Office of Research Oversight ORO VA Cooperative Studies Program

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Office of Research Oversight (ORO)VA
Cooperative Studies Program

• Research Compliance Education Program

July 8, 2009Tom Puglisi, PhD, CIPChief
OfficerJoan Porter, MSc, DPA, MPH, CIP,
CIPP/GDeputy Chief Officer
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Executive Career Field (ECF)Performance Plan
Requirements for RCOs FY 2009

• Specifies activities and qualifications for at
  least one full time RCO who must report directly
  to the Director of each VA facility conducting
  research. There are also some VISN-level RCOs.
• Requires dedicated auditing, monitoring, and
  reporting on the conduct of all VA research
  (including human subject research, animal
  research, basic biomedical research,
  health services research, and
  research safety).

( Research Compliance Officer)
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RCO Requirement

• ECF specified all RCOs had to be in place by
  Dec. 31, 2008.
• This did not happen by the deadline hiring
  delays, transitions, waiver requests, and so
  on.
• All VA facilities with research have an approved
  RCO, but may have acting RCOs and are awaiting
  approval to be part-time.

( Research Compliance Officer)
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Why do we need RCOs?

• To ensure compliance in VA research for excellent
  achievement in research
• To protect and benefit our Veterans to the
  greatest extent possible
• Generated with stimulus from Congress, the
  Secretary, and VHA leadership

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Who can be an RCO?

• No researchers (within their own VA facility)
• No voting members of IRBs, IACUCs, RD
  Committees
• No Associate Chiefs of Staff for Research and
  Development
• No Administrative Officers for RD
• No other Research Office Staff

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RCO can be a part-time RCO ONLY with the
approval of the Under Secretary for Health!
Memo signed by the Under Secretary for Health
on Friday, January 9, 2009
How to Request a Waiver
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Waiver for Full-Time RCO

• Case by case basis for RCO position to be either
  part-time or combined with other related duties
• Facility Director goes through the VISN Director
• Then to CRADO and Chief Officer, ORO
• Through Deputy Under Secretary for Health for
  Operations and Management
• Through Principal Deputy Under Secretary for
  Health
• Then to the Under Secretary for Health for
  approval/disapproval

• Description and justification are required

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ORO Structure
New positions were added to help establish the
RCO Education Program
All positions have been filled but staff not here
yet!
Organizational Chart
Assoc. Director for Research Integrity and
Assurance
Assoc. Director for Research Compliance Officer
EducationPaula WatermanVacantVacantLynda Poore
Chief OfficerJ. Thomas PuglisiDeputy Chief
OfficerJoan P. Porter
Assoc. Director for Research Safetyand Animal
Welfare
Northeastern Regional OfficeBedford, MA
Mid-Atlantic Regional Office Washington, DC
Southern Regional Office Decatur, GA
Western Regional OfficeMoreno Valley, CA
Midwestern Regional OfficeHines, IL
Dated 12/10/07
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Special Assistance Group

• A special group of experienced RCOs who help ORO
  Central Office in developing audits, policies,
  advice, and documents for website for RCOs.
• Darlene Krueger, MBA, RN, CCRA, Chief Auditing
  and Training, Albuquerque CRPCC, has been a major
  help in audits and educational material!

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Ensuring Compliance

• Each RCO serves as local resource for
  regulations, policies, memoranda, alerts, and
  other VA and Federal requirements related to
  research compliance.
• Each RCO serves as a non-voting member of the
  Institutional Review Board, Institutional Animal
  Care and Use Committee, Subcommittee on Research
  Safety, and Research and Development Committee.

• Each RCO provides education to investigators and
  research staff regarding regulations and policy
  requirements.

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Informed Consent Audits

• Annual audits of all active studies is to ensure
  that informed consent has been properly
  obtained and documented yearly for each subject
  since the previous informed consent audit.

Sample Informed Consent Audit Template
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Regulatory Audits

• Regulatory compliance audits for all active
  studies (that started in CY 2008 or after) at
  least every 3 years

VHA Triennial Regulatory Compliance Audit
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VHA Triennial Regulatory Compliance Audit
Good Clinical Practice and Human Research
Protection Audit Work Sheet
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Animal and Biosafety Triennial Audits

• Our newest audit tools released June 2009

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Annual Summary of RCO Informed Consent and
Regulatory Audits

• The first go-around of reporting RCO audits
  results NOW!
• July 1, 2009 Each Facility Director
  Certification of Research Oversight must include
  a summary of RCO informed consent and regulatory
  audits conducted between January 1, 2009, and May
  31, 2009.

• The summary of Informed Consent Audits must
  include all human subject protocols open at any
  time between January 1, 2009, and May 31, 2009.
• The summary of regulatory audits could include
  protocols that began after January 1, 2008, and
  ended between January 1, 2009, and May 31,
  2009, or later, but is not
  absolutely required this first year as experience
  is developed.

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Facility Directors Annual Certification (2009)
Page 1 of 7
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RCO Audit Summary
Page 6 of the Facility Directors Annual
Certification
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VHA Handbook 1058.01

• Requirements for Reporting Research Events to
  Facility Oversight Committees and the Office of
  Research Oversight
• See also VHA Directive 2008-064 regarding human
  subjects

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RCO Reporting of Noncompliance in VA Human
Research
Decision Chart
Example
See ORO Website!
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DRAFT RCO Checklist
Now on OROs website
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First Reporting PeriodJanuary 1,
2009throughMay 31, 2009Second Reporting
PeriodJune 1, 2009throughMay 31, 2010
Informed Consent Audits
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Communication is essential!

• Conducting monthly teleconference calls with
  RCOs
• Research Compliance Education page on ORO
  Website (http//vaww1.va.gov/oro/page.cfm?pg142)
• Q and A Section on Website (http//vaww1.va.gov/or
  o/page.cfm?pg149)
• RCO ListServ

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RCO WebPages
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SummaryWhat do RCOs do?
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Summary What do RCOs do? Cont.
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Need More Information?

• Call your RCO
• See OROs website at www1.va.oro.gov
• See VHA Handbook 1058.01, Requirements for
  Reporting Research Events to Facility Oversight
  Committees and the Office of Research Oversight
• Call ORO Central Office Staff
• Paula Waterman (202-266-4581 or email
  (Paula.Waterman_at_va.gov)
• Joan Porter (202-266-4576 or email
  Joan.Porter_at_va.gov)
• Lynda Poore (202-266-4575 or email
  Lynda.Poore_at_va.gov)