Institutional Responsibilities for Research

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Institutional Responsibilities for Research

• K. Lynn Cates, MD
• Assistant Chief Research Development Officer

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Bottom Line

• Each VA facility must assume responsibility for
  all its research
• Medical Center Director and ACOS/RD have
  ultimate responsibility for what happens
• Research Office and RD Committee have oversight
  responsibility for local VA research
• VA has some requirements that are beyond those of
  other entities (e.g., affiliates)

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If men were angels, no government would be
necessary... A dependence on the people is, no
doubt, the primary control on the government
but experience has taught mankind the necessity
of auxiliary precautions. The Federalist No. 51
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The Medias Image of Investigators
Rebellious and disobedient, as he describes
himself has never fully lost his youthful
disrespect for authority and establishments.
New York Times, September 4, 2007
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Role of VA Local Accountability

• Maintain the publics trust
• Protect the Agency and Facility
• Allow innovation within safe boundaries
• Protects the Research Program Investigators
• Why documentation matters
• It shows the dots are connected
• Its what gets measured

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Institutional Official (IO)

• Medical Center Director (MCD) is the IO
• MCD responsible for all aspects of the RD
  program
• MCD is responsible for ensuring adequate
  resources administrative support. Examples
• Personnel
• Space
• Equipment
• Education training opportunities
• Etc.

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What is VA Research

• Research conducted by VA investigators
• On VA time (including WOC, IPA)
• Utilizing VA resources, including
• VA Research funds
• NPC funds
• Title 38 salary support
• CPRS
• Equipment (e.g., computers)
• On VA property (including space leased to VA)
• Implies VA is accountable (e.g., for
  research-related injuries)
• The RD Committee is responsible for approval and
  oversight of all VA research

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Scope of RD Committee

• Responsible through the COS to the Medical Center
  Director, for oversight of the research program
• ACOS/RD AO/RD assist the Committee with its
  duties

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Scope of RD Committee

• Responsible for maintaining high standards
  throughout the RD program including ensuring
• Scientific ethical quality of research
• Protection of human subjects
• Safety of personnel engaged in research
• Welfare of laboratory animals
• Security of VA data and VHA research laboratories

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Scope (Cont.)

• RD Committee approval must be obtained prior to
  initiating any research
• Applicable subcommittee approvals must be
  obtained prior to final RD Committee approval
• RD Committee may serve as the RD Committee of
  record for another VA
• MOU required
• Local accountability is key

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Complementary Roles
RD Committee
ACOS/Research Office

• Management operations
• Doing things right
• Day-to-day details
• Tactical
• Monitors ongoing operations

• Broad oversight review
• Doing the right things
• Long term picture
• Strategic
• Scans the broader environment for risks and
  opportunities

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RD Committee Membership

• Members expertise reflects the types of research
  being conducted
• At least 5 voting members
• All voting members must be full time or permanent
  part time compensated Federal employees
• At least 2 VA staff with clinical or
  administrative duties
• At least 2 investigators active in research
• If affiliated with a university, 1 member who
  holds an academic appointment is a Federal
  employee

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RD Committee Membership

• If conducting research involving investigational
  drugs, consider including 1 person from research
  pharmacy or Pharmacy service (voting or
  non-voting member)
• If serving as RD Committee of another facility,
  consider having 1 member from that facility
• Other voting or non-voting members as required

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RD Committee Membership

• Voting members may fill more than one role
• Ad hoc non-voting members may be used (OK if
  non-Federal if advice/facts only)
• Ex-officio, non-voting members include
• ACOS
• COS
• MCD
• Research Compliance officer
• AO

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RD Committee Membership

• Alternate members may be used
• If facility has centers, including Centers of
  Excellence, consider a member from the center
• Members Conflict of Interest members may not
  participate in discussion or vote if in conflict
  (leave the room!)

