The Research

1
The Research Development Committee

• Brenda Cuccherini, Ph.D., MPH
• September 2007

2
The Old The New Policy

• Old policy M-3, Part 1, Chapters 2-3 very
  similar to 1200.1
• Changes include
• Membership
• More subcommittees allowed
• Approve pending for limited circumstances
• Just-in-Time

3
Equal But Different

• ACOS responsible for
• Day to day management operations of research
  program
• RD Committee responsible for
• Broad oversight of research program
• Rigorous review of research projects

4
Research Office vs RD Committee Complimentary
Roles
RD Committee
ACOS/Research Office

• 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

5
Scope of RD Committee

• Responsible through the COS to the Medical Center
  Director, for oversight of the research program
• Responsible for maintaining high standards
  throughout the RD program
• Assuring scientific ethical quality of research
• ACOS/RD AO/RD assist the Committee with its
  duties

6
Scope (Cont.)

• RD Committee approval must be obtained prior to
  initiating any research
• Applicable subcommittee approvals must be
  obtained prior to final RD Committee approval
• A RD Committee may serve as the RD Committee of
  record for another VA
• MOU required
• Local accountability is a key point

7
Committee Membership

• Members expertise reflect the types of research
  being conducted
• At least 5 voting members
• All voting members must be full time or permanent
  part time Federal employees
• At least 2 VA staff members with clinical or
  administrative duties
• At least 2 investigators that are actively
  engaged in research
• If affiliated with a university, 1 member who
  holds an academic appointment is a Federal
  employee

8
Committee Membership (Cont.)

• If conducting research involving investigational
  drugs, consider including 1 person from research
  pharmacy or Pharmacy service (voting or
  non-voting member)
• If serving as RD Committee of another facility,
  consider having 1 member from that facility
• Other voting or non-voting members as required by
  research program

9
Committee Membership (Cont.)

• Voting members may fill more than one role
• Ad hoc non-voting members may be used (OK if
  non-Federal if advice/ give facts only)
• Ex-officio, non-voting members include
• ACOS
• COS
• MCD
• Compliance officer
• AO

10
Committee Membership (Cont.)

• 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!)

11
RD 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

12
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 takes responsibility
• Auditing
• Personnel actions
• Providing research related injury care
• Liability

13
Program Oversight
14
Overall RD Program Oversight

• Plan develop broad objectives
• Determine extent to which RD program has met its
  objectives
• Review budgetary other resource needs
• Oversee all RD activities 2 new areas
• Security of VA Protected Information
• Credentialing privileging
• Review certain written agreements
• Review evaluate all subcommittees

15
Overall RD Program Oversight

• Oversight is NOT the same as daily management
• Advise, do not micromanage
• Staff should provide sufficient information to
  fulfill areas of responsibility, but not a deluge

16
Annual Reviews should be prepared by RD staff
for

• Publications
• Research employee privileges scope of practice
• WOCs
• CRADAs and other agreements
• Research Safety and Security
• Animal Program
• HRPP

17
How to get there

• Prioritization
• Clear mission
• Use calendar and agenda appropriately
• Preparation
• Read ahead
• Members who understand the environment
• Focus
• look at issues one-at-a-time to understand all
  angles
• Avoid purely ritualistic reviews
• Delegation (with accountability)
• Designated reviewers
• Subcommittees

18
Tension Accountability versus Redundancy

• Dont redo the work of subcommittees or Merit
  review, BUT
• Someone DOES need to look at the protocol
  sufficiently to understand what the project
  entails in terms of
• Risk
• Relevance
• Resources

19
Reviewing Research
20
Unapproved research can not be conducted at the
VA!!!
21
What is VA Research?

• Must decide if the project is research first.
• The definition used by VHA
• The testing of concepts by the scientific method
  of formulating a hypothesis or research question,
  systematically collecting and recording relevant
  data, and interpreting the results in terms of
  the hypothesis or question.
• A systematic investigation, including research
  development, testing and evaluation, designed to
  develop or contribute to generalized knowledge
  (38 CFR 16)

22
What Is VA Research?

• Conducted by persons appointed to the VA
• While on duty (compensated, WOC, IPA)
• Conducted using any VA resources
• Computer systems, labs, space, pharmacy service,
  VA software, etc.
• Conducted at the VA (medical center, stand-alone
  clinics or administrative space, space rented by
  VA)

23
What Type of Research? Is Subcommittee Review
Required?

• Human subjects
• Involves VA data or information All information
  that is obtained, developed, or produced by, or
  for its employees as part of its activities or
  operations
• My or may not be human subjects research
• Animal
• Bench or basic

24
Subcommittees

• Required subcommittees
• IRB
• IACUC
• Biosafety
• Option for other subcommittees
• Scientific review
• Continuing review
• Others as needed (space, resources, finance,
  etc.)

25
Review of Research

• Initial review of research
• Final approval only after receive 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

26
Review of Research (Cont.)

• Review includes
• Budget, supplies equipment needs
• VAPI (data) use, storage security
• Scientific merit
• Relevance to VA
• PIs qualifications
• Conflicts of Interest
• Personnel including responsibilities working
  within privileges scope of practice

27
For Each Project, the RD Committee Should
Consider

• Risks
• Rigor
• High quality science
• High standards of ethical conduct
• Relevance
• Will it benefit veterans?
• Is it right for our facility?
• Does it involve non-veterans?
• Resources

28
Approve Pending

• May approve, approve with conditions, or
  disapprove
• Approve with conditions pending either changes
  required by the RD or its subcommittee(s)
  approval(s)
• Subcommittee does not require any significant
  changes
• Chair, voting member , or full committee must
  review non-significant findings of
  subcommittee then give final approval
• If significant findings protocol with changes
  must be reviewed by the full RD Committee at
  convened meeting.

29
Just-In-Time

• Concurrence from RD Committee to submit after a
  preliminary review by committee
• Appropriateness of scientific methodology
• Relevance of the research to VAs mission
• Investigators qualification
• Adequacy of resources
• Review by full board or expedited procedure

30
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 RD Committee
• Obtain approvals from all

31
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 affiliates subcommittee will add to the
  RD Committees work