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)
VHA Handbook 1058.05: VHA Handbook 1058.05 ("VHA Operations Activities That May Constitute Research") dated October 28, 2011, was rescinded on January 4, 2019. Related content was incorporated into VHA Office of Research & Development Program Guide 1200.21 ("VHA Operations Activities That May Constitute Research"), dated January 9, 2019. This Program Guide may be accessed at https://www.research.va.gov/resources/policies/handbooks.cfm. Similar to the content previously included in the rescinded Handbook, the Program Guide continues to provide guidance on when an operations activity may also constitute research (which could necessitate obtaining approvals from VA research oversight committees (e.g., Institutional Review Boards). Questions regarding VHA Office of Research & Development Program Guide 1200.21 should be referred to the VHA Office of Research & Development (email: VHACOORDRegulatory@va.gov).
VHA Handbook 1058.06: VHA Handbook 1058.06 ("Research Conducted by Employees of VHA Program Offices") dated October 28, 2011, was rescinded upon issuance of VHA Directive 1200.05 ("Requirements for the Protection of Human Subjects in Research") on January 7, 2019. Related content was incorporated into Appendix C of VHA Directive 1200.05, which can be accessed at: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8171. Questions regarding VHA Directive 1200.05 should be referred to the VHA Office of Research & Development (email: VHACOORDRegulatory@va.gov).
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)
- Coronavirus Disease 2019 (COVID-19) - Guidance from ORO Petaining to VA Research (intranet site)
Other Publications and Guidance
VHA Office of Research and Development (ORD) Policies and Guidance
- NOTE: For specific guidance on data management and access plans (DMAPs) for research funded by ORD, please visit the ORD Funding Webpage.
