OVERVIEW: OFFICE OF RESEARCH OVERSIGHTORO ORD: AO

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OVERVIEW OFFICE OF RESEARCH
OVERSIGHT(ORO)ORD AO Compliance Training
MeetingFebruary 27, 2004
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Office of Research OversightORO Formerly ORCA

• David A. Weber, Ph.D., FACNP
• Acting Chief Officer, ORO
• Department of Veterans Affairs

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• Congressional Legislation
• Mission
• Oversight Responsibility
• Compliance Reviews
• Regional Offices
• Required Reporting to ORO
• New AE Reporting Policy
• Research Misconduct, Assurance Program

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ORCA ????OHRO?ORO(1999 ???2004)

• Few changes in mission responsibilities
• Legislated mandate

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Legislation in Support of ORO

• 11/19/2003 - S.1156 Passed Senate
• 11/21/2003 - Cleared for White House
• 11/25/2003 - Presented to President
• 12/6/2003 President Signs Pub. L. 108(170)

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Veterans Health Care, Capital Asset, and Business
Improvement Act of 2003 Pub. L. 108(170)

• Title IV-OTHER MATTERS
• Sec. 401. Office of Research Oversight in
  Veterans Health Administration
• (a) Statutory Charter.-(1) Chapter 73 is amended
  by inserting after section 7306 the following new
  section

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7307. Office of Research Oversight(a)
Requirement for Office.-(1) There is in the
Veterans Health Administration an Office of
Research Oversight (hereinafter in this section
referred to as the Office). The Office shall
advise the Under Secretary for Health on matters
of compliance and assurance in human subjects
protection,..
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ORO Mission

• Advise USH on matters of compliance and assurance
  related to human subjects and animal welfare,
  research safety, and research misconduct.

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ORO Actions

• Office monitors, reviews, and investigates
  regulatory compliance and assurance with respect
  to human subjects protections, animal welfare,
  research safety, and provides oversight
  management of research misconduct in medical
  research

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ORO OVERSIGHT RESPONSIBILITY

• Human Subjects Protections
• Oversee compliance with protections established
  by Common Rule (38 CFR Part 16), other federal
  regulations, and VHA policies (e.g. ORD Handbook
  1200.5).
• Manage VHA facilities Assurances and MOUs
• Review accreditation survey reports for
  regulatory compliance

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ORO OVERSIGHT RESPONSIBILITY

• Animal Welfare
• Regulatory oversight of VHA Animal Care Use
  Programs (M-3, P-1, C 12/ VA HB 1200.7)
• Allegations of animal research non-compliance
• Ensure animal welfare in research

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ORO OVERSIGHT RESPONSIBILITY

• Research Safety
• Safety of VHA research personnel and laboratory
  physical security
• Compliance with federal regulations, VHA policies
  and procedures, and applicable NIH/CDC/USDA
  guidelines

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ORO OVERSIGHT RESPONSIBILITY

• Research Misconduct
• Investigations into allegations of research
  misconduct (falsification, fabrication,
  plagiarism (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 ON-SITE REVIEWS

• Types of Reviews
• Routine and For-Cause

• Reviews Focus on Regulatory Compliance
• Identify deficiencies

• End Product/Outcome
• Site visit report with recommendations
• Facility develops action plan
• Assurance Restricted/Suspended
• Continuous follow-up until remedial action
  complete

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For Cause On-Site Reviews

• Investigation of reported or alleged instances of
  noncompliance with the laws, regulations,
  policies, and/or procedures governing research
• Includes human subjects protections, animal
  welfare, and research safety
• Remediation includes corrective actions
• Teams of 2-5 members for 2-4 days depending on
  the severity and scope of noncompliance

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Routine On-Site Reviews

• To assess compliance and assurance with the laws,
  regulations, policies, and procedures governing
  research
• Rotate thru VHA facilities with research programs
• May involve human subjects protections, animal
  welfare, research safety, and research misconduct
• Remediation may include corrective actions
• Teams of 2-5 members for 2-4 days depending on
  and scope of studies, and findings

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What is OROs Organizational Structure ?

• Central Office Component
• Manage ORO
• Strategic guidance, coordination, and oversight
• Regional Offices
• Field operational units
• Geographically distributed
• 5 locations across the country
• Oversee RCA for 21 VISNs
• Oversee RCA for 115 VAMC Res. Prog. with
  Assurances VAMC affiliates

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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

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

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Regional Office Directors

• Midwestern RO
• Karen M. Smith, PhD
• [phone]
• Western RO
• Paul St. J. Hammond, MD, DPhil
• [phone]

• Northeastern RO
• Richard J. DAugusta, RPh, MPA
• [phone]
• Mid-Atlantic RO
• Min-Fu Tsan, MD, PhD
• [phone]
• Southern Regional Office
• David J. Miller, PhD, FAClinP
• [phone]

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ORO Regional Offices
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ORO Regional Office

• Answers questions about regulations, policies,
  directives, best practices.
• Assists with concerns about incidents that may
  pose compliance problems
• Helps locate information resources
• Conducts routine and for cause review
• And so on

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WHAT TO REPORT TO ORO

• Date November 12, 2003
• From Acting Chief Officer, Office of Research
  Oversight (ORO) (10R)
• To Institutional Officials of VHA Facilities
  Conducting or Supporting Research

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WHAT TO REPORT TO OROMEMORANDUM

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

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REPORTING AEs in RESEARCH TO ORO(Handbook in
Draft)

• Identifies AEs to be reported to ORO
• Provides timelines for reporting
• Indicates information to be reported

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IN PROGRESS

• Research Misconduct Handbook
• Assurance Handbook

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ORO TAKE HOME MESSAGE (1)
ORO advises USH on compliance and assurance ORO
responsible for regulatory compliance in
research ORO is receptive to questions
(hypothetical or real) on research compliance
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ORO TAKE HOME MESSAGE (2)

• ORO requires reporting What to Report to ORO?
• ORO facilitates/maintains assurances with VA
  facilities
• ORO supports accreditation
• Watch for New ORO Handbooks

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THE END