FEDERAL UPDATE OFFICE OF RESEARCH OVERSIGHT ORO DEPT. OF VETERANS AFFAIRS David A. Weber, Ph.D., FAC

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FEDERAL UPDATEOFFICE OF RESEARCH OVERSIGHT
(ORO) DEPT. OF VETERANS AFFAIRS David A.
Weber, Ph.D., FACNPChief OfficerFriday,
November 12, 2004
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FACILITIES AND PERSONNEL

• 118 VAMCs VAHCSs
• gt3000 Investigators
• Four Research Services
• Clinical Science RD (CSRD)
• Biomedical Research RD (BLRD)
• Health Services RD (HSRD)
• Rehabilitation RD (RRD)
• Overall Research Budget1.6 B (est. 2004)

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ORO OVERSIGHT RESPONSIBILITIES

• HUMAN SUBJECTS PROTECTIONS
• RESEARCH MISCONDUCT
• ANIMAL WELFARE
• RESEARCH SAFETY

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ORO OVERSIGHT RESPONSIBILITY

• Human Subjects Protections
• Oversee compliance with protections established
  by Common Rule following 38 CFR Part 16, VHA HB
  1200.5, other VHA policies, and federal
  regulations.
• Manage VAMCs Assurances and MOUs

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ORO OVERSIGHT RESPONSIBILITY

• Human Subjects Protections
• Review accreditation survey reports for
  regulatory compliance
• Oversee and guide investigations of allegations
  of research misconduct (FFP in proposing,
  performing, or reviewing research, or in
  reporting research results).
• M-3, P-1, C-15/ HB 1200.14

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ORO REGIONAL OFFICES
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ORO REGIONAL OFFICES

• Northeastern
• Bedford, MA
• VISNs 1, 2, 3
• Mid-Atlantic
• Washington, DC
• VISNs 4, 5, 6, 9, 10
• Southern
• Decatur, GA
• VISNs 7, 8, 16, 17

• Mid-Western
• Hines, IL
• VISNs 11, 12, 15, 19, 23
• Western
• March AFB, CA
• VISNs 18, 20, 21, 22

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ORO REGIONAL OFFICES

• Conduct routine and for cause reviews
• Participate in QA reviews
• Oversee reporting to ORO
• Monitor site action plans
• Review compliance issues by phone, fax, etc.
• Answer questions about regulations, policies,
  directives, best practices
• Helps locate information/resources on compliance

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ROUTINE ON-SITE REVIEWS

• Consultative assessment of CA with the laws,
  regulations, policies, and procedures governing
  research
• Rotate thru VHA facilities with research programs
• Site visit may require action plan
• Follow-up if action plan required

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SYSTEM WIDE QA PROJECT

• ORO review of IRB minutes
• IRB minutes for 5 month period
• Nearing completion of all VA IRB minutes
• Will provide individual/system findings
• Next step to review minutes of affiliates

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WHAT TO REPORT TO OROMEMORANDOM

• Identifies issues VHA facilities must report to
  ORO as required by various Federal regulations
  and VHA policies.
• http//www.va.gov/oro/
• November 12, 2003

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WHAT TO REPORT TO ORO

• Findings of serious or continuing noncompliance
  with regulations for protection of human subjects
  or IRB requirements
• For cause suspension or termination of IRB
  approval
• Change in status of FWA or IRB, IO, IRB members
• Changes in shared responsibilities in HRPP MOU
  with academic affiliate or VA facility
• AEs- new AE policy in VHA concurrence process

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WHAT TO REPORT TO ORO

• Research Misconduct (RM)
• All initiations of inquiries and investigations
  of RM (FFP in proposing, performing, or reviewing
  research, or in reporting research)
• Copies of inquiry and investigation reports
• All adjudications (w/wo findings of RM)

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THE END