Research & Development Committee

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

5. 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

6. 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

7. 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”

8. 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.

9. 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

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 R&D 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 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

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 • PI’s qualifications • Conflicts of Interest • Personnel including responsibilities & working within privileges & scope of practice

18. “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

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 R&D Committee • Obtain approvals from all

20. 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

21. The Committee’s 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