Attention A T users. To access the menus on this page please perform the following steps. 1. Please switch auto forms mode to off. 2. Hit enter to expand a main menu option (Health, Benefits, etc). 3. To enter and activate the submenu links, hit the down arrow. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links.

Office of Research Oversight

Quick Links

Veterans Crisis Line Badge
My healthevet badge
 

ORO Publications and Guidance

Important note:

All references to VHA Handbook 1200.05 in ORO documents on this website – including but not limited to Handbooks, Guidances, FAQs, Checklists and Audit Tools – refer to the May 2, 2012, version of VHA Handbook 1200.05, unless otherwise noted. As indicated in the current version of VHA Handbook 1200.05 (November 12, 2014), “All sections of rescinded VHA Handbook 1200.05, dated May 2, 2012, must be followed until the VA facility implements the requirements of this new Handbook, but no later than March 12, 2015.” Thus, the requirements of the May 2, 2012, version of VHA Handbook 1200.05 as listed in the ORO documents must be followed until the VA facility implements (i.e., by local SOP) the current version of the Handbook (no later than March 12, 2015). The relevant ORO documents on this website will be revised to reflect the requirements of the current version of VHA Handbook 1200.05 by March 12, 2015.

ORO Publications

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

VHA Handbook 1058.01: Research Compliance Reporting Requirements (Nov 2011)

VHA Handbook 1058.02: Research Misconduct (Feb 2014)

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

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

VHA Handbook 1058.05: VHA Operations Activities That May Constitute Research (Oct 2011)

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

 

 


ORO Guidance

ORO-ORD Frequently Asked Questions 

  • The Office of Research Oversight (ORO) and the Office of Research and Development (ORD) jointly developed a series of FAQs on Human Research Protection Programs (HRPPs).

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 

 


 Other Publications and Guidance

  • VHA Handbook 1200.05 - Requirement for the Protections of Human Subjects in Research (Revised Nov 2014)
  • The DRAFT Policy and Implementation Plan for Public Access to Scientific Publications and Digital Data from Research Funded by the Department of Veterans Affairs dated February 14, 2014, is undergoing further revision and will be posted at a later date.