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Office of Research Oversight

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ORO Publications and Guidance

ORO Publications

VHA Directive 1058: Responsibilities of the Office of Research Oversight (Feb 2009)

VHA Handbook 1058.01Research Compliance Reporting Requirements (Jun 2015)

Implementation Guidance

Summary of Major Changes

Summary of Requirements for Reporting Research Incidents

Examples of Serious Problems and Serious Noncompliance in VA Human Research and 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 1058.05VHA Operations Activities That May Constitute Research (Oct 2011)

PowerPoint Presentation 

Sample Format for Documentation of Non-Research Activities (Presentations)

Sample Format for Documentation of Non-Research Activities (Publications)

Decision Chart for Determining VHA Operations Activities That May Constitute Research

Official Authorized to Provide Documentation of VHA Program Office Non-Research Operations Activities

When Program Office, Network, or Facility officials are unable to reach a determination about the research versus non-research status of an activity, VHA Handbook 1058.05 §6e encourages requesting joint, written guidance from ORO and ORD.  Such requests should be forwarded electronically to the ORO Executive Director and must include a complete copy of the project plan, including the purpose and methodology and, where applicable, any proposed publication(s).  The ORO Executive Director will convey the request and required supporting materials to ORD, and after reaching a consensus, forward the joint ORO-ORD guidance to the requester. 

VHA Handbook 1058.06Research Conducted by Employees of VHA Program Offices (Oct 2011)

PowerPoint Presentation 

Sample Format for Documentation of Program Office Research 


ORO Guidance

Importance of SOPs for Facility Human Research Protection Programs (January 12, 2015)

The current version of VHA Handbook 1200.05 (issued November 12, 2014, for implementation no later than March 12, 2015) provides facilities with increased flexibility in operating their Human Research Protection Programs (HRPPs). As a result, the facility’s local standard operating procedures (as required under VHA Handbook 1200.01 §§11.e & 14.d) will become ever more critical for ensuring HRPP effectiveness.

ORO strongly encourages facilities to evaluate carefully the effectiveness of their current HRPP procedures before making wholesale changes based solely on the recent revisions to VHA Handbook 1200.05. It is important to remember that the extant requirements of related regulations (e.g., FDA regulations at 21 CFR 312 and 812) and VHA Handbooks (e.g., 1200.01, 1200.12, 1058.01, 1605.1), remain in effect even in instances in which VHA Handbook 1200.05 no longer references them. In addition, local procedures that are working well need not be abandoned simply because the Handbook no longer requires them. Maintaining an effective local program of protections for human research subjects remains the responsibility of every VA research facility and every VA investigator.

Interim ORO Guidance On Data Disclosure For Collaborative Studies and Update 

  • The Office of Research Oversight (ORO) developed interim guidance on data disclosures for collaborative research studies. The guidance clarifies current requirements for the disclosure of VA research data to academic affiliates and other non-VA entities for “collaborative” human subject research, including requirements related to the retention of VA research records, disclosure of data under the Health Insurance Portability and Accountability Act (HIPAA), data ownership, information security, “dual appointment” research investigators, and combining data collected at a VA site and an affiliate/collaborator site.
  • Interim Guidance PowerPoint Presentation 
  • Sample SOP and Protocol Application Form

Waiver of Requirement for a Full Time RCO


 

 Other Publications and Guidance