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

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

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David A. Weber, Ph.D., FACNP. Chief Officer. Friday, November 12, 2004. FACILITIES AND PERSONNEL ... Oversee compliance with protections established by Common ... – PowerPoint PPT presentation

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


1
FEDERAL UPDATEOFFICE OF RESEARCH OVERSIGHT
(ORO) DEPT. OF VETERANS AFFAIRS David A.
Weber, Ph.D., FACNPChief OfficerFriday,
November 12, 2004
2
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)

3
ORO OVERSIGHT RESPONSIBILITIES
  • HUMAN SUBJECTS PROTECTIONS
  • RESEARCH MISCONDUCT
  • ANIMAL WELFARE
  • RESEARCH SAFETY

4
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

5
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

6
ORO REGIONAL OFFICES
7
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

8
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

9
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

10
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

11
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

12
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

13
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)

14
THE END
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