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 As indicated in the current version of VHA Handbook 1200.05 (November 12, 2014), “All sections of rescinded VHA Handbook 1200.05, dated May 2, 2012, must be followed until the VA facility implements the requirements of this new Handbook, but no later than March 12,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.
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)
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.