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Local Accountability Program Overview

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'To make discoveries and create innovations that advance the ... Audits, inspections, examination for wrongdoing, etc. Can stop research and close programs ... – PowerPoint PPT presentation

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Title: Local Accountability Program Overview


1
VA Research Accountability Meeting
Joel Kupersmith, MD Chief Research Development
Officer
2
VA Research Development Mission
3
VA Research Mission
  • To make discoveries and create innovations that
    advance the health and care of veterans and the
    nation.

4
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

5
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

6
Why VA Research is Essential
7
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

8
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

9
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
10
Meeting Purpose
11
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

12
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

13
VA Culture
14
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

15
Culture
  • Administrative Culture
  • Research Culture
  • Creativity is intrinsic to research

16
Creating a Culture of Research Compliance in
VAMCsPrinciples(for thought)
17
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

18
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

19
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

20
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

21
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

22
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

23
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

24
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

25
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

26
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

27
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

28
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

29
Make Research Compliance Public
  • As example, display the institutions research
    patient protection Principles publicly
  • Makes an important commitment to veterans
  • Engages everyone

30
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

31
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

32
VA Research Improving Veterans Lives Thank You
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