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Office of Research Oversight

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ORO Publications and Guidance

ORO Publications

VHA Directive 1058Responsibilities of the Office of Research Oversight (Mar 2017)

VHA Handbook 1058.01Research Compliance Reporting Requirements (Jun 2015)

Implementation Guidance

Summary of Major Changes

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

VHA Handbook 1058.02Research Misconduct (Feb 2014)

PowerPoint Presentation from March 13, 2014

VHA Handbook 1058.03Assurance of Protection for Human Subjects in Research (Nov 2014)

VHA Handbook 1058.04Debarments and Suspensions Based on Research Impropriety in VA Research (April 2013)

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1058.05: VHA Handbook 1058.05 ("VHA Operations Activities That May Constitute Research") dated October 28, 2011, was rescinded on January 4, 2019.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  Similar to the content previously included in the rescinded Handbook, the Program Guide continues to provide guidance on when an operations activity may also constitute research (which could necessitate obtaining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1058.06: VHA Handbook 1058.06 ("Research Conducted by Employees of VHA Program Offices") dated October 28, 2011, was rescinded upon issuance of VHA Directive 1200.05 ("Requirements for the Protection of Human Subjects in Research") on January 7, 2019.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