ORO Publications and Guidance
ORO Publications
VHA Directive 1058: Responsibilities of the Office of Research Oversight (Mar 2017)
VHA Handbook 1058.01: Research Compliance Reporting Requirements (Jun 2015)
Summary of Requirements for Reporting Research Incidents
Examples of Apparently Serious or Apparently Continuing Noncompliance in VA Human Research
Examples of Apparently Serious Problems in VA Research Information Security
Decision Chart for Reporting SAEs and Problems Involving Risk in Research
PowerPoint Presentation from July 14 & 16, 2015
ORO Interpretation - VHA Handbook 1058.01
VHA Handbook 1058.02: Research Misconduct (Feb 2014)
PowerPoint Presentation from March 13, 2014
VHA Handbook 1058.03: Assurance of Protection for Human Subjects in Research (Nov 2014)
VHA Directive 1058.04: Debarments and Suspensions Based on Impropriety in VA Research (November 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1058.05: VHA Handbook 1058.05 ("VHA Operations Activities That May Constitute Research") dated October 28, 2011, was rescinded on January 4, 2019.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 Similar to the content previously included in the rescinded Handbook, the Program Guide continues to provide guidance on when an operations activity may also constitute research (which could necessitate obtaining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1058.06: VHA Handbook 1058.06 ("Research Conducted by Employees of VHA Program Offices") dated October 28, 2011, was rescinded upon issuance of VHA Directive 1200.05 ("Requirements for the Protection of Human Subjects in Research") on January 7, 2019.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 (September 23, 2016)
Reporting Deficient HIPAA Authorizations (June, 22, 2016)
Waiver of Requirement for a Full Time RCO
Other Publications and Guidance
- Plan to Access the Results of VA-Funded Research (July 2015)
- PowerPoint presentation (Jan 2016)
- Sample Format for Data Access Management Plan (Feb 2016)
- Data Management and Access Plan FAQs (Mar 2016)
- VHA Directive 1200.05(1) (January 7, 2019, Amended March 3, 2020) — Requirements for the Protections of Human Subjects in Research
- VHA Office of Research and Development Policies and Guidance
