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Research & Development Committee

Brenda Cuccherini, Ph.D., MPH

Office of Research & Development

January 2007

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Word of Caution

• This talk is based on the DRAFT R&D Committee Handbook

• Unlikely but requirements may change before the USH signs it into policy

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"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

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Equal But Different

• ACOS responsible for:– Day to day management & operations of

research program

• R&D Committee responsible for:– Broad oversight of research program– Rigorous review of research projects

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Scope of R&D Committee

• Responsible through the COS to the Medical Center Director, for oversight of the research program

• Responsible for maintaining high standards throughout the R&D program

• Assuring scientific & ethical quality of research

• ACOS/R&D & AO/R&D assist the Committee with its duties

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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

• A R&D Committee may serve as the R&D Committee of record for another VA only– MOU required– Local accountability is a key point

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Specific Areas

• Plan & develop broad objectives• Determine extent to which R&D committee has

met its objectives• Review budgetary & other resource needs• Oversee all R&D activities: 2new areas

– Security of VA Protected Information– Credentialing, privileges, scope of practice

• Review certain written agreements• Review & evaluate all “subcommittees”

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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.

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R&D Committee Membership

• Draft policies do change!– Unlikely at this point

• Changes made since last Local Accountability presentation

• Based on OGC’s opinion and FACA requirements

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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

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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 R&D Committee of another facility, consider having 1 member from that facility

• Other voting or non-voting members as required by research program

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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

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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

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“Subcommittees”

• Required “subcommittees”:– IRB– IACUC– Biosafety

• Option for other “subcommittees”– Scientific review– Continuing review– Others as needed

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Responsibilities Related to the Facility’s 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

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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

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Review of Research (Cont.)

• Review includes: – Budget, supplies & equipment needs – VAPI (data) use, storage & security – Scientific merit– Relevance to VA – PI’s qualifications– Conflicts of Interest– Personnel including responsibilities & working

within privileges & scope of practice

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“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

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“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 from all

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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

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The Committee’s Life Expectancy

Not even computers will replace

committees, because committees buy

computers.

Edward Shepherd Mead

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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

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The important thing is not to stop

questioning.

Albert Einstein

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