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RD CommitteeOverall RD Program Oversight

• Plan develop broad objectives
• Determine extent to which RD program has met its
  objectives
• Review budgetary other resource needs
• Oversee all RD activities 2 new areas
• Security of VA Protected Information
• Credentialing privileging
• Review certain written agreements
• Review evaluate all subcommittees

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RD CommitteeOverall RD Program Oversight

• Oversight is NOT the same as daily management
• Staff should provide sufficient information to
  fulfill areas of responsibility, but not a deluge

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Annual Reviews should be prepared by RD staff
for

• Publications
• Research employees privileges scopes of
  practice
• WOCs
• CRADAs and other agreements
• Research Biosafety and Biosecurity
• Privacy and Information Security
• Animal Program
• Human Research Protection Program

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RD CommitteeReview of Research

• Initial review of research
• Final approval only after receives approval from
  applicable subcommittees
• Continuing review to occur each year
• Review during a convened meeting
• Quorum required to approve research
• Majority of voting members present for discussion
  vote

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RD CommitteeReview of Research Includes

• Budget, supplies equipment needs
• VAPI (data) use, storage security
• Scientific merit
• Relevance to VA
• PIs qualifications
• Conflicts of Interest
• Personnel (incl. privileges scope of practice)
• Impact on facility (e.g., pharmacy, lab)

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It is key to review and approve each protocol
individually!
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For each project, the RD Committee should
consider

• Risks
• Rigor
• High quality science
• High standards of ethical conduct
• Relevance
• Will it benefit veterans?
• Is it right for our facility?
• Resources

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Just-In-Time

• Concurrence from RD Committee to submit after a
  preliminary review
• Appropriateness of scientific methodology
• Relevance of the research to VAs mission
• Investigators qualification
• Adequacy of resources
• Review by full board or expedited procedure

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Just-In-Time Continued

• Develop SOPs on how to conduct preliminary review
• Concurrence ? approval to initiate research
• Prior to initiating research PI must
• Submit to required subcommittees (IRB, IACUC
  etc,)
• Submit to RD Committee
• Obtain approvals in writing from all

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What Makes a Committee Effective?

• Thorough (assess the environment fully)
• Imaginative (looks for creative solutions)
• Deliberate (make decisions and carry them out)
• Timely (responds promptly proactive)
• Efficient (dont waste members time)

From Griffith, The Well-Managed Health Care
Organization
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How to get there

• Prioritization
• Clear mission
• Use calendar and agenda appropriately
• Preparation
• Read ahead materials
• Members who understand the environment
• Focus
• Address issues one-at-a-time to understand all
  angles
• Avoid purely ritualistic reviews
• Delegation (with accountability)
• Designated reviewers
• Subcommittees

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RD Committee Operations

• SOPs for all recurring activities
• Record keeping
• Maintain records of all activities applicable
  communications
• Minutes kept for committee subcommittees
• Record keeping may be by committee itself or
  others in research office
• Annually review operations/function of the
  committee

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Subcommittees

• Required subcommittees
• IRB
• IACUC
• Biosafety
• Option for other subcommittees
• Scientific review
• Continuing review
• Others as needed

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Tension Accountability versus Redundancy
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Tension Accountability versus Redundancy

• Dont redo the work of subcommittees or Merit
  review, BUT
• Review should be sufficient for the committee to
  understand what the project entails in terms of
• Risks
• Rigor
• Relevance
• Resources

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Checklists alone do not assure oversight!

• Audits
• Walk-arounds
• Communicate up, down, and sideways
• Staff, investigators
• Veterans
• Senior management
• Key services (pharmacy, privacy, IT)
• Situational awareness

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Affiliate Relationships

• An area of ongoing scrutiny
• Blue Ribbon Panel
• IG
• Congress
• If using their IRB or IACUC
• Strong MOU
• Must see the minutes
• Must be apprised promptly of compliance issues
• Must have appropriate and active VA
  representation
• Using an affiliates subcommittee will add to the
  RD Committees work

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Gray Areas

• Research that is conducted in space that VA
  leases to a non-VA entity
• University research (e.g., NIH projects)
  involving an investigator with a dual appointment
• Why worry? VA is responsible for all its research

SOLD
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Bottom Line

• Each VA facility must assume responsibility for
  all its research
• Medical Center Director and ACOS/RD have
  ultimate responsibility for what happens
• Research Office and RD committee have oversight
  responsibility for local VA research
• VA has some requirements that are beyond those of
  other entities (e.g., affiliates)