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Institutional Responsibilities for Research. K. Lynn Cates, MD Assistant Chief Research & Development Officer. Bottom Line. Each VA facility must assume responsibility for all its research Medical Center Director and ACOS/R&D have ultimate responsibility for what happens

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institutional responsibilities for research

Institutional Responsibilities for Research

K. Lynn Cates, MD

Assistant Chief Research & Development Officer

bottom line
Bottom Line
  • Each VA facility must assume responsibility for all its research
  • Medical Center Director and ACOS/R&D have ultimate responsibility for what happens
  • Research Office and R&D Committee have oversight responsibility for local VA research
  • VA has some requirements that are beyond those of other entities (e.g., affiliates)
slide4

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

slide5

The Media’s 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

role of va local accountability
Role of VA Local Accountability
  • Maintain the public’s 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
    • It’s what gets measured
institutional official io
Institutional Official (IO)
  • Medical Center Director (MCD) is the IO
  • MCD responsible for all aspects of the R&D program
  • MCD is responsible for ensuring adequate resources & administrative support. Examples:
    • Personnel
    • Space
    • Equipment
    • Education & training opportunities
    • Etc.
what is va research
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 R&D Committee is responsible for approval and oversight of all VA research
scope of r d committee
Scope of R&D Committee
  • Responsible through the COS to the Medical Center Director, for oversight of the research program
  • ACOS/R&D & AO/R&D assist the Committee with its duties
scope of r d committee10
Scope of R&D Committee
  • Responsible for maintaining high standards throughout the R&D 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
scope cont
Scope (Cont.)
  • R&D Committee approval must be obtained prior to initiating any research
  • Applicable “subcommittee” approvals must be obtained prior to final R&D Committee approval
  • R&D Committee may serve as the R&D Committee of record for another VA
    • MOU required
    • Local accountability is key
complementary roles
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

Complementary Roles

R&D Committee

ACOS/Research Office

r d committee membership
R&D 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
r d committee membership14
R&D 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 R&D Committee of another facility, consider having 1 member from that facility
  • Other voting or non-voting members as required
r d committee membership15
R&D 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
r d committee membership16
R&D 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!)
r d committee overall r d program oversight
R&D CommitteeOverall R&D Program Oversight
  • Plan & develop broad objectives
  • Determine extent to which R&D program has met its objectives
  • Review budgetary & other resource needs
  • Oversee all R&D activities: 2 new areas
    • Security of VA Protected Information
    • Credentialing & privileging
  • Review certain written agreements
  • Review & evaluate all “subcommittees”
r d committee overall r d program oversight18
R&D CommitteeOverall R&D Program Oversight
  • Oversight is NOT the same as daily management
  • Staff should provide sufficient information to fulfill areas of responsibility, but not a deluge
annual reviews should be prepared by r d staff for
Annual Reviews should be prepared by R&D 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
r d committee review of research
R&D 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
r d committee review of research includes
R&D CommitteeReview of Research Includes
  • Budget, supplies & equipment needs
  • VAPI (data) use, storage & security
  • Scientific merit
  • Relevance to VA
  • PI’s qualifications
  • Conflicts of Interest
  • Personnel (incl. privileges & scope of practice)
  • Impact on facility (e.g., pharmacy, lab)
for each project the r d committee should consider
For each project, the R&D 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
just in time
“Just-In-Time”
  • Concurrence from R&D Committee to submit after a preliminary review
    • Appropriateness of scientific methodology
    • Relevance of the research to VA’s mission
    • Investigator’s qualification
    • Adequacy of resources
  • Review by full board or expedited procedure
just in time continued
“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 R&D Committee
      • Obtain approvals in writing from all
what makes a committee effective
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 (don’t waste members time)

From Griffith, “The Well-Managed Health Care Organization”

how to get there
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
r d committee operations
R&D 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
subcommittees
“Subcommittees”
  • Required “subcommittees”:
    • IRB
    • IACUC
    • Biosafety
  • Option for other “subcommittees”
    • Scientific review
    • Continuing review
    • Others as needed
tension accountability versus redundancy32
Tension: Accountability versus Redundancy
  • Don’t 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
checklists alone do not assure oversight
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
affiliate relationships
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 affiliate’s subcommittee will add to the R&D Committee’s work
gray areas
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

bottom line36
Bottom Line
  • Each VA facility must assume responsibility for all its research
  • Medical Center Director and ACOS/R&D have ultimate responsibility for what happens
  • Research Office and R&D committee have oversight responsibility for local VA research
  • VA has some requirements that are beyond those of other entities (e.g., affiliates)