ORO Publications and Guidance
ORO Publications
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Directive 1058.03, Assurance of Protection for Human Subjects in Research, dated September 17, 2020, both of which were rescinded by the issuance of revised VHA Directive 1058.
- 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 Deficient HIPAA Authorizations (Mar 2021)(to be updated)
- Guidance for RCOs and Research Review Committees on Reporting and Reviewing All Audit Results (Jan 2023)(to be updated)
- Federal Wide 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.