Brief Overview Compliance with VHA Handbook 1200.1,

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• Brief Overview Compliance with VHA Handbook
  1200.1,
• The Research and Development (RD) Committee
  Handbook

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• March 2, 2007
• VHA Handbook 1200.1
• THE RESEARCH DEVELOPMENT (RD) COMMITTEE
  HANDBOOK

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• March 2, 2007
• VHA Handbook 1200.1
• THE RESEARCH DEVELOPMENT (RD) COMMITTEE
  HANDBOOK
• The provisions of the Handbook must be
  implemented no later than July 31, 2007.

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ORO Reviews Conducted January 1-August 22, 2008

• Both routine and for cause reviews, where there a
  final report was generated
• 30 sites visited, with review of RDC occurring
  at 12 sites
• All 12 reports that included RDC inspection had
  findings related to compliance with VHA Handbook
  1200.1.
• A specific part of the Handbook may be cited more
  than once, depending on what was found.

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Summary of Handbook sections cited and number of
citations

• 2. BACKGROUND AND SCOPE - 9
• 4. RESPONSIBILITIES OF THE MEDICAL CENTER
  DIRECTOR 6
• 5. RESPONSIBILITIES OF THE INVESTIGATOR 1
• 6. MEMBERSHIP - 32

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Summary of sections cited and number of citations

• 7. CONFLICT OF INTEREST 3
• 8. SUBCOMMITTEES OF THE RD COMMITTEE 16
• 9. RD COMMITTEE RESPONSIBILITIES RELATED TO THE
  FACILITYS RESEARCH PROGRAM 32

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Summary of sections cited and number of citations

• 10. RD COMMITTEE RESPONSIBILITIES FOR THE REVIEW
  OF RESEARCH 18
• 11. RD COMMITTEE OPERATIONS 12
• 12. RD COMMITTEE RECORDS - 3

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Section cited and number of citations

• 6.j. Voting members are appointed by the medical
  center Director in writing and serve terms of 3
  years. Members may be reappointed without any
  lapse in time if it is deemed in the Committees
  best interest. If the RD Committee is the RD
  Committee for a second VA facility, the medical
  center Director of the second facility must
  appoint its representative(s), when applicable.
  The terms of members must be staggered to provide
  partial change in membership annually. - 8

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Section cited and an example of citations about
6.j noncompliance

• The RDC members were not appointed in writing
  by the MCD to 3-year terms VHA Handbook 1200.1,
  6.j.
• Specifically, the AO/R appointed the RDC members
  to 1-year terms.
• emphasis mine

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Section cited and number of citations

• 6.k. Committee members, exclusive of ex-officio
  members, must elect a Chairperson on an annual
  basis. The Chairperson must be approved and
  officially appointed, in writing, by the medical
  center Director for a term of 1 year. The
  Chairperson may be reappointed without any lapse
  in time. The Chairperson must not simultaneously
  chair a subcommittee of the RD Committee. The
  Committee members, exclusive of ex-officio
  members, may elect a vice-Chairperson. The
  vice-Chairperson must also be approved and
  officially appointed, in writing, by the medical
  center Director for a term of 1 year. The
  vice-Chairperson may be reappointed without any
  lapse in time and must assume the
  responsibilities of the Chairperson when the
  Chairperson is not available. - 7

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Section cited and an example of citations about
6.k noncompliance

• The RDC Chair was not appointed in writing by
  the MCD for a term of 1 year VHA Handbook
  1200.1, 6.k.
• Specifically, the AO/R appointed the RDC Chair.
• emphasis mine

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Section cited and number of citations

• 9.c. Reviewing the budgetary and other resource
  needs of the RD Program, at least annually, and
  making appropriate recommendations regarding
  these needs. This review needs to include
  personnel, materials and supplies, space, capital
  equipment, training, and education - 6

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Section cited and an example of citations about
9.c noncompliance

• VHA Handbook 1200.1. paragraph 9.c., requires
  that the RD Committee review budgetary and other
  resource needs of the RD program at least
  annually, and make appropriate recommendations
  regarding these needs. This review needs to
  include personnel, materials and supplies,
  space, capital equipment, training, and
  education.
• ORO found that the RD Committee had not reviewed
  the budgetary needs for any medical research
  programs for fiscal year 2008.

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Section cited and number of citations

• 9.g. In fulfilling its responsibilities of
  ensuring the effective oversight of the research
  program and making appropriate recommendations to
  the medical center Director, the Committee needs
  to rely on a variety of information sources
  including activities of the RD Committee,
  quality assurance activities, reports to the
  committee by the ACOS for RD, AO for RD, or
  other research staff members, subcommittee
  reports, facility reports or activities, and
  other appropriate sources. - 18

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Section cited and an example of citations about
9.g noncompliance

• VHA Handbook 1200.1, paragraph 9.g.(1)-(8),
  requires the RD Committee to annually review the
  quality assurance of publications Without
  Compensation (WOC) appointments the scopes of
  practice and privileges of research employees
  Cooperative Research and Development Agreements
  (CRADAs), and other agreements in support of the
  research program or specific research projects
  the RSSP Research Safety and Security Program
  the Animal Care and Use Program (ACUP) and Human
  Research Protection Program (HRPP).
• ORO Found that the RD Committee had not
  conducted any of these annual reviews.

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Section cited and number of citations

• 11.f. SOPs or other written procedures must be
  maintained for all recurring processes. These
  processes include, but are not limited to review
  of protocols and/or communication with the
  medical center Director, the COS, investigators,
  and other committees and subcommittees. - 6

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Section cited and an example of citations about
11.f noncompliance

• VHA Handbook 1200.1, paragraph 11.f., requires
  SOPs or other written procedures be maintained
  for all recurring processes. These processes
  include, but are not limited to review of
  protocols and/or communication with the MCD, the
  COS, investigators, and other committees and
  subcommittees.
• ORO found that the RD Committee does not have
  any SOPs for recurring processes.

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Overall summary of findings

• Even though VHA Handbook 1200.1 required
  implementation by July 31, 2007, there are still
  significant compliance issues related to
  implementing the Handbook provisions. Facilities
  are urged to review their RDC operations to
  ensure they are in compliance with the Handbook.

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• Paula Squire Waterman, MS
• paula.waterman_at_va.gov
• Contact me if you want a copy of the
  presentation. Also, a copy will be posted on the
  ORO website