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MISSION STATEMENT

The Office of Research Oversight (ORO) serves as the primary VHA office in advising the Under Secretary for Health on all matters of research compliance and assurance for human subjects protections, animal welfare, research safety, and research misconduct.  ORO promotes and enhances the responsible conduct of research in these areas in conformance with laws, regulations, and policies.

FUNCTIONAL STATEMENT

This office reports to the Under Secretary for Health.  Under the direction of its Chief Officer, ORO serves as primary advisor to the Under Secretary for Health on all matters of research compliance and assurance for human subjects protections, animal welfare, research safety, and research misconduct.  ORO oversees inquiries/investigations of allegations of research misconduct and conducts reviews of allegations as appropriate.

The ORO Central Office is responsible for the overall accomplishment of its mission, by providing direction, guidance, and oversight to its Regional Offices that support the office’s mission.

ORO coordinates its activities with several Central Office components, especially the Office of Research and Development and the National Center for Ethics in Healthcare.  ORO maintains productive and effective linkages with the Veterans Integrated Services Networks (VISNs), and VHA facilities, primarily through the Regional Offices.

Central Office-Specific Functions:

• Develops, implements, evaluates operational policies and procedures related to assessing facilities’ compliance with laws, regulations, and policies related to 1) human subjects protections; 2) animal welfare; 3) research safety; and 4) research misconduct.
  
  
• Identifies issues arising from research compliance and assurance activities related to the responsible conduct of research and coordinates resolution with the pertinent VHA offices.
  
  
• Manages the program for the VHA human subject assurance program required of VHA to facilities that commits them to abide by regulations that govern research involving human subjects.
  
  
• Participates in the development of laws, regulations, and policies concerning the integrity of research under the purview of the Office of Research and Development.
  
  
• Works with other appropriate VA and Federal offices to provide guidance on policy and procedures and develop laws, regulations, and policies related to the integrity of research conducted throughout VHA.
  
  
• Serves as the primary liaison for VA research compliance and assurance issues to various external groups, including other government offices/agencies, the health professions, related academic centers, and professional organizations.
  

Regional Offices-Specific Functions:

• Implements ORO’s mission, roles, and functions and coordinates with VISNs to promote compliance with policies concerning research integrity and research misconduct.
  
  
• Conducts both routine and for-cause reviews of VHA research programs to assess compliance with policies and procedures; provides oversight to ensure VA facilities initiate written appropriate "action plans" to correct any problems and deficiencies identified by the VA and other Federal oversight bodies.
  
  
• Assists in the identification of problem areas and emergent research compliance issues, proposes initiatives, and refers appropriate issues to Central Office to coordinate with other appropriate VA offices.
  
  
• Serves as sources of subject matter expertise in assigned areas of program emphasis.