Office of Research & Development

 

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 TitlePDF size
100Veterans Health Administration Central Office (VHACO) Human Research Protection Program Overview and Structure387KB
101VA Central IRB Authority, Responsibilities, and Activities387KB
102VA Central IRB Membership Policies266KB
103Managing Conflict of Interest214KB
104Application Requirements for New Projects Funded or Sponsored by the Office of Research and Development (ORD) Services2.7MB
105Informed Consent Process Requirements1.4MB
106Research Involving Vulnerable Populations and Other Special Classes of Participants1.8MB
107Requests for Exemption Review and Determination791KB
108VA Central IRB Convened Meeting Preparation2MB
109Review of Projects by the Convened IRB348KB
110Expedited Review Process363KB
111VA Central IRB Communications with Investigators and Local Participating Sites748KB
112Continuing Review and Approval Requirements1.5MB
113Requests to Amend or Modify an Approved Project340KB
114Reportable Adverse Events and Unanticipated Problems in Research764KB
115Recording and Distribution of VA Central IRB Meeting Minutes280KB
116Maintenance of VA Central IRB Files369KB
117Investigational Drugs, Devices, and Biologics164KB
118Serious and Continuing Noncompliance168KB
119Suspensions and Terminations80KB
120Community Outreach87KB
122Determinations of Human Subjects Research and Institutional Engagement609KB
123Evaluation and Quality Improvement of the VA Central IRB1MB
124VA Central IRB HIPAA Responsibilities277KB
125Reportable Action Reporting150KB
126Protocol Deviations and Violations250KB
128Definitions Used in VA Central IRB SOPs117KB
200Logistical Preparations for a Convened IRB Meeting488KB
201Maintaining VA Central IRB Membership Files62KB