va research accountability meeting joel kupersmith, md chief research & development officer
TRANSCRIPT
![Page 1: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/1.jpg)
VA Research Accountability Meeting
VA Research Accountability Meeting
Joel Kupersmith, MDJoel Kupersmith, MDChief Research & Development OfficerChief Research & Development Officer
![Page 2: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/2.jpg)
VA Research & Development Mission
![Page 3: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/3.jpg)
VA Research Mission
“To make discoveries and create innovations that advance the health and care of veterans and the nation.”
![Page 4: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/4.jpg)
Rich 60 Year History
• 3 Nobel Laureates, 6 Lasker Award Winners
• Important Discoveries and Inventionso Cardiac Pacemakero First liver transplanto Radioimmunoassayo CT Scanner
• First large scale clinical trial – TB
• Cooperative Studies Program – Trials strongly influence medical practice
• Comparative Effectiveness Research
![Page 5: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/5.jpg)
Rich 60 Year History (cont.)
• Deep brain stimulation for Parkinson’s 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 Foot—first prosthesis allowing amputees to run and jump
![Page 6: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/6.jpg)
Why VA Research is Essential
![Page 7: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/7.jpg)
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
![Page 8: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/8.jpg)
• 83% said program should be done
• 71% would participate
• Participation associated witho Attitudes about researcho Attitudes about helping and history of previous “altruistic
behaviors”o Curiosity about geneticso Satisfaction with VAo Demographic differences
• Patient protection and privacy were important
Summary of Genomics Survey Findings
![Page 9: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/9.jpg)
36
58
87
89
94
96
31
77
82
88
90
91
91
95
0 50 100
VA
US
Cloning
Q21: Do you think research should be allowed or prohibited on: (% allowed)
Confidential. N=931. Weighted. GPPC 2008
Stem cell research
Athletic ability
Suscept. to env. exp.Alcoholism
PTSD
Mental illness
Cancer
![Page 10: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/10.jpg)
Meeting Purpose
![Page 11: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/11.jpg)
Meeting Purpose
Design a plan for an ongoing local program to heighten awareness of research issues and instill a responsible culture for conducting research
• Compliance—a particular challenge for many reasons which we will explore and together overcome
• Foster a culture where compliance is everyone’s responsibility
![Page 12: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/12.jpg)
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 summero Research Administrative Review an example
![Page 13: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/13.jpg)
VA Culture
![Page 14: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/14.jpg)
Culture
• VA “culture” is positiveo Combination of medicine, clinical care, and
academics, with a veteran-centric mission
o VAMC administrative teams are highly competent
o Development and application of EHR and quality programs are some of its accomplishments
o We need to strengthen and reinforce research compliance in the VA culture
![Page 15: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/15.jpg)
Culture
• “Administrative Culture”• “Research Culture”
o Creativity is intrinsic to research
![Page 16: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/16.jpg)
Creating a Culture of Research Compliance
in VAMCs
Principles(for thought)
![Page 17: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/17.jpg)
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
![Page 18: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/18.jpg)
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 don’t just fight the last one—take 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
![Page 19: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/19.jpg)
Patient Protection is Part of Clinical Care
• Clinical care is the first VHA mission
• Clinical research is part of clinical care
• Special obligations”o Research patients take special risks to help
themselves and everyoneo Patients entrust themselves to uso There is uncertaintyo Gives us special obligations which should
be the basis of our behavior
![Page 20: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/20.jpg)
• Part of clinical care and quality and therefore imperative
• If goes wrong, the ultimate effect will be harm to patients
• Little things mattero Prevent sloppiness
• First reaction in often “This is not important” “You are making a big thing about nothing”
• Paperwork problems precede clinical problems
Patient Protection is an Imperative
![Page 21: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/21.jpg)
All Components of Patient Protection Need to Work Together
• All components need to work togethero VAMCs o VISNso ORDo OROo OIGo Privacyo Affiliateso Others
• Each has its role
![Page 22: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/22.jpg)
Compliance Responsibilities
• Office of Research Oversighto Oversight
Monitor, review, investigate Audits, inspections, examination for wrongdoing, etc
o Can stop research and close programs Has done so recently
o Can also recommend debarment of investigators
o Education of Research Compliance Officers Recently added function
• Office of the Inspector Generalo Investigate, make recommendations to
Secretary
![Page 23: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/23.jpg)
Compliance Responsibilities
• Office of Research and Developmento Policies, rules, etc.o How research is doneo Funding
Cannot close programs but can stop fundingo Education and provision of informationo Reporting on research activities
• Medical Center/VISN – facility levelo 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
o Responsible for carrying out the rules out and seeing that patient protection is accomplished
• Privacy Office• Affiliates
![Page 24: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/24.jpg)
Everyone in the Medical Center Has Responsibility & is Accountable
• Not just researchers - Everyone in VAMC has to feel a responsibility for patient protection o 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
![Page 25: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/25.jpg)
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
![Page 26: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/26.jpg)
Culture that encourages self-policing and “good intent” reporting
• Create a system for self reporting, and reporting with good intent (e.g., non-vindictive)o Non-punitive
• Option for anonymous• Make staff aware
![Page 27: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/27.jpg)
Prevention As Well As Policing
• Policingo Audits, oversight, etc.o Need the capacity to act quickly and
appropriately with all the VA can bring to bear
• But policing is not enough – need Preventiono Not enough just to keep doing more of
the same things at a more intense levelo This won’t completely solve the problem
![Page 28: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/28.jpg)
Prevention as well as Policing(cont.)
• Anticipate the next challenge—don’t just manage through the last one
o Be proactive, take controlo History
• Plan for the unplanned -what will happen next is often unpredictable
o Murphy’s law
• Creating fundamentals and infrastructure will prepare the MC to overcome the next challenge
• Includes training and education
![Page 29: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/29.jpg)
Make Research Compliance Public
• As example, display the institution’s research patient protection Principles publiclyo Makes an important commitment to veteranso Engages everyone
![Page 30: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/30.jpg)
Implement Change
• As example, undertake post-conference events in Medical Centerso Commitment to the causeo Engage everyoneo Part of this meeting will be to come up with
ideas for this
• Make VA Research a Priority—outside of Research Week
![Page 31: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/31.jpg)
Creating a Culture of Research Compliance – Tools and Vehicles
• Some possible tools and vehicles to add research compliance to the VA cultureo Training/Education/Drillso Better use of Research and Development
Committeeo Public declaration and display of Principleso Research dayso Performance plans for allo System of self reportingo Incentiveso Constant reinforcemento There is more that can be done – You have the
brain power
![Page 32: VA Research Accountability Meeting Joel Kupersmith, MD Chief Research & Development Officer](https://reader035.vdocuments.site/reader035/viewer/2022062713/56649cf65503460f949c5921/html5/thumbnails/32.jpg)
VA Research:Improving Veterans’ Lives
Thank You
VA Research:Improving Veterans’ Lives
Thank You