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	914KB
101	VA Central IRB Authority, Responsibilities, and Activities	378KB
102	VA Central IRB Membership Policies	878KB
103	Managing Conflict of Interest	495KB
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	1.4MB
106	Research Involving Vulnerable Populations and Other Special Classes of Participants	373KB
107	Requests for Exemption Review and Determination	791KB
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	1.5MB
113	Requests to Amend or Modify an Approved Project	340KB
114	Reportable Adverse Events and Unanticipated Problems in Research	764KB
115	Recording and Distribution of VA Central IRB Meeting Minutes	280KB
116	Maintenance of VA Central IRB Files	282KB
117	Investigational Drugs, Devices, and Biologics	112KB
118	Serious and Continuing Noncompliance	202KB
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	1MB
124	VA Central IRB HIPAA Responsibilities	277KB
125	Reportable Action Reporting	137KB
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