Research

1
Research Development Committee

• Brenda Cuccherini, Ph.D., MPH
• Office of Research Development
• January 2007

2
Word of Caution

• This talk is based on the DRAFT RD Committee
  Handbook
• Unlikely but requirements may change before the
  USH signs it into policy

3

• "I'm not a bit changed--not really. I'm only
  just pruned down and branched out. The real
  ME--back here--is just the same."
• Lucy Maud Montgomery
• Ann of Green Gables

4
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

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 only
• MOU required
• Local accountability is a key point

7
Specific Areas

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

8
Institutional Official (IO)

• Medical Center Director (MCD) is the IO
• MCD responsible for all aspects of the RD
  program
• MCD is responsible for ensuring adequate
  resources administrative support. Examples
• Personnel
• Space
• Equipment
• Education training opportunities
• Etc.

9
RD Committee Membership

• Draft policies do change!
• Unlikely at this point
• Changes made since last Local Accountability
  presentation
• Based on OGCs opinion and FACA requirements

10
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

11
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 serve as RD Committee of another facility,
  consider having 1 member from that facility
• Other voting or non-voting members as required by
  research program

12
Committee Membership (Cont.)

• Voting members may fill more than one criterion
  for required membership
• Ad hoc non-voting members may be used
• If non-Federal employee provide individual
  advise or exchange facts information only
• Ex-officio, non-voting members include
• ACOS, COS, MCD, compliance officer, AO

13
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

14
Subcommittees

• Required subcommittees
• IRB
• IACUC
• Biosafety
• Option for other subcommittees
• Scientific review
• Continuing review
• Others as needed

15
Responsibilities Related to the Facilitys
Research Program

• Have oversight responsibilities, not
  responsibilities for day to day management
• Need to receive sufficient information (annual,
  quarterly reports or other information) to
  fulfill areas of responsibility
• Information on compliance, QA, requests for WOC
  appointments, special programs such as
  Biosafety, Animal Welfare, HRPP

16
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

17
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

18
Just-In-Time

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

19
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

20
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

21
The Committees Life Expectancy

• Not even computers will replace
• committees, because committees buy
• computers.
• Edward Shepherd Mead

22
Remember

• M-3, Part 1, Chapter 2 3 is still policy until
  USH signs the new Handbook into policy.
• Draft HB consider as guidance
• ORD will send e-mail out when it is official
  policy
• Compliance with all requirements within 6 months

23

• The important thing is not to stop
• questioning.
• Albert Einstein

24
(No Transcript)