Local Accountability Program Overview

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VA Research Accountability Meeting
Joel Kupersmith, MD Chief Research Development
Officer
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VA Research Development Mission
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VA Research Mission

• To make discoveries and create innovations that
  advance the health and care of veterans and the
  nation.

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Rich 60 Year History

• 3 Nobel Laureates, 6 Lasker Award Winners
• Important Discoveries and Inventions
• Cardiac Pacemaker
• First liver transplant
• Radioimmunoassay
• CT Scanner
• First large scale clinical trial TB
• Cooperative Studies Program Trials strongly
  influence medical practice
• Comparative Effectiveness Research

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Rich 60 Year History (cont.)

• Deep brain stimulation for Parkinsons Disease
• Pinpointing genes for diabetes and obesity
• Brain-computer interface to restore independence
  to paralyzed veterans
• Proper use of coronary angioplasty - COURAGE
  trial
• Vaccine for Shingles
• Prolonged Exposure Therapy for PTSD
• First rehabilitation program for blind persons
• Linked smoking with cancer of the respiratory
  tract and lung
• Developed the Seattle Footfirst prosthesis
  allowing amputees to run and jump

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Why VA Research is Essential
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Why VA Research is Essential

• Critical to improving clinical care in the VA
  Healthcare System
• Advances the health of veterans and the nation
• Improves the lives of veterans
• Focuses entirely on veteran-centric initiatives
• Recruit retain the best clinicians
• Residency programs
• National impact

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Summary of Genomics Survey Findings

• 83 said program should be done
• 71 would participate
• Participation associated with
• Attitudes about research
• Attitudes about helping and history of previous
  altruistic behaviors
• Curiosity about genetics
• Satisfaction with VA
• Demographic differences
• Patient protection and privacy were important

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Q21 Do you think research should be allowed or
prohibited on
( allowed)
Cancer
Mental illness
PTSD
Alcoholism
Suscept. to env. exp.
Athletic ability
Stem cell research
Cloning
Confidential. N931. Weighted. GPPC 2008
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Meeting Purpose
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Meeting Purpose

• Design a plan for an ongoing local program
  to heighten awareness of research issues and
  instill a responsible culture for conducting
  research
• Compliancea particular challenge for many
  reasons which we will explore and together
  overcome
• Foster a culture where compliance is everyones
  responsibility

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Compliance Initiatives

• Many vulnerabilities in the VA system in research
  compliance
• Large system with 117 VAMCs with research
  capacity
• We have been aware of the vulnerabilities for a
  long time and are working to correct them
• Started initiatives for patient protection well
  before events of this last summer
• Research Administrative Review an example

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VA Culture
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Culture

• VA culture is positive
• Combination of medicine, clinical care, and
  academics, with a veteran-centric mission
• VAMC administrative teams are highly competent
• Development and application of EHR and quality
  programs are some of its accomplishments
• We need to strengthen and reinforce research
  compliance in the VA culture

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Culture

• Administrative Culture
• Research Culture
• Creativity is intrinsic to research

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Creating a Culture of Research Compliance in
VAMCsPrinciples(for thought)
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Principals to Create a Culture of Research
Compliance

• Patient protection is part of clinical care
• Patient protection is an imperative
• All components of patient protection work
  together
• Everyone in the Medical Center has responsibility
  and is held accountable
• Human protections and compliance are part of
  every day routine

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Principles for Culture of Compliance (cont.)

• Culture that encourages self-policing and good
  intent reporting
• Prevention as well as policing, anticipate the
  next battle and dont just fight the last
  onetake control, be proactive
• Make research compliance public, e.g., public
  display of research patient protection principles
• Implement change, e.g., post-conference events in
  Medical Centers

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Patient Protection is Part of Clinical Care

• Clinical care is the first VHA mission
• Clinical research is part of clinical care
• Special obligations
• Research patients take special risks to help
  themselves and everyone
• Patients entrust themselves to us
• There is uncertainty
• Gives us special obligations which should be the
  basis of our behavior

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Patient Protection is an Imperative

• Part of clinical care and quality and therefore
  imperative
• If goes wrong, the ultimate effect will be harm
  to patients
• Little things matter
• Prevent sloppiness
• First reaction in often This is not important
  You are making a big thing about nothing
• Paperwork problems precede clinical problems

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All Components of Patient Protection Need to Work
Together

• All components need to work together
• VAMCs
• VISNs
• ORD
• ORO
• OIG
• Privacy
• Affiliates
• Others
• Each has its role

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Compliance Responsibilities

• Office of Research Oversight
• Oversight
• Monitor, review, investigate
• Audits, inspections, examination for wrongdoing,
  etc
• Can stop research and close programs
• Has done so recently
• Can also recommend debarment of investigators
• Education of Research Compliance Officers
• Recently added function
• Office of the Inspector General
• Investigate, make recommendations to Secretary

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Compliance Responsibilities

• Office of Research and Development
• Policies, rules, etc.
• How research is done
• Funding
• Cannot close programs but can stop funding
• Education and provision of information
• Reporting on research activities
• Medical Center/VISN facility level
• Medical Center Director Is the Institutional
  Official for research under the Federal Wide
  Assurance and is responsible for appropriate
  conduct of research in the institution
• Responsible for carrying out the rules out and
  seeing that patient protection is accomplished
• Privacy Office
• Affiliates

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Everyone in the Medical Center Has Responsibility
is Accountable

• Not just researchers - Everyone in VAMC has to
  feel a responsibility for patient protection
• Professionals and non-professionals
• Everyone has to feel accountable and be held
  accountable
• Permeate the institution with the attitude of
  patient protection
• Checks and balances

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Human Protection and Compliance Part of Routine

• Not only should everyone be involved but it
  should also be a routine part of every day in
  Medical Centers and the VA as a whole
• Should be intrinsic to the culture

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Culture that encourages self-policing and good
intent reporting

• Create a system for self reporting, and reporting
  with good intent (e.g., non-vindictive)
• Non-punitive
• Option for anonymous
• Make staff aware

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Prevention As Well As Policing

• Policing
• Audits, oversight, etc.
• Need the capacity to act quickly and
  appropriately with all the VA can bring to bear
• But policing is not enough need Prevention
• Not enough just to keep doing more of the same
  things at a more intense level
• This wont completely solve the problem

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Prevention as well as Policing(cont.)

• Anticipate the next challengedont just manage
  through the last one
• Be proactive, take control
• History
• Plan for the unplanned -what will happen next is
  often unpredictable
• Murphys law
• Creating fundamentals and infrastructure will
  prepare the MC to overcome the next challenge
• Includes training and education

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Make Research Compliance Public

• As example, display the institutions research
  patient protection Principles publicly
• Makes an important commitment to veterans
• Engages everyone

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Implement Change

• As example, undertake post-conference events in
  Medical Centers
• Commitment to the cause
• Engage everyone
• Part of this meeting will be to come up with
  ideas for this
• Make VA Research a Priorityoutside of Research
  Week

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Creating a Culture of Research Compliance Tools
and Vehicles

• Some possible tools and vehicles to add research
  compliance to the VA culture
• Training/Education/Drills
• Better use of Research and Development Committee
• Public declaration and display of Principles
• Research days
• Performance plans for all
• System of self reporting
• Incentives
• Constant reinforcement
• There is more that can be done You have the
  brain power

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VA Research Improving Veterans Lives Thank You