
ORO resources
ORO publications and guidance
VHA Directive 1058: Office 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Directive 1058.03, Assurance of Protection for Human Subjects in Research, dated September 17, 2020, both of which were rescinded by the issuance of revised VHA Directive 1058.
VHA Directive 1058 guidance documents
- Summary of Major Changes Introduced by the Issuance of Revised VHA Directive 1058 (Dec 2024)
- Anticipated FAQs About the Issuance of Revised VHA Directive 1058 (Nov 2024)
- VHA Directive 1058 Timelines for Notifying ORO of Research-Related Events (Dec 2024)
- Guidance on Information to Include in Reports to ORO (Nov 2024)
- Examples of VA Animal Research-Related Events Typically Reportable to ORO (Dec 2024)
- Examples of VA Laboratory Research-Related Events Typically Reportable to ORO (Dec 2024)
- Examples of Events in VA Human Subjects Research that Constitute Serious or Continuing Noncompliance (Dec 2024)
- Guidance on Reporting of Research Compliance Officer (RCO) Audit Results (Apr 2025)
- Federalwide Assurance (FWA) Registration Instructions
VHA Directive 1058.02: Research Misconduct (Jul 2020)
This directive establishes requirements for handling allegations of research misconduct (i.e., fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results) involving VA research.
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.
HRPP and RDC
Research and Development Committee (RDC) Checklist (October 2025)
Investigational Pharmacy Checklist (December 2025)
VHA Directive 1200.05 Checklist (July 2025)
Research Safety and Animal Welfare
Animal Care and Use Program (ACUP) Checklist (July 2025)
Research Misconduct checklists
Research Information Security
Research Information Security Checklist (January 2026)
Research Compliance Officer Audit Tools
Research Compliance Officer (RCO) Checklist (September 2025)
2025-26 ORO Guidance for RCO Auditing and Training Requirements
2025-26 Animal Welfare Regulatory Audit Tool
2025-26 HRP Regulatory Audit Tool
2025-26 Informed Consent Audit Tool
2025-26 Research Safety Regulatory Audit Tool
2025-26 Optional FDC Tracking Tool
Active Studies and Audit History Tracking Tool
Summary Report of RCO QA of Reportable Events Template