Policies & Guidance

Determination of Activities that Need IRB Review [C1.0100]
(Revised 2/15/19) 

IRB Membership [C1.0150]
(Revised 2/15/19) 

IRB Member & Consultant Conflict of Interest [C1.0200]
(Revised 6/21/13) 

IRB Members/ORI Staff Training [C1.0250]
(Revised 5/9/19) 

Generation, Use, & Revisions of SOPs [C1.0300]
(Revised 10/22/10) 

IRB Reliance [C1.0350]
(Revised 2/20/24)

Initial Full Review [C2.0100]
(Revised 5/9/19)

Initial Expedited Review [C2.0150]
(Revised 2/15/19)

Exempt Review [C2.0200]
(Revised 5/21/23)

Continuation and Annual Administrative Review [C2.0250]
(Revised 2/15/19)

Modification - IRB Review of Changes [C2.0300]
(Revised 5/14/23)

Deviations and Exceptions - IRB Review of Changes [C2.0325]
(3/15/19)

Unanticipated/Anticipated Problem/Adverse Event Reporting [C2.0350]
(Revised 2/12/25)

Protocol Violation Review [C2.0400]
(Revised 5/9/19)

HIPAA in Research [C2.0450]
(Revised 7/18/11)

Subject Concerns/Complaints [C2.0500]
(Revised 8/19/09)

Noncompliance [C2.0550]
(Revised 9/4/14)

Termination or Suspension of Research by the IRB [C2.0600]
(Revised 7/8/11)

Conduct of IRB Meetings [C2.0650]
(Revised 5/9/19)

Informed Consent [C3.0050]
(Revised 9/10/21)

Protection of Vulnerable Subjects [C3.0100]
(Revised 2/15/19)

Medical Device Clinical Investigations, Compassionate Use, and Treatment IDE [C3.0150]
(Revised 8/6/20)

Humanitarian Use Device (HUD) [C3.0200]
(Revised 5/9/19)

Emergency Use [C3.0250]
(Revised 5/9/19)

Expanded Access Program (EAP) for Drugs [C3.0300]
(Revised 8/5/20)

Data and Safety Monitoring Plan [C3.0350]
(Revised 7/18/12)

NCI CIRB Review [C3.0400]
(Revised 3/23/23)

Minutes of IRB Meetings [C4.0050]
(Revised 5/9/19)

Inspections by Regulatory Agencies [C4.0100]
(Revised 5/2/19)

Mandated Reporting to External Agencies [C4.0150]
(Revised 5/14/23)

Study Closure [C4.0200]
(Revised 5/21/23)

IRB/ORI Recordkeeping [C4.0250]
(Revised 5/9/19)

Directed On-Site Review [C5.0050]
(Revised 5/28/24)

PI Self-Assessment Review [C5.0150]
(Revised 8/9/19)

Administrative Assessment Review [C5.0200]
(Revised 8/9/19)

Institutional Biosafety Committee (IBC)/IRB Coordination [C6.0100]
(Revised 2/15/17)

Investigational Drug Service (IDS)/IRB Coordination [C6.0350]
(Revised 5/9/19)

Markey Cancer Center (MCC)/IRB Coordination [C6.0400]
(Revised 3/11/21)

Radiation Safety Officer (RSO) Coordination [Use of Radioactive Materials] [C6.0500]
(Revised 5/9/19)

Office of Sponsored Projects Administration (OSPA)/IRB Coordination [C6.0600]
(Revised 4/30/19)

Investigator Conflict of Interest/OSPA/IRB/ORI Coordination [C6.0650]
(Revised 8/30/17)

Radioactive Drug Research Committee (RDRC)/IRB Coordination [C6.0750]
(Revised 7/24/06)

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)

Federal Agency "Specific" Requirements IRB/ORI Coordination [C6.0900]
(In Effect 12/14/12)

Center for Clinical and Translational Science IRB/ORI Coordination [C6.0950]
(In Effect 4/8/13)