2013 Facility Director's Certification of Research Oversight
May 31, 2013:
The 2013 Facility Director's Certification (FDC) of Research Oversight is now available. This year's FDC is comprised of two documents, the Checklist of Research-Related Requirements and the Summary of Research Program Quantitative Data. These and other accompanying documents may be downloaded at: http://vaww.vha.vaco.portal.va.gov/sites/ORO/RCO/2013%20Facility%20Directors%20Certification%20of%20Research/Forms/AllItems.aspx.
Revised May 7, 2007
This checklist is based on the revised VHA Handbook 1200.05 (October 15, 2010) which becomes effective March 31, 2011. Please note that this checklist replaces the previous HRPP and IRB checklists (below).
This checklist may be used for VA/Academic Affiliate IRB arrangements and also for VA/VA IRB arrangements. It contains elements that ORD and ORO believe need to be discussed between the parties when MOUs are drafted and should be documented in the MOU.
May 25, 2009
This resource is provided by ORO for technical assistance to VA research facilities regarding the role of the RCO, in order to assist facilities in assessing their compliance with regulations and policies related to the role of the RCO, including but not limited to the VHA Handbook 1058.01 and guidance posted on the ORO website and the ORO Technical Assistance SharePoint site.
Revised February 2013
This new Checklist was designed to assist Privacy Officers and Information Security Officers in their review of VHA research protocols. Please also see the accompanying Instructions for Use
and Research Checklist Memorandum
. Please note that the use of this Checklist is highly encouraged but not mandatory.
This checklist has been prepared as a self-assessment tool for the evaluation of VHA Research Safety Programs.
Language has been modified in item 6: bullet two, page 3, now indicates that "if the lab houses hazardous agents and/or SATS as defined by 1200.06, the R&D Committee must review the status of personnel granted access to VA research labs at least semiannually including, among other criteria, visa status." (underscoring supplied to denote language modification.) (September 5, 2007)
Please also refer to the memorandum from the ORO Chief Officer to the Directors of facilities with BSL-3 Research Laboratories, which indicates that most BSL-3 Research Laboratories will be visited by ORO staff every other year for a security inspection; facilities will conduct their own inspections each year that no ORO visit is conducted and submit a report to ORO. (March 21, 2007)