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ORO Publications and Guidance
ORO Publications
VHA Directive 1058: Responsibilities of the Office of Research Oversight (Dec 2021)
VHA Directive 1058.01: Research Compliance Reporting Requirements (Oct 2020)
- Summary of Major Changes - VHA Directive 1058.01 (Jul 2021)
- Table of Changes - VHA Directive 1058.01 (Nov 2020)
- Guidance on Information to Include in Reports to ORO (Feb 2022)
- Examples of Events in VA Animal Rsch Reportable to ORO (Jul 2021)
- Examples of VA Lab Safety & Security Events Reportable to ORO (Mar 2021)
- Examples of Events in VA Human Subjects Rsch that Constitute Serious or Continuing Noncompliance (Mar 2021)
- Guidance on Reporting Deficient HIPAA Authorizations (Mar 2021)
- Decision Chart: Reporting of Systematic Deficiencies and Noncompliance in VA Research (Mar 2021)
- Decision Chart: Reporting Human Deaths, Unanticipated Problems and Accident, Injury, Illness and Exposure in VA Reseach (Mar 2021)
- Guidance for RCOs and Research Review Committees on Reporting and Reviewing All Audit Results (Jan 2023)
VHA Directive 1058.02: Research Misconduct (Jul 2020)
VHA Directive 1058.03: Assurance Protection for Human Subjects Research (Sep 2020)
- Summary of Major Changes - VHA Directive 1058.03 (Sep 2020)
- Table of Changes - VHA Directive 1058.03 (Sep 2020)
- MOU Checklist (Dec 2020)
- Frequently Asked Questions: VHA Directive 1058.03, FWAs, IRB Registration and MOUs for IRB Reliance (Feb 2023)
- Federalwide Assurance (FWA) Registration Instructions
- VA Addendum to FWA
VHA Directive 1058.04: Debarments and Suspensions Based on Impropriety in VA Research (Nov 2019)
ORO Guidance
- ORD-ORO Joint Guidance on Semi-annual Reviews of the ACUP (Sep 2016)
- Waiver of Requirement for a Full Time RCO (Dec 2020)
Other Publications and Guidance
VHA Office of Research and Development (ORD) Policies and Guidance
