Revisions of SOPs [C1.0300] (Revised 10/22/10) [PDF]
- IRB Reliance [C1.0350] (Revised 2/20/24) [PDF]
Review Mechanisms/Outcomes
- Initial Full Review [C2.0100] (Revised 5/9/19) [PDF]
- Initial Expedited Review [C2.0150] (Revised 2/15/19) [PDF]
- Exempt Review [C2.0200] (Revised 5/21/23) [PDF]
- Continuation and Annual Administrative Review [C2.0250] (Revised 2/15/19) [PDF]
- Modification - IRB Review of Changes [C2.0300] (Revised 5/14/23) [PDF]
- Deviations and Exceptions - IRB Review of Changes [C2.0325] (3/15/19) [PDF]
- Unanticipated/Anticipated Problem/Adverse Event Reporting [C2.0350] (Revised 5/9/19) [PDF]
- Protocol Violation Review [C2.0400] (Revised 5/9/19) [PDF]
- HIPAA in Research [C2.0450] (Revised 7/18/11) [PDF]
- Subject Concerns/Complaints [C2.0500] (Revised 8/19/09) [PDF]
- Noncompliance [C2.0550] (Revised 9/4/14) [PDF]
- Termination or Suspension of Research by the IRB [C2.0600] (Revised 7/8/11) [PDF]
- Conduct of IRB Meetings [C2.0650] (Revised 5/9/19) [PDF]
Special Requirements
- Informed Consent [C3.0050] (Revised 9/10/21) [PDF]
- Protection of Vulnerable Subjects [C3.0100] (Revised 2/15/19) [PDF]
- Medical Device Clinical Investigations, Compassionate Use, and Treatment IDE [C3.0150] (Revised 8/6/20) [PDF]
- Humanitarian Use Device (HUD) [C3.0200] (Revised 5/9/19) [PDF]
- Emergency Use [C3.0250] (Revised 5/9/19) [PDF]
- Expanded Access Program (EAP) for Drugs [C3.0300] (Revised 8/5/20) [PDF]
- Data and Safety Monitoring Plan [C3.0350] (Revised 7/18/12) [PDF]
- NCI CIRB Review [C3.0400] (Revised 3/23/23) [PDF]
Recordkeeping and External Reporting
- Minutes of IRB Meetings [C4.0050] (Revised 5/9/19) [PDF]
- Inspections by Regulatory Agencies [C4.0100] (Revised 5/2/19) [PDF]
- Mandated Reporting to External Agencies [C4.0150] (Revised 5/14/23) [PDF]
- Study Closure [C4.0200] (Revised 5/21/23) [PDF]
- IRB/ORI Recordkeeping [C4.0250] (Revised 5/9/19) [PDF]
Coordination
- Institutional Biosafety Committee (IBC)/IRB Coordination [C6.0100] (Revised 2/15/17) [PDF]
- Investigational Drug Service (IDS)/IRB Coordination [C6.0350] (Revised 5/9/19) [PDF]
- Markey Cancer Center (MCC)/IRB Coordination [C6.0400] (Revised 3/11/21) [PDF]
- Radiation Safety Officer (RSO) Coordination [Use of Radioactive Materials] [C6.0500] (Revised 5/9/19) [PDF]
- Office of Sponsored Projects Administration (OSPA)/IRB Coordination [C6.0600] (Revised 4/30/19) [PDF]
- Investigator Conflict of Interest/OSPA/IRB/ORI Coordination [C6.0650] (Revised 8/30/17) [PDF]
- Radioactive Drug Research Committee (RDRC)/IRB Coordination [C6.0750] (Revised 7/24/06) [PDF]
- Subject Use and Research Ethics Committee/IRB Coordination [C6.0800] Suspended until further notice
- Department of Defense IRB/ORI Coordination [C6.0850] (Revised 8/4/20) [PDF]
- Federal Agency "Specific" Requirements IRB/ORI Coordination [C6.0900] (In Effect 12/14/12) [PDF]
- Center for Clinical and Translational Science IRB/ORI Coordination [C6.0950] (In Effect 4/8/13) [PDF]