VA Central IRB: Standard Operating Procedures (SOPs)
Below are the most current versions of the VA Central IRB Standard Operating Procedures (SOPs). These SOPs will be updated as changes occur. Guidance on incorporating VA Central IRB policies and procedures into local VA facilities that use the VA Central IRB can be found in Policies and Procedures.
Where applicable, VA Central IRB forms are attached to the SOPs for reference only in conjunction with that specific SOP. To download a VA Central IRB form, please reference VA Central IRB forms.
Any comments concerning these SOPs can be forwarded to the VA Central IRB e-mail address at va.central.irb@va.gov.
| Standard Operating Procedures (SOPs) |
| SOP # | Title | PDF size |
| 100 | Veterans Health Administration Central Office (VHACO) Human Research Protection Program Overview and Structure | 900KB |
| 101 | VA Central IRB Authority, Responsibilities, and Activities | 322KB |
| 102 | VA Central IRB Membership Policies | 781KB |
| 103 | Managing Conflict of Interest | 358KB |
| 104 | Application Requirements for New Projects Funded or Sponsored by the Office of Research and Development (ORD) Services | 2.7MB |
| 105 | Informed Consent Process Requirements | 1MB |
| 106 | Research Involving Vulnerable Populations and Other Special Classes of Participants | 373KB |
| 107 | Requests for Exemption Review and Determination | 572KB |
| 108 | VA Central IRB Convened Meeting Preparation | 2MB |
| 109 | Review of Projects by the Convened IRB | 348KB |
| 110 | Expedited Review Process | 363KB |
| 111 | VA Central IRB Communications with Investigators and Local Participating Sites | 748KB |
| 112 | Continuing Review and Approval Requirements | 558KB |
| 113 | Requests to Amend or Modify an Approved Project | 340KB |
| 114 | Reportable Adverse Events and Unanticipated Problems in Research | 518KB |
| 115 | Recording and Distribution of VA Central IRB Meeting Minutes | 330KB |
| 116 | Maintenance of VA Central IRB Files | 282KB |
| 117 | Investigational Drugs, Devices, and Biologics | 112KB |
| 118 | Serious and Continuing Noncompliance | 172KB |
| 119 | Suspensions and Terminations | 80KB |
| 120 | Community Outreach | 87KB |
| 122 | Determinations of Human Subjects Research and Institutional Engagement | 609KB |
| 123 | Evaluation and Quality Improvement of the VA Central IRB | 845KB |
| 124 | VA Central IRB HIPAA Responsibilities | 277KB |
| 125 | Reportable Action Reporting | 92KB |
| 126 | Protocol Deviations and Violations | 180KB |
| 128 | Definitions Used in VA Central IRB SOPs | 117KB |
| 200 | Logistical Preparations for a Convened IRB Meeting | 488KB |
| 201 | Maintaining VA Central IRB Membership Files | 62KB |
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