The Revised ORO Research Safety Checklist

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The Revised ORO Research Safety Checklist
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ORO - Purpose

• The Office of Research Oversight (ORO) serves as
  the primary VHA office in advising the Under
  Secretary for Health on all matters of compliance
  and assurance regarding human subject
  protections, animal welfare, research safety and
  security, research data security, and research
  misconduct.

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ORO - Authority

• ORO promotes and enhances the responsible conduct
  of research in these areas in conformance with
  laws, regulations, and policies. In December 2003
  the President signed Public Law 108-170 that
  created by statute the Office of Research
  Oversight. The responsibilities of ORO are
  outlined in VA Directive 1058.

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ORO - Functions

• Perform program evaluations on site and remote
  reviews
• Identify non-compliances and monitor programs
  corrective actions
• Provide technical assistance to programs
• Interface with other VA Offices and federal
  agencies

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Technical Assistance

• Obtaining policy clarification when needed
• Responding to questions from the field
• Development of checklists and other tools for
  program self-assessments
• Participation in training events

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ORO Checklists

• Animal Welfare Checklist
• Checklist for Developing an MOU
• Facility Directors Research Oversight Checklist
  and Certification
• Human Research Protection Program (HRPP)
  Checklist
• Institutional Review Board (IRB) Checklist

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ORO Checklists

• Research and Development Committee Checklist
• Research Data Security Assessment Checklist
• Research Privacy Checklist
• Research Safety Checklist
• Security Checklist for BSL-2 and BSL-3
  Laboratories
• Security Checklist for BSL-3 Research Laboratory

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ORO Research Safety Checklist

• First developed in 2005 and released in 2006.
• Updated in 2007 to include additional criteria
  and references
• Scope expanded
• Other VA Offices and Programs were consulted

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Revised Checklist

• Research Safety Programs
• Subcommittee on Research Safety (SRS)
• Laboratory Safety General
• BSL-1 and ABSL-1 Laboratories
• BSL-2 and ABSL-2 Laboratories
• BSL-3 and ABSL-3 Laboratories
• Appendix A (Acronyms)
• Not in previous Checklist

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General Instructions

• Comprehensive format intended for modification
  to meet individual program requirements and needs
• Checklist criteria are generalizations the
  corresponding regulations or policies should be
  consulted if the precise meaning is not clear.
• Hazardous waste management must be considered in
  the context of state and local requirements.
• Criteria for BSL-1 through BSL-3 are provided
  the requirements for each level is in addition to
  the requirements for lower levels.
• Recommended source documents are listed.

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Self-Review Process

• Assemble appropriate source documents in advance.
• Assemble review team members.
• Review process
• Document Review
• Laboratory and Facility Inspection
• Interviews with Key Personnel

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Post-Review

• Evaluate findings and prioritize.
• Develop action plan with timeline.
• Involve research management, laboratory
  directors, and technical advisors, when
  appropriate.
• Monitor progress.
• Conduct follow-up reviews.

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Report to ORO

• Work-Related Injuries to Research Personnel
  Requiring More than Minor Medical Intervention or
  Leading to Serious Complications or Death
• Significant Work-Related Exposures of Research
  Personnel to Hazardous Materials
• For-Cause Suspensions or Terminations of Research
  by the Subcommittee for Research Safety (SRS) or
  Other Institutional Safety Committee

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Report to ORO

• Serious or Continuing Noncompliance with Federal
  Regulations or VHA Policies on Research Safety
  and Security, including
• VHA Handbook 1200.06
• VHA Handbook 1200.8
• VHA Directive 2003-030
• VHA Directive 2005-003
• 7 CFR 331
• 9 CFR 121
• 29 CFR 1910
• 29 CFR 1960

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Report to ORO

• Exposure, Release, Loss, or Theft of Hazardous
  Materials, including Select Agents Toxins
• Any Findings of Noncompliance from ORD, the
  National Health Physics Program, the Office of
  Inspector General, or Other VA offices
• Provide copy of official finding
• Provide copies of subsequent correspondence until
  issue is resolved

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Report to ORO

• Any Findings of Noncompliance from External
  Oversight Agencies for Research Safety and
  Security, including OSHA, NRC, CDC, USDA, NIH
  (hazardous materials/select agents/toxins/rDNA)
• Provide copy of official finding
• Provide copies of subsequent correspondence until
  issue is resolved

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How to Report

• Report promptly (as soon as possible)
• Report to Regional Office through Facility
  Director in writing (FAX, email, hard copy)
• Describe issue
• Describe any actions taken to address issue
• Copy the VISN Director
• Does not obviate the need to report to other
  oversight authorities

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• Office of Research Oversight
• http//www.1.va.gov/oro/
• 811 Vermont Avenue, N.W., Suite 574 (10R)
• Washington, D.C. 20420
• PHONE [phone]
• FAX [phone]

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• Questions?