Policies & Guidance

IRB Standard Operating Procedures (SOPs)

Purview and Training

  • Determination of Activities that Need IRB Review [C1.0100] (Revised 1/24/14) [PDF]
  • IRB Membership [C1.0150] (Revised 5/16/14) [PDF]
  • IRB Member & Consultant Conflict of Interest [C1.0200] (Revised 11/6/09) [PDF]
  • IRB Members/ORI Staff Training [C1.0250] (Revised 7/8/11) [PDF]
  • Generation, Use, & Revisions of SOPs [C1.0300] (Revised 10/22/10) [PDF]
  • Off-Site Research [C1.0350] (Under Revision)

Review Mechanisms/Outcomes

  • Initial Full Review [C2.0100] (Revised 3/27/17) [PDF]
  • Initial Expedited Review [C2.0150] (Revised 3/13/15) [PDF]
  • Exempt Review [C2.0200] (Revised 7/8/16) [PDF]
  • Continuation Review [C2.0250] (Revised 2/18/12) [PDF]
  • Modification, Deviations & Exceptions - IRB Review of Changes [C2.0300] (Revised 12/15/17) [PDF]
  • Unanticipated/Anticipated Problem/Adverse Event Reporting [C2.0350] (Revised 3/2/16) [PDF]
  • Protocol Violation Review [C2.0400] (Revised 8/19/09) [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 10/30/17) [PDF]

Special Requirements

  • Informed Consent [C3.0050] (Revised 8/28/17) [PDF]
  • Protection of Vulnerable Subjects [C3.0100] (Revised 2/26/14) [PDF]
  • Medical Device Clinical Investigations, Compassionate Use, and Treatment IDE [C3.0150] (Revised 12/1/17) [PDF]
  • Humanitarian Use Device (HUD) [C3.0200] (Revised 7/20/11) [PDF]
  • Emergency Use [C3.0250] (Revised 12/1/17) [PDF]
  • Expanded Access Program (EAP) for Drugs [C3.0300] (Revised 11/3/17) [PDF]
  • Data and Safety Monitoring Plan [C3.0350] (Revised 7/18/12) [PDF]
  • NCI CIRB Review [C3.0400] (Revised 4/25/14) [PDF]

Recordkeeping and External Reporting

  • Minutes of IRB Meetings [C4.0050] (Revised 7/29/11) [PDF]
  • Inspections by Regulatory Agencies [C4.0100] (Revised 7/29/11) [PDF]
  • Mandated Reporting to External Agencies [C4.0150] (Revised 9/4/14) [PDF]
  • Study Closure [C4.0200] (Revised 7/24/15) [PDF]
  • IRB/ORI Recordkeeping [C4.0250] (Revised 7/29/11) [PDF]

Quality Improvement & Assessment

  • Directed On-Site Review [C5.0050] (Revised 7/29/11) [PDF]
  • PI Self-Assessment Review [C5.0150] (Revised 8/19/09) [PDF]
  • Administrative Assessment Review [C5.0200] (Revised 5/14/14) [PDF]

Coordination

  • Institutional Biosafety Committee (IBC)/IRB Coordination [C6.0100] (Revised 2/15/17) [PDF]
  • Investigational Drug Service (IDS)/IRB Coordination [C6.0350] (Revised 5/8/15) [PDF]
  • Markey Cancer Center (MCC)/IRB Coordination [C6.0400] (Revised 5/5/14) [PDF]
  • Radiation Safety Officer (RSO) Coordination [Use of Radioactive Materials] [C6.0500] (Revised 8/7/09) [PDF]
  • Office of Sponsored Projects Administration (OSPA)/IRB Coordination [C6.0600] (Revised 8/30/17) [PDF]
  • Investigator Conflict of Interest/OSPA/IRB 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 7/27/12) [PDF]
  • Federal Agency "Specific" Requirements IRB/ORI Coordination [C6.0900] (In Effect 10/14/12) [PDF]
  • Center for Clinical and Translational Science IRB/ORI Coordination [C6.0950] (In Effect 4/8/13) [PDF]