VA Research Accountability Meeting

VA Research Accountability Meeting

Joel Kupersmith, MDJoel Kupersmith, MDChief Research & Development OfficerChief Research & Development Officer

VA Research & Development Mission

VA Research Mission

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

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

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

Why VA Research is Essential

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

• 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

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

Meeting Purpose

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

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

VA Culture

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

Culture

• “Administrative Culture”• “Research Culture”

o Creativity is intrinsic to research

Creating a Culture of Research Compliance

in VAMCs

Principles(for thought)

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

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

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

• 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

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

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

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

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

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

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

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

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

Make Research Compliance Public

• As example, display the institution’s research patient protection Principles publiclyo Makes an important commitment to veteranso Engages everyone

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

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

VA Research:Improving Veterans’ Lives

Thank You

VA Research:Improving Veterans’ Lives

Thank You