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ORO publications and guidance

VHA Directive 1058Office of Research Oversight (Nov 2024)

This revised directive sets forth the responsibilities of ORO; requires that certain research-related events be reported to ORO; establishes a requirement for VA medical facilities with research programs to appoint a VA medical facility Research Compliance Officer; and requires that each VA medical facility engaged in non-exempt human subjects research covered by the requirements of the Federal Policy for the Protection of Human Subjects hold a valid written assurance committing the facility to compliance with that Federal policy.  

NOTE:  This directive incorporates and streamlines content previously contained in VHA Directive 1058.01, Research Compliance Reporting Requirements, dated October 22, 2020, and VHA Directive 1058.03, Assurance of Protection for Human Subjects in Research, dated September 17, 2020, both of which were rescinded by the issuance of revised VHA Directive 1058. 

ORO checklists and audit tools

The Checklists below are tools produced by ORO to assist the VA research community (including investigators, administrators, and committee members and staff) in identifying and complying with current VA/VHA policies and procedures and other Federal requirements related to research.  Their internal use as a self-assessment instrument is not mandatory.  For example, VA research programs may choose to review or complete select checklists in preparation for an ORO site review, but unless otherwise directed by ORO, such checklist completion is not an expectation.  ORO will update these checklists as policies and other requirements are revised; therefore, periodic revisitation of this web page is advised, rather than relying on previously downloaded versions of the checklists which may become outdated over time.

The Research Compliance Officer (RCO) Audit Tools below are provided to assist RCOs in completion of required audits. RCOs are encouraged to use the ORO-provided audit tools; however, use of these specific forms or formats is not mandatory. Should RCOs choose to use a different audit tool format, they must audit, at a minimum, all the required information in the ORO-provided audit tools.

